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For calculating the chronic dietary exposure to nivalenol, food consumption and body weight data at the individual level were accessed in the Comprehensive Database. For each country, exposure estimates were calculated per dietary survey and age class (see Section 5.1.1). Exposure estimates were therefore calculated for 28 different dietary surveys carried out in 17 different European countries. Not all countries provided consumption information for all age groups or in some cases the same country provided more than one consumption survey.

The mean dietary exposure (average consumption in total population) and the high dietary exposure (95th _{percentile food consumption in total population) to nivalenol were calculated separately for each} dietary survey using consumption data recorded at the individual level. Individual food consumption data were combined with the mean occurrence values in order to provide mean and high percentile exposure estimates (95th _{percentile). Exposure estimates were calculated for both LB and UB} scenarios. The LB and UB mean concentrations of the food groups used in the exposure calculation are presented in Table 4. It should be noted that 90 % of the data were left-censored resulting in a large difference between the dietary exposure estimates in LB and UB scenarios.

Minimum, median and maximum exposure estimates across dietary surveys are reported in Table 10. Detailed mean and 95th _{percentile dietary exposure estimates calculated for each of the 28 dietary} surveys are presented in Table 11. In accordance with the specifications of the EFSA Guidance on the use of the Comprehensive database (EFSA, 2011b), 95th _{percentile estimates for dietary surveys/age} classes with less than 60 observations may not be statistically robust and therefore they should not be considered in the risk characterisation.

6.1.2.1. Infants (< 12 months old)

Only two dietary surveys reported consumption data for children younger than 1 year, therefore the dietary exposure estimate cannot be considered as representative of the European infant population. One of the surveys did not qualify for the calculation of the 95th percentile exposure (number of subjects < 60). The mean dietary exposure to nivalenol was 2.4 and 140 ng/kg b.w. per day (minimum LB to maximum UB) in these two surveys. The 95th _{percentile dietary exposure in the one qualifying} study was 16 ng/kg b.w. per day in LB and 389 ng/kg b.w. per day in UB (Tables 10 and 11).

6.1.2.2. Children and adolescents (≥ 1 to < 18 years old)

The estimated dietary exposure to nivalenol in toddlers, other children and adolescents decreased with increasing age due to the higher intake of food per kg b.w. in younger age groups. The highest exposure was estimated in toddlers (age ≥ 12 months to < 36 months), for which mean chronic dietary exposure ranged from 4.3 to 202 ng/kg b.w. per day (minimum LB to maximum UB) and the 95th _{percentile dietary exposure ranged from 12 to 484 ng/kg b.w. per day (minimum LB to maximum} UB) (Tables 10 and 11).

6.1.2.3. Adults (≥ 18 to < 65 years old)

In the adult population, the mean dietary exposure to nivalenol across dietary surveys ranged from 0.4 to 75 ng/kg b.w. per day (minimum LB to maximum UB). The 95th _{percentile dietary exposure} ranged from 1.1 to 224 ng/kg b.w. per day (minimum LB to maximum UB) (Tables 10 and 11).

6.1.2.4. Elderly and very elderly (≥ 65 years old)

The mean dietary exposure estimates in elderly and very elderly across the dietary surveys ranged from 0.8 to 58 ng/kg b.w. per day (minimum LB to maximum UB). The 95th percentile dietary exposure ranged from 1.9 to 127 ng/kg b.w. per day (minimum LB to maximum UB) (Tables 10 and 11).

6.1.2.5. Conclusions

Dietary exposure to nivalenol in the adult population across 14 European countries, using LB and UB concentrations, ranged from 0.4 to 75 ng/kg b.w. per day for average consumers, and 1.1 to 224 ng/kg b.w. per day for high consumers. The highest chronic exposure was estimated in toddlers (age > 12 months to < 36 months) ranging from 4.3 to 202 ng/kg b.w. per day for average consumers, and 12 to 484 ng/kg b.w. per day for high consumers. A relatively high variation between the exposure estimates across the dietary surveys within each age class was observed. The exposure estimates in this assessment are generally in the same range as those reported in previous assessments (see Section 6.1.1.1). A summary of the dietary exposure to nivalenol in all age classes is presented in Table 10.

Table 10: Summary statistics of the chronic dietary exposure to nivalenol (ng/kg b.w. per day) across European countries.

Age class Summary statistics of exposure (ng/kg b.w. per day)

Minimum Median Maximum

LB UB LB UB LB UB Mean dietary exposure in total population

Infants 2.4 136 -(a) _-(a) _{4.4 140}

Toddlers 4.3 81 6.3 152 8.8 202 Other children 1.3 56 5.5 97 12 132 Adolescents 1.0 45 2.1 60 6.4 80 Adults 0.40 37 1.6 56 4.8 75 Elderly 0.81 31 1.7 49 4.7 55 Very elderly 0.80 43 1.6 49 3.9 58

95th _{percentile dietary exposure in total population}(b)

Infants 16 -(c) _-(c) _-(c) _-(c) ₃₈₉ Toddlers 12 203 15 317 23 484 Other children 3.0 121 12 179 22 259 Adolescents 3.0 99 6.0 124 15 147 Adults 1.1 89 4.0 112 10 224 Elderly 2.3 60 3.5 102 11 127 Very elderly 1.9 79 3.8 100 7.8 111

b.w.: body weight; LB: lower-bound; UB: upper-bound;

(a): Not calculated; estimates available only from two dietary surveys;

(b): The 95th _{percentile estimates obtained on dietary surveys/age classes with less than 60 observations may not be}

statistically robust (EFSA, 2011b) and therefore they should not be considered in the risk characterisation. Those estimates were not included in this table;

Table 11: Mean and 95th _{percentile (P95) chronic dietary exposure to nivalenol (ng/kg b.w. per day) for total population (lower-bound – upper-bound}

scenarios) for each dietary survey.

Dietary survey(a)

Infants Toddlers Other children Adolescents Adults Elderly Very elderly

Mean P95 Mean P95 Mean P95 Mean P95 Mean P95 Mean P95 Mean P95 BE/1 1.8-62 4.8-137 1.4-59 4.0-139 0.81-47 2.3-117 0.8-44 2.1-96 BE/2 6.3-149 17-248(b) 5.8-121 16-221 BG 4.4-140 16-389 7.1-152 17-265 5.5-128 15-245 CY 3.1-54 7.9-114 CZ 7.9-89 19-161 6.4-69 15-142 3.3-75 8.7-224 DK 6.2-97 12-154 3.9-62 9.0-112 2.1-57 4.8-121 1.7-53 3.4-102 2.0-54 5.0-135(b) FI/1 8.7-81 23-203 12-67 22-121 FI/2 4.8-40 10-93 4.7-31 11-60 FI/3 1.3-62 3.0-137 FR 4.3-88 9.4-162 2.7-58 6.5-115 1.6-47 4.3-98 1.0-45 2.8-98 0.94-43 1.9-79 DE/1 4.6-202 12-483 5.1-101 12-182 DE/2 4.8-171 12-368 5.8-102 13-179 DE/3 4.3-178 13-484 5.5-104 11-182 DE/4 1.8-57 5.6-132 1.2-55 3.9-140 1.1-50 3.5-127 1.1-43 3.8-101 GR 6.7-85 15-192 HU 4.0-56 7.9-111 3.4-49 7.7-88 3.9-53 7.8-100 IE 1.6-75 3.5-199 IT 2.4-136 12-485(b) 8.8-188 30-375(b) 7.6-132 18-259 5.9-78 14-147 4-59 9-106 2.6-55 6.4-102 2.4-58 5.5-111 LV 1.7-56 5.1-161 1.0-47 3.0-110 0.5-37 1.7-91 NL/1 0.8-65 1.8-185 NL/2 8.8-140 20-264 6.9-120 17-225 ES/1 1.7-48 4.8-112 ES/2 1.5-51 4.1-103 1.4-43 3.4-89 ES/3 3.4-118 8.2-226 2.2-80 5.3-146 ES/4 4.6-123 27-331(b) 2.8-94 7.6-166 2.0-71 5.4-142 SE/1 2.0-67 4.2-144 1.4-45 3.1-99 SE/2 0.4-42 1.1-89 UK 1.4-64 3.3-159

BE: Belgium; BG: Bulgaria; CY: Cyprus; CZ: Czech Republic; DK: Denmark; FI: Finland; FR: France; DE: Germany; GR: Greece; HU; Hungary; IE: Ireland; IT: Italy; LV: Latvia; NL: the Netherlands; ES: Spain; SE: Sweden; UK: United Kingdom; P95: 95th _percentile;

(a): Original acronyms of the dietary surveys and the number of subjects is given in Table 8; (b): P95 estimates for dietary surveys/age classes with less than 60 observations may not be statistically robust (EFSA, 2011b) and therefore they should not be considered in the risk characterisation.