efsa-opinion-chromium-food-drinking-water
efsa-opinion-chromium-food-drinking-water efsa-opinion-chromium-food-drinking-water
Chromium in food and drinking water 320.2 ng/kg b.w. per day (minimum LB - maximum UB) for 95 th percentile consumption, with the highest exposure estimated for infants. The MOEs for the different age groups across the different European dietary surveys calculated on the basis of the selected RP vary for the different ages groups as shown in Table 24 for mean and 95 th percentile exposure when calculated for both LB and UB exposure estimates. The MOEs indicate low concern regarding Cr(VI) intake via the consumption of water intended for human consumption and mineral waters for all age groups when considering the mean chronic exposure values with the exception of infants at UB exposure estimates. However, the exposure assessment for infants should be cautiously taken because only two surveys were available for this age group. The MOEs calculated taking into account the 95 th percentile exposures to Cr(VI) indicate a potential concern, but only at UB exposure estimates and particularly for ‘Infants’, ‘Toddlers’ and ‘Other children’ age groups. When interpreting these MOEs, it should be considered that there is a remarkable influence of left-censored data (91.3 % of the total data) on the UB estimates since UB occurrence values were 10-fold higher than LB for the most consumed water, i.e. tap water. Moreover, these MOEs were calculated by using as RP the BMDL 10 derived from dose-response analysis of incidence of tumours (combined incidence of adenomas and carcinomas) in the small intestine of mice. There is evidence of differences in anatomy and functional properties of the stomach in rodents and in humans that are expected to impact significantly on the efficiency of Cr(VI) reduction in the GI tract. Efficient Cr(VI) reduction in the GI tract would reduce chances of cellular uptake and subsequent induction of genotoxicity/carcinogenicity. In particular, the reduction capacity of rodents is expected to be significantly lower than that of humans, which makes rodents a worst case model for human carcinogenicity. When interpreting the numerical value of the MOE it should be considered that there is a significant uncertainty associated with the use of tumour data in mice to estimate risk at doses of Cr(VI) relevant for human exposure. Based on the MOE values for neoplastic effects, the CONTAM Panel concluded that the current levels of exposure to Cr(VI) via the consumption of water intended for human consumption and mineral waters are of low concern from a public health point of view for average consumers but there might be a potential concern for high consumers particularly for ‘Infants’, ‘Toddlers’ and ‘Other children’. Table 24: Margin of exposure (MOE) calculated across the different European dietary surveys for Cr(VI) through the consumption of drinking water (water intended for human consumption and mineral waters) as such. MOEs are rounded to two significant digits. MOE (min LBmax UB) Mean exposure (a) Dietary surveys with MOE below 10 000/Total surveys (b) 95 th percentile exposure (a) MOE (min LB-max UB) Dietary surveys with MOE below 10 000/Total surveys (b) Infants (c) 71 000 - 6300 2/2 21 000 - 3100 1/1 Toddlers 130 000 - 11 000 0/9 62 000 - 4200 6/6 Other children 1 400 000 - 16 000 0/15 360 000 - 6600 9/15 Adolescents 1 200 000 - 23 000 0/10 350 000 - 9100 1/10 Adults 710 000 - 23 000 0/13 230 000 - 9200 1/13 Elderly 540 000 - 29 000 0/6 210 000 - 11 000 0/6 Very elderly 740 000 - 29 000 0/4 95 000 - 11 000 0/3 (a): Dietary surveys with less than 50 % consumers were not considered (surveys from Greece (age class ‘Other children’), Cyprus (age class ‘Adolescents’), Latvia (age classes ‘Other children’, ‘Adolescents’ and ‘Adults’) and Hungary (age classes ‘Adults’, ‘Elderly’ and ‘Very elderly’, see Table G2 in appendix); (b): Number of surveys with a MOE lower than 10000 at the UB; (c): Estimate only available from two dietary surveys for the mean and only one for the 95 th percentiles; The highest chronic exposure to Cr(VI) through the consumption of bottled water was estimated in the youngest population (‘Infants’ and ‘Toddlers’) (Table 10). Due to the lack of consumption data on bottled water, in several dietary surveys no exposure to Cr(VI) through the consumption of bottled EFSA Journal 2014;12(3):3595 116
Chromium in food and drinking water water could be estimated. The maximum estimates of chronic exposure to Cr(VI) in mean consumers were 149.8 ng/kg b.w. per day (UB) for infants, and 148.7 ng/kg b.w. per day (UB) for ‘Toddlers’ at the 95 th percentile exposure. In general, the exposure to Cr(VI) was lower than that estimated through the consumption of all types of water due to the small amount of consumption data reported for bottled water (27.7 % of the total). However, considering the estimates of exposure in several dietary surveys, the CONTAM Panel concluded that regarding the exposure to Cr(VI) through the consumption of bottled water there is a low concern from a public health point of view for average consumers but there might be a potential concern for high consumers particularly for ‘Infants’, ‘Toddlers’ and ‘Other children’ (see Table 25). Table 25: Margin of exposure (MOE) calculated across the different European dietary surveys for Cr(VI) through the consumption of bottled water. Dietary surveys with no exposure to Cr(VI) (no reported consumption on bottled water) were not considered when calculating the MOEs. MOEs are rounded to two significant digits. MOE (min LB-max UB) Mean exposure (a) 95 th percentile exposure (a) Dietary surveys with MOE below 10000/Total surveys (a) MOE (min LB-max UB) Dietary surveys with MOE below 10000/Total surveys (a) Infants (b) 140 000-6700 ½ 26 000-6900 1/1 Toddlers (c) 520 000 000-16 000 0/9 38 000-6700 4/6 Other children (c) 77 000 000-22 000 0/16 1 600 000-7900 5/16 Adolescents (c) 8 900 000-28 000 0/11 1 200 000-9300 1/11 Adults (c) 840 000 000-26 000 0/15 940 000-9400 1/15 Elderly (c) 8 900 000-35 000 0/7 1 700 000-11 000 0/7 Very elderly (c) 18 000 000-41 000 0/6 190 000-14 000 0/5 (a): Number of surveys with a MOE lower than 10000 at the UB; (b): Estimate only available from two dietary surveys for the mean and only one for the 95 th percentiles; (c): Those dietary surveys with 95 th percentile exposure equal to zero were not included in the MOE calculation (see Table 10). The inclusion of the water used in the preparation of specific foods (coffee, tea infusions, and dry infant and follow-on food mainly, but also some others such as instant soup, evaporated and dried milk, and dehydrated fruit juice) led to an increase up to two-fold of the exposure to Cr(VI). However, the CONTAM Panel was not able to consider this additional contribution to the exposure to Cr(VI) when deriving MOEs since no reliable data to quantify Cr(VI) in food exist. Non-neoplastic effects The BMDL 10 value of 0.11 mg Cr(VI)/kg b.w. per day for diffuse epithelial hyperplasia of the duodenum in male mice was selected as RP to estimate the MOE for non-neoplastic lesions. The comparison of this RP with estimated daily intakes of Cr(VI) via drinking water ranging up to 159.1 and 320.2 ng/kg b.w. per day (maximum UB for mean and 95 th percentile exposure) for the different age groups resulted in an MOE of 690 and 340, respectively. The BMDL 05 of 0.2 mg Cr(VI)/kg bw per day calculated for decreased haematocrit was selected as RP to estimate MOEs for haematological effects. The comparison of this reference point with estimated daily intakes of Cr(VI) via drinking water ranging up to 159.1 and 320.2 ng/kg b.w. per day (maximum UB for mean and 95 th percentile exposure) for the different age groups resulted in an MOE of 1300 and 630, respectively. The CONTAM Panel considered that for the critical thresholded effects, MOEs larger than 100 would indicate a low concern for human health and therefore concluded that for non-neoplastic lesions and EFSA Journal 2014;12(3):3595 117
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Chromium in <strong>food</strong> and <strong>drinking</strong> <strong>water</strong><br />
320.2 ng/kg b.w. per day (minimum LB - maximum UB) for 95 th percentile consumption, with the<br />
highest exposure estimated for infants. The MOEs for the different age groups across the different<br />
European dietary surveys calculated on the basis of the selected RP vary for the different ages groups<br />
as shown in Table 24 for mean and 95 th percentile exposure when calculated for both LB and UB<br />
exposure estimates.<br />
The MOEs indicate low concern regarding Cr(VI) intake via the consumption of <strong>water</strong> intended for<br />
human consumption and mineral <strong>water</strong>s for all age groups when considering the mean chronic<br />
exposure values with the exception of infants at UB exposure estimates. However, the exposure<br />
assessment for infants should be cautiously taken because only two surveys were available for this age<br />
group. The MOEs calculated taking into account the 95 th percentile exposures to Cr(VI) indicate a<br />
potential concern, but only at UB exposure estimates and particularly for ‘Infants’, ‘Toddlers’ and<br />
‘Other children’ age groups. When interpreting these MOEs, it should be considered that there is a<br />
remarkable influence of left-censored data (91.3 % of the total data) on the UB estimates since UB<br />
occurrence values were 10-fold higher than LB for the most consumed <strong>water</strong>, i.e. tap <strong>water</strong>. Moreover,<br />
these MOEs were calculated by using as RP the BMDL 10 derived from dose-response analysis of<br />
incidence of tumours (combined incidence of adenomas and carcinomas) in the small intestine of<br />
mice. There is evidence of differences in anatomy and functional properties of the stomach in rodents<br />
and in humans that are expected to impact significantly on the efficiency of Cr(VI) reduction in the GI<br />
tract. Efficient Cr(VI) reduction in the GI tract would reduce chances of cellular uptake and<br />
subsequent induction of genotoxicity/carcinogenicity. In particular, the reduction capacity of rodents<br />
is expected to be significantly lower than that of humans, which makes rodents a worst case model for<br />
human carcinogenicity. When interpreting the numerical value of the MOE it should be considered<br />
that there is a significant uncertainty associated with the use of tumour data in mice to estimate risk at<br />
doses of Cr(VI) relevant for human exposure.<br />
Based on the MOE values for neoplastic effects, the CONTAM Panel concluded that the current levels<br />
of exposure to Cr(VI) via the consumption of <strong>water</strong> intended for human consumption and mineral<br />
<strong>water</strong>s are of low concern from a public health point of view for average consumers but there might be<br />
a potential concern for high consumers particularly for ‘Infants’, ‘Toddlers’ and ‘Other children’.<br />
Table 24: Margin of exposure (MOE) calculated across the different European dietary surveys for<br />
Cr(VI) through the consumption of <strong>drinking</strong> <strong>water</strong> (<strong>water</strong> intended for human consumption and<br />
mineral <strong>water</strong>s) as such. MOEs are rounded to two significant digits.<br />
MOE (min LBmax<br />
UB)<br />
Mean exposure (a)<br />
Dietary surveys<br />
with MOE below<br />
10 000/Total<br />
surveys (b)<br />
95 th percentile exposure (a)<br />
MOE (min LB-max<br />
UB)<br />
Dietary surveys with<br />
MOE below<br />
10 000/Total<br />
surveys (b)<br />
Infants (c) 71 000 - 6300 2/2 21 000 - 3100 1/1<br />
Toddlers 130 000 - 11 000 0/9 62 000 - 4200 6/6<br />
Other children 1 400 000 - 16 000 0/15 360 000 - 6600 9/15<br />
Adolescents 1 200 000 - 23 000 0/10 350 000 - 9100 1/10<br />
Adults 710 000 - 23 000 0/13 230 000 - 9200 1/13<br />
Elderly 540 000 - 29 000 0/6 210 000 - 11 000 0/6<br />
Very elderly 740 000 - 29 000 0/4 95 000 - 11 000 0/3<br />
(a): Dietary surveys with less than 50 % consumers were not considered (surveys from Greece (age class ‘Other children’),<br />
Cyprus (age class ‘Adolescents’), Latvia (age classes ‘Other children’, ‘Adolescents’ and ‘Adults’) and Hungary (age<br />
classes ‘Adults’, ‘Elderly’ and ‘Very elderly’, see Table G2 in appendix);<br />
(b): Number of surveys with a MOE lower than 10000 at the UB;<br />
(c): Estimate only available from two dietary surveys for the mean and only one for the 95 th percentiles;<br />
The highest chronic exposure to Cr(VI) through the consumption of bottled <strong>water</strong> was estimated in the<br />
youngest population (‘Infants’ and ‘Toddlers’) (Table 10). Due to the lack of consumption data on<br />
bottled <strong>water</strong>, in several dietary surveys no exposure to Cr(VI) through the consumption of bottled<br />
EFSA Journal 2014;12(3):3595 116