efsa-opinion-chromium-food-drinking-water
efsa-opinion-chromium-food-drinking-water
efsa-opinion-chromium-food-drinking-water
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Chromium in <strong>food</strong> and <strong>drinking</strong> <strong>water</strong><br />
The current dietary exposure to Cr(III) does not raise concerns from a public health point of<br />
view.<br />
Hexavalent <strong>chromium</strong><br />
As recommended for substances which are both genotoxic and carcinogenic, the CONTAM<br />
Panel adopted the MOE approach for the risk characterisation of neoplastic effects of Cr(VI),<br />
by using the BMDL 10 of 1.0 mg Cr(VI)/kg b.w. per day for the combined incidence of<br />
adenomas and carcinomas in the mouse small intestine as RP.<br />
The EFSA Scientific Committee has concluded that for substances that are both genotoxic and<br />
carcinogenic, an MOE of 10 000 or higher, based on a BMDL 10 from an animal study, is of<br />
low concern from a public health point of view.<br />
The MOEs calculated for all age groups on the basis of the mean chronic exposure to Cr(VI)<br />
via consumption of <strong>drinking</strong> <strong>water</strong> indicate low concern (MOE values > 10 000) for all age<br />
groups with the exception of infants at UB exposure estimates (maximum UB - minimum LB,<br />
6 300 - 71 000).<br />
When considering the 95 th percentile exposure, MOE values below 10 000 were found at UB<br />
exposure estimates, particularly for ‘Infants’ (maximum UB - minimum LB, 3 100 - 21 000),<br />
‘Toddlers’ (maximum UB - minimum LB, 4200 - 62 000), and ‘Other children’ (maximum<br />
UB - minimum LB, 6 600 - 360 000).<br />
Similarly to the risk characterisation carried out for all <strong>drinking</strong> <strong>water</strong>, in the case of exposure<br />
to Cr(VI) through the consumption of bottled <strong>water</strong> MOEs values below 10 000 were mainly<br />
found at UB estimates when considering the 95 th percentile exposure in the youngest<br />
populations (‘Infants’, ‘Toddlers’ and ‘Other children’).<br />
The CONTAM Panel noted that the MOE values calculated for exposure to Cr(VI) via<br />
consumption of all types of <strong>drinking</strong> <strong>water</strong>, as well as only bottled <strong>water</strong> were highly<br />
influenced by the high proportion of left-censored data.<br />
In addition, when interpreting the numerical values of the MOEs, it should be considered that<br />
they were calculated by using as RP the BMDL 10 for the combined incidence of adenomas<br />
and carcinomas in the mouse small intestine. Because of lack of in vivo data on the capacity<br />
and rate of reduction of Cr(VI) in the rodent and human gastrointestinal tract, there is a<br />
significant uncertainty associated with the use of tumour data in mice to estimate risk at doses<br />
of Cr(VI) relevant for human exposure.<br />
Based on the MOE values for neoplastic effects, the CONTAM Panel concluded that the<br />
current levels of exposure to Cr(VI) via the consumption of all types of <strong>water</strong> or of bottled<br />
<strong>water</strong> only are of low concern from a public health point of view for the average consumers<br />
but there might be a potential concern for high consumers particularly in ‘Infants’, ‘Toddlers’<br />
and ‘Other children’.<br />
The inclusion of the <strong>water</strong> used in the preparation of specific <strong>food</strong>s (coffee, tea infusions, and<br />
infant dry and follow-on <strong>food</strong> mainly, but also some others such as instant soup, evaporated<br />
and dried milk, and dehydrated fruit juice) led to an increase up to two-fold of the exposure to<br />
Cr(VI). However, the CONTAM Panel was not able to consider this additional contribution to<br />
the exposure to Cr(VI) when deriving MOEs since no reliable data to quantify Cr(VI) in <strong>food</strong><br />
exist<br />
The MOEs calculated for non-neoplastic lesions, based on the BMDL 10 of 0.11 mg Cr(VI)/kg<br />
b.w. per day selected as RP, were 690 and 340 when considering the maximum UB for mean<br />
and 95 th percentile chronic exposure, respectively. The MOEs calculated for haematotoxic<br />
effects, based on the BMDL 05 of 0.2 mg/kg b.w. per day selected as RP, were 1 300 and<br />
630 when considering the maximum UB for mean and 95 th percentile chronic exposure,<br />
respectively.<br />
EFSA Journal 2014;12(3):3595 127