efsa-opinion-chromium-food-drinking-water

Chromium in food and drinking water
For the incidence of diffuse epithelial hyperplasia in the duodenum in male mice the BMDL 10
value of 0.11 mg Cr(VI)/kg b.w. per day was calculated.
The CONTAM Panel identified haematocrit, haemoglobin, MCV and MVH values measured
in male rats at day 22 after start of treatment as critical endpoints for haematological effects
of Cr(VI) and suitable for a BMD analysis. The lowest BMDL 05 of 0.2 mg Cr(VI)/kg b.w. per
day was calculated for decreased hematocrit in male rats.
Derivation of Health-based Guidance Values/Margin of exposure approach
Trivalent chromium
The Panel derived a TDI of 300 µg Cr(III)/kg b.w. per day from the relevant NOAEL of
286 mg/kg b.w. per day identified in a long-term rat study, applying the default uncertainty
factor of 100 to account for species differences and human variability, and an additional
uncertainty factor 10 to account for the absence of adequate data on reproductive and
developmental toxicity.
Hexavalent chromium
Since the adenoma-carcinoma sequence is a well recognised pathway of carcinogenesis in the
GI tract, in a conservative approach, the CONTAM Panel selected the BMDL 10 of 1.0 mg
Cr(VI)/kg b.w. per day for combined adenomas or carcinomas of the small intestine in male
and female mice as the reference point for the estimation of the MOE for neoplastic changes.
From the analysis of non-neoplastic lesions in experimental animals, the CONTAM Panel
selected the lowest BMDL 10 value of 0.11 mg Cr(VI)/kg b.w. per day for diffuse epithelial
hyperplasia of the duodenum in female mice as the reference point for the estimation of the
MOE for non-neoplastic lesions.
From the analysis of haematological effects in rats, the CONTAM Panel selected the lowest
BMDL 05 of 0.2 mg/kg b.w. per day for decrease of haematocrit in male rats. This value was
used as the reference point for the MOE estimation of haematotoxic effects.
Risk characterisation
Trivalent chromium
The mean dietary exposure across all age groups (minimum LB of 0.6 μg/kg b.w. per day and
maximum UB of 5.9 μg/kg b.w. per day) as well as the 95 th percentile exposure (minimum
LB of 1.1 μg/kg b.w. per day and maximum UB of 9.0 μg/kg b.w. per day) are well below the
TDI of 300 µg Cr(III)/ kg b.w. per day.
Although based on limited consumption data, the dietary exposure to Cr(III) of the vegetarian
population seems to be similar to that estimated for the general population. Therefore, the
dietary exposure of vegeterians is well below the TDI of 300 µg Cr(III)/kg b.w. per day.
The combined exposure from supplemental intake in adults (i.e. from fortified foods,
PARNUTS and food supplements) would be between 910 µg/day for a typical intake and
1540 µg/day for upper intake (13 µg/kg b.w. per day and 22 µg/kg b.w. per day, respectively
for an adult of 70 kg b.w.). Considering this exposure and the maximum estimated
contribution coming from the diet for adults (95 th percentile of 2.6 µg/kg b.w. per day), the
total exposure is well below the TDI of 300 µg Cr(III)/kg b.w. per day.
EFSA Journal 2014;12(3):3595 126