efsa-opinion-chromium-food-drinking-water

efsa-opinion-chromium-food-drinking-water efsa-opinion-chromium-food-drinking-water

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Chromium in food and drinking water SUMMARY In March 2012, the European Food Safety Authority (EFSA) received a request from the Hellenic Food Authority (EFET) for a scientific opinion on estimation of the risk to human health from the presence of chromium (Cr) in food and Cr(VI) in bottled water. Chromium is a metal widely distributed in the environment occurring in rocks, soil and volcanic dust and gases. Chromium can exist in a variety of oxidation states, with the trivalent (Cr(III)) and hexavalent (Cr(VI)) states being relatively stable and largely predominant. While Cr(III) is a natural dietary constituent present in a variety of foods and also in dietary supplements, Cr(VI) most commonly occurs in industrial processes and is present in drinking water usually as a consequence of anthropogenic contamination. At human dietary exposure levels chromium absorption is relatively low (< 10 % of the ingested dose) and depends on its valence state and ligands. Most of the ingested Cr(VI) is considered to be reduced in the stomach to Cr(III), which is poorly bioavailable and presents low ability to enter cells. In contrast to Cr(III), Cr(VI) is able to cross cellular membranes. The interconversion of Cr(VI) to Cr(III) is of relevance for risk assessment since, in general, Cr(VI) compounds are much more toxic than Cr(III) compounds. There are no maximum levels (MLs) for chromium in food. A parametric value of 50 μg Cr/L for total chromium in water intended for human consumption and a Maximum Limit of 50 μg Cr/L for total chromium in natural mineral waters are laid down in Council Directive 98/83/EC and in Commission Directive 2003/40/EC, respectively. The International Agency for Research on Cancer (IARC) has classified Cr(VI) compounds as carcinogenic to humans (Group 1) with respect to the cancer of the lung and also cancer of the nose and nasal sinuses based on evidence from occupational studies. Following a call for data on chromium (trivalent and hexavalent) levels in food and drinking water (water intended for human consumption and mineral waters), a total of 79 809 analytical results on chromium were available in the EFSA database by the end of February 2013. A total of 27 074 analytical results were reported for food and 52 735 for all types of drinking water (including e.g. tap water, bottled water and well water) covering the period from 2000 to 2012. Data were mainly from 1 Member State although 11 other European countries were represented. Information on oxidation state was not available for occurrence data in food, and for drinking water only 88 analytical results were received on Cr(VI), all in bottled water. Almost 50 % of the results on food samples were left-censored. After data cleaning and validation and using different cut-offs based on the reported limits of quantification (LOQs), 24 629 analytical results for food were considered for this assessment. At FoodEx level 1 all the food groups were well represented, with a maximum of 4 647 samples in the food group ‘Vegetables and vegetable products (including fungi)’. The five food groups of highest average chromium occurrence values were ‘Products for special nutritional use’, ‘Herbs, spices and condiments’, ‘Sugar and confectionary’, ‘Vegetables and vegetable products (including fungi)’, and ‘Animal and vegetable fats and oils’. There is a lack of data on the presence of Cr(VI) in food. The EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) decided to consider all the reported analytical results in food as Cr(III). This assumption was based on the outcome of recent speciation work, the fact that food is by-andlarge a reducing medium, and that oxidation of Cr(III) to Cr(VI) would not be favoured in such a medium. However, the CONTAM Panel noted that if even a small proportion of total chromium in food was in the form of Cr(VI), it could contribute substantially to Cr(VI) exposure. Chronic dietary exposure to Cr(III) was estimated combining the food mean occurrence data with the food consumption data at the individual level. Following the standard representation used for CONTAM opinions, lower bound (LB) and upper bound (UB) mean chronic dietary exposure values were calculated for Cr(III), across the different dietary surveys and age classes. Overall mean human chronic dietary exposure ranged from a minimum LB of 0.6 to a maximum UB of 5.9 μg/kg b.w. per EFSA Journal 2014;12(3):3595 2

Chromium in food and drinking water day. The 95 th percentile dietary exposure values ranged from 1.1 (minimum LB) to 9.0 (maximum UB) μg/kg b.w. per day. Among the different age classes, ‘Toddlers’ showed the highest mean chronic dietary exposure to Cr(III) with minimum LB of 2.3 and maximum UB of 5.9 μg/kg b.w. per day. The adult populations (‘Adult’, ‘Elderly’ and ‘Very elderly’) showed lower exposure to Cr(III) than the younger populations. The mean chronic dietary exposure to Cr(III) varied between 0.6 µg/kg b.w. per day and 1.6 µg/kg b.w. per day (minimum LB and maximum UB, adults in both cases). The 95 th percentile chronic dietary exposure ranged from 1.1 μg/kg b.w. per day (minimum LB, ‘Elderly’) and 2.6 μg/kg b.w. per day (maximum UB, adults). In ‘Infants’ and ‘Toddlers’ the main contributors to the chronic exposure to Cr(III) were ‘Foods for infants and small children’, followed by ‘Milk and dairy products’ and ‘Bread and rolls’. In the other age classes, the main contributors to the chronic exposure to Cr(III) were the food categories ‘Milk and dairy products, ‘Bread and rolls’, ‘Chocolate (cocoa) products’ (except for ‘Elderly’ and ‘Very elderly’ population) and ‘Non-alcoholic beverages’. The food group ‘Vegetables and vegetable products (including fungi)’ contributed to the exposure to Cr(III) with median values that ranged from 4 % in ‘Adolescents’ and ‘Other children’, to 8 % in the ‘Elderly’ population. The assessment of the dietary exposure to Cr(III) in vegetarians was based on very limited data. The results indicated that virtually the same mean and 95 th dietary exposure are likely in the vegetarian population as compared to the general population. Overall, the Comprehensive Database contains limited information on the consumption of fortified foods, foodstuffs for particular nutritional use (PARNUTS) and food supplements. Based on previous EFSA opinions, 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.). In the FoodEx classification system, the different types of water are grouped under the generic name ‘Drinking water’. Therefore, the generic term drinking water as used in this opinion includes both categories defined by the EU legislation, i.e. water intended for human consumption and natural mineral waters. Bottled water as used in this opinion includes natural mineral water, but also spring water and other bottled drinking waters, products that must comply with Council Directive 98/83/EC. More than 90 % of the results for all types of drinking water were left-censored. Concerning the data on bottled water, 11 % of the samples analysed both for Cr(VI) and total chromium reported no quantified values for both parameters. After data cleaning and validation, and applying a cut-off value of 10 μg/L on the LOQs reported for total chromium, a total of 46 234 analytical results on water (including 88 results on Cr(VI)) were selected for exposure calculations. Tap water samples were the most reported (61 %) with LB and UB mean occurrence values of 0.2 µg/L and 1.9 µg/L, respectively. In bottled water, the mean occurrence values ranged between 0.3 µg/L for carbonated mineral water (LB) and 3.4 µg/L at the UB reported for unspecified bottled water. The CONTAM Panel assumed that all chromium present in drinking water was Cr(VI) (worst case scenario) based on two reasons. First, the samples where both Cr(VI) and total chromium were quantified (71 out of 88 samples) showed an average ratio Cr(VI)/total chromium of 0.97. In addition the water intended for human consumption is usually treated with different oxidizing agents to make it potable, and this would promote the presence of Cr(VI) over that of Cr(III). The CONTAM Panel estimated separately the exposure to Cr(VI) in all types of drinking water and in bottled water. The mean chronic exposure to Cr(VI) from consumption of all types of drinking water ranged from 0.7 (minimum LB) to 159.1 ng/kg b.w. per day (maximum UB). The 95 th percentile exposure ranged from 2.8 (minimum LB) to 320.2 (maximum UB) ng/kg b.w. per day. The highest exposure to Cr(VI) through the consumption of all types of drinking water was estimated in the youngest populations (‘Infants’ and ‘Toddlers’). No consumption of bottled water was reported in several dietary surveys. In those dietary surveys with reported data on consumption of bottled water, the highest exposure to Cr(VI) was also estimated in the youngest populations (‘Infants’ and ‘Toddlers’), with a mean chronic exposure ranging from < 0.1 (minimum LB) to EFSA Journal 2014;12(3):3595 3

Chromium in <strong>food</strong> and <strong>drinking</strong> <strong>water</strong><br />

SUMMARY<br />

In March 2012, the European Food Safety Authority (EFSA) received a request from the Hellenic<br />

Food Authority (EFET) for a scientific <strong>opinion</strong> on estimation of the risk to human health from the<br />

presence of <strong>chromium</strong> (Cr) in <strong>food</strong> and Cr(VI) in bottled <strong>water</strong>.<br />

Chromium is a metal widely distributed in the environment occurring in rocks, soil and volcanic dust<br />

and gases. Chromium can exist in a variety of oxidation states, with the trivalent (Cr(III)) and<br />

hexavalent (Cr(VI)) states being relatively stable and largely predominant. While Cr(III) is a natural<br />

dietary constituent present in a variety of <strong>food</strong>s and also in dietary supplements, Cr(VI) most<br />

commonly occurs in industrial processes and is present in <strong>drinking</strong> <strong>water</strong> usually as a consequence of<br />

anthropogenic contamination.<br />

At human dietary exposure levels <strong>chromium</strong> absorption is relatively low (< 10 % of the ingested dose)<br />

and depends on its valence state and ligands. Most of the ingested Cr(VI) is considered to be reduced<br />

in the stomach to Cr(III), which is poorly bioavailable and presents low ability to enter cells. In<br />

contrast to Cr(III), Cr(VI) is able to cross cellular membranes. The interconversion of Cr(VI) to Cr(III)<br />

is of relevance for risk assessment since, in general, Cr(VI) compounds are much more toxic than<br />

Cr(III) compounds.<br />

There are no maximum levels (MLs) for <strong>chromium</strong> in <strong>food</strong>. A parametric value of 50 μg Cr/L for total<br />

<strong>chromium</strong> in <strong>water</strong> intended for human consumption and a Maximum Limit of 50 μg Cr/L for total<br />

<strong>chromium</strong> in natural mineral <strong>water</strong>s are laid down in Council Directive 98/83/EC and in Commission<br />

Directive 2003/40/EC, respectively.<br />

The International Agency for Research on Cancer (IARC) has classified Cr(VI) compounds as<br />

carcinogenic to humans (Group 1) with respect to the cancer of the lung and also cancer of the nose<br />

and nasal sinuses based on evidence from occupational studies.<br />

Following a call for data on <strong>chromium</strong> (trivalent and hexavalent) levels in <strong>food</strong> and <strong>drinking</strong> <strong>water</strong><br />

(<strong>water</strong> intended for human consumption and mineral <strong>water</strong>s), a total of 79 809 analytical results on<br />

<strong>chromium</strong> were available in the EFSA database by the end of February 2013. A total of<br />

27 074 analytical results were reported for <strong>food</strong> and 52 735 for all types of <strong>drinking</strong> <strong>water</strong> (including<br />

e.g. tap <strong>water</strong>, bottled <strong>water</strong> and well <strong>water</strong>) covering the period from 2000 to 2012. Data were mainly<br />

from 1 Member State although 11 other European countries were represented. Information on<br />

oxidation state was not available for occurrence data in <strong>food</strong>, and for <strong>drinking</strong> <strong>water</strong> only 88 analytical<br />

results were received on Cr(VI), all in bottled <strong>water</strong>.<br />

Almost 50 % of the results on <strong>food</strong> samples were left-censored. After data cleaning and validation and<br />

using different cut-offs based on the reported limits of quantification (LOQs), 24 629 analytical results<br />

for <strong>food</strong> were considered for this assessment. At FoodEx level 1 all the <strong>food</strong> groups were well<br />

represented, with a maximum of 4 647 samples in the <strong>food</strong> group ‘Vegetables and vegetable products<br />

(including fungi)’. The five <strong>food</strong> groups of highest average <strong>chromium</strong> occurrence values were<br />

‘Products for special nutritional use’, ‘Herbs, spices and condiments’, ‘Sugar and confectionary’,<br />

‘Vegetables and vegetable products (including fungi)’, and ‘Animal and vegetable fats and oils’.<br />

There is a lack of data on the presence of Cr(VI) in <strong>food</strong>. The EFSA Panel on Contaminants in the<br />

Food Chain (CONTAM Panel) decided to consider all the reported analytical results in <strong>food</strong> as Cr(III).<br />

This assumption was based on the outcome of recent speciation work, the fact that <strong>food</strong> is by-andlarge<br />

a reducing medium, and that oxidation of Cr(III) to Cr(VI) would not be favoured in such a<br />

medium.<br />

However, the CONTAM Panel noted that if even a small proportion of total <strong>chromium</strong> in <strong>food</strong> was in<br />

the form of Cr(VI), it could contribute substantially to Cr(VI) exposure.<br />

Chronic dietary exposure to Cr(III) was estimated combining the <strong>food</strong> mean occurrence data with the<br />

<strong>food</strong> consumption data at the individual level. Following the standard representation used for<br />

CONTAM <strong>opinion</strong>s, lower bound (LB) and upper bound (UB) mean chronic dietary exposure values<br />

were calculated for Cr(III), across the different dietary surveys and age classes. Overall mean human<br />

chronic dietary exposure ranged from a minimum LB of 0.6 to a maximum UB of 5.9 μg/kg b.w. per<br />

EFSA Journal 2014;12(3):3595 2

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