efsa-opinion-chromium-food-drinking-water

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

damienvanherp
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16.04.2014 Views

Chromium in food and drinking water haematological effects the current exposure levels to Cr(VI) via drinking water are of no concern from a public health point of view. 9. Uncertainty analysis The evaluation of the inherent uncertainties in the assessment of exposure to chromium, in particular to Cr(III) in food and to Cr(VI) in drinking water, has been performed following the guidance of the Opinion of the Scientific Committee related to Uncertainties in Dietary Exposure Assessment (EFSA, 2006). In addition, the report on ‘Characterizing and Communicating Uncertainty in Exposure Assessment’ has been considered (WHO-IPCS, 2008). According to the guidance provided by the EFSA opinion (2006), the following sources of uncertainties have been considered: assessment objectives, exposure scenario, exposure model, and model input (parameters). 9.1. Assessment objectives The objectives of the assessment were clearly specified in the terms of reference. 9.2. Exposure scenario/Exposure model In response to EFSAs request to submit occurrence data on chromium in food and water intended for human consumption and natural mineral waters, 79 809 analytical results were available in the EFSA data base among them about 65 % for drinking water. The samples were collected mostly (80 %) by one Member State. Around 50 % of the analytical results for food and 90 % for water were leftcensored. All food groups were well represented with around 17 % belonging to the group of ‘Vegetables and vegetable products (including fungi)’. The majority of the water samples belonged to the type of tap water (60.6 %). There is an uncertainty in possible regional differences in the presence of chromium in food commodities and types of waters and it is evident that the dataset is not fully representative for all Member States. Highest chromium concentrations in food (assumed to be all Cr (III)) were reported for specific foods such as ‘Products for special nutritional use’, ‘Herbs, spices and condiments’ and ‘Sugar and confectionary’. The concentration data in water ranged within one order of magnitude. However, the CONTAM Panel noted different reported consumption data for water intended for human consumption and natural mineral waters across Europe, such that the variation of the exposure to chromium (all assumed to be Cr(VI)) through the consumption of water was considerably high. The majority (99.9 %) of the analytical results were reported to EFSA as total chromium or as chromium without specification (only 88 analytical results were received on Cr(VI), all in bottled water). No data on speciation of Cr in food were provided in the occurrence dataset and this adds to the uncertainty of exposure assessment of both Cr(III) and Cr(VI) in food. The CONTAM Panel’s assumption that all reported analytical results in food related to Cr(III) was based on information on the reducing capacity of the organic food components, and the fact that Cr(III) is the most stable oxidation state. This assumption adds to uncertainty in particular with respect to the exposure assessment of Cr(VI), since 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 levels. The CONTAM Panel noted that in the analysed water samples the average ratio Cr(VI)/total Cr was almost equal to one, and that drinking water is usually treated with oxidizing agents to make it potable, which would promote the presence of Cr(VI) instead of Cr(III). Therefore, the CONTAM Panel decided to consider all Cr present in drinking water as Cr(VI). This approach adds to the uncertainty of exposure assessment since the chemical analyses of Cr(VI) was performed in a very limited number of samples. Despite the assumption that the presence of Cr(VI) in food is unlikely, exposure scenarios considering the additional contribution of the Cr(VI) present in the water used to prepare certain foods (tea infusions, coffee, and infant and follow-on food, mainly, but also some others such as instant soup, evaporated and dried milk, and dehydrated fruit juice) were evaluated. These scenarios are highly conservative since it is assumed that all Cr(VI) remains oxidized before the ingestion of the foods. EFSA Journal 2014;12(3):3595 118

Chromium in food and drinking water Food preparation using stainless steel containers, processors and utensils may add Cr(III) to the presence of chromium in food. As data on food as consumed are practically not present in the dataset applied, this could have led to a potential underestimation of the exposure to Cr(III) in food. A large proportion of samples with left-censored data introduced considerable uncertainties to the overall dietary exposure estimate, particularly for drinking water. Therefore the LB values reported in this opinion tend to underestimate, while UB tends to overestimate the dietary exposure. The limited data on both consumption and occurrence data on human milk led to use a simulated scenario to estimate the exposure to Cr(III) in infants exclusively fed with human milk. This adds uncertainty to the estimated contribution of human milk to the exposure to Cr(III). There is uncertainty associated to the dietary exposure calculated for the vegetarian population since very limited consumption data are available. The lack of appropriate consumption data on fortified foods, foodstuffs for particular nutritional use (PARNUTS) and food supplements obliged to the use of a simulated scenario that adds uncertainty to the contribution of these products to the exposure to Cr(III). There are also insufficient data on consumption for children younger than one year (infants), which adds uncertainty to the exposure calculations in this age group. Overall, there is considerable uncertainty regarding the total dietary exposure to chromium from food and water intended for human consumption and mineral waters. 9.3. Model input (parameters) Standardized methods exist for the determination of total chromium in food and in water. For Cr(VI) in water, standardised methods exist, however, no validated or standardised method for speciation of chromium in food is available. Limited standard or certified reference materials are available for chromium species. Regular proficiency testing is organised for total chromium in foodstuffs and water, and only proficiency testing for Cr(VI) in water exists. The analytical results used for exposure assessment were performed by different laboratories at largely varying LOQ/LODs. Those limitations may have added to the overall uncertainty of the analytical results. 9.4. Other uncertainties Toxicity of trivalent chromium The CONTAM Panel considered it appropriate to establish a TDI Cr(III) based on the NOAEL of a 2-year NTP study in rats (NTP, 2010) where no adverse effects were observed even at the highest dose tested. Due to the uncertainty in the available data on developmental and reproduction toxicity, the CONTAM applied an uncertainty factor of 10 in addition to the default uncertainty factor of 100 for the extrapolations from rodents to humans and for human variability. Toxicity of hexavalent chromium Cr (VI) has been classified by IARC as being carcinogenic to humans (group 1) and was identified by the CONTAM Panel as genotoxic and carcinogenic. An MOE approach was applied, based on the combined incidence of adenomas and carcinomas in the small intestine from a 2-year study in mice (NTP, 2008). The CONTAM Panel noted that the BMDL 10 and resulting MOEs would be 3.8 times higher if based on carcinoma incidence only. Observations in humans showed toxicity of chromium at very high doses resulting after accidental and intended intoxications. Epidemiological data on dietary exposure were negative or inconclusive. Given that the CONTAM Panel used the rodent tumour data and the MOE approach for the risk assessment of Cr(VI), uncertainty exists on whether the MOE of 10 000 adequately accounts for possible differences in the level of reduction of Cr(VI) in GI tract in humans as compared to rodents. Uncertainty exists on the impact of the competing processes of reduction and absorption of ingested EFSA Journal 2014;12(3):3595 119

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

Food preparation using stainless steel containers, processors and utensils may add Cr(III) to the<br />

presence of <strong>chromium</strong> in <strong>food</strong>. As data on <strong>food</strong> as consumed are practically not present in the dataset<br />

applied, this could have led to a potential underestimation of the exposure to Cr(III) in <strong>food</strong>.<br />

A large proportion of samples with left-censored data introduced considerable uncertainties to the<br />

overall dietary exposure estimate, particularly for <strong>drinking</strong> <strong>water</strong>. Therefore the LB values reported in<br />

this <strong>opinion</strong> tend to underestimate, while UB tends to overestimate the dietary exposure.<br />

The limited data on both consumption and occurrence data on human milk led to use a simulated<br />

scenario to estimate the exposure to Cr(III) in infants exclusively fed with human milk. This adds<br />

uncertainty to the estimated contribution of human milk to the exposure to Cr(III). There is uncertainty<br />

associated to the dietary exposure calculated for the vegetarian population since very limited<br />

consumption data are available.<br />

The lack of appropriate consumption data on fortified <strong>food</strong>s, <strong>food</strong>stuffs for particular nutritional use<br />

(PARNUTS) and <strong>food</strong> supplements obliged to the use of a simulated scenario that adds uncertainty to<br />

the contribution of these products to the exposure to Cr(III).<br />

There are also insufficient data on consumption for children younger than one year (infants), which<br />

adds uncertainty to the exposure calculations in this age group.<br />

Overall, there is considerable uncertainty regarding the total dietary exposure to <strong>chromium</strong> from <strong>food</strong><br />

and <strong>water</strong> intended for human consumption and mineral <strong>water</strong>s.<br />

9.3. Model input (parameters)<br />

Standardized methods exist for the determination of total <strong>chromium</strong> in <strong>food</strong> and in <strong>water</strong>. For Cr(VI)<br />

in <strong>water</strong>, standardised methods exist, however, no validated or standardised method for speciation of<br />

<strong>chromium</strong> in <strong>food</strong> is available. Limited standard or certified reference materials are available for<br />

<strong>chromium</strong> species. Regular proficiency testing is organised for total <strong>chromium</strong> in <strong>food</strong>stuffs and<br />

<strong>water</strong>, and only proficiency testing for Cr(VI) in <strong>water</strong> exists. The analytical results used for exposure<br />

assessment were performed by different laboratories at largely varying LOQ/LODs. Those limitations<br />

may have added to the overall uncertainty of the analytical results.<br />

9.4. Other uncertainties<br />

Toxicity of trivalent <strong>chromium</strong><br />

The CONTAM Panel considered it appropriate to establish a TDI Cr(III) based on the NOAEL of a<br />

2-year NTP study in rats (NTP, 2010) where no adverse effects were observed even at the highest dose<br />

tested. Due to the uncertainty in the available data on developmental and reproduction toxicity, the<br />

CONTAM applied an uncertainty factor of 10 in addition to the default uncertainty factor of 100 for<br />

the extrapolations from rodents to humans and for human variability.<br />

Toxicity of hexavalent <strong>chromium</strong><br />

Cr (VI) has been classified by IARC as being carcinogenic to humans (group 1) and was identified by<br />

the CONTAM Panel as genotoxic and carcinogenic. An MOE approach was applied, based on the<br />

combined incidence of adenomas and carcinomas in the small intestine from a 2-year study in mice<br />

(NTP, 2008). The CONTAM Panel noted that the BMDL 10 and resulting MOEs would be 3.8 times<br />

higher if based on carcinoma incidence only.<br />

Observations in humans showed toxicity of <strong>chromium</strong> at very high doses resulting after accidental and<br />

intended intoxications. Epidemiological data on dietary exposure were negative or inconclusive.<br />

Given that the CONTAM Panel used the rodent tumour data and the MOE approach for the risk<br />

assessment of Cr(VI), uncertainty exists on whether the MOE of 10 000 adequately accounts for<br />

possible differences in the level of reduction of Cr(VI) in GI tract in humans as compared to rodents.<br />

Uncertainty exists on the impact of the competing processes of reduction and absorption of ingested<br />

EFSA Journal 2014;12(3):3595 119

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