efsa-opinion-chromium-food-drinking-water

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

damienvanherp
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Chromium in food and drinking water 7. Hazard identification and characterisation .................................................................................... 62 7.1. Toxicokinetics ....................................................................................................................... 62 7.1.1. Trivalent Chromium ......................................................................................................... 62 7.1.2. Hexavalent chromium ....................................................................................................... 66 7.1.3. Physiologically-based kinetic (PBK) models ................................................................... 69 7.2. Toxicity in experimental animals .......................................................................................... 70 7.2.1. Trivalent chromium .......................................................................................................... 70 7.2.2. Hexavalent chromium ....................................................................................................... 80 7.3. Observations in humans ........................................................................................................ 96 7.3.1. Observations in humans related to Cr(III) ........................................................................ 97 7.3.2. Observations in humans related to Cr(VI) ........................................................................ 97 7.3.3. Other observations in humans ........................................................................................ 101 7.3.4. Biomonitoring ................................................................................................................. 102 7.4. Modes of action................................................................................................................... 102 7.5. Dose-response assessment .................................................................................................. 111 7.5.1. Assessment of neoplastic effects of Cr(VI) .................................................................... 111 7.5.2. Assessment of non-neoplastic effects of Cr(VI) ............................................................. 112 7.6. Derivation of health-based guidance value(s)/margin of exposure ..................................... 114 8. Risk characterisation .................................................................................................................... 115 9. Uncertainty analysis .................................................................................................................... 118 9.1. Assessment objectives ........................................................................................................ 118 9.2. Exposure scenario/Exposure model .................................................................................... 118 9.3. Model input (parameters).................................................................................................... 119 9.4. Other uncertainties .............................................................................................................. 119 9.5. Summary of uncertainties ................................................................................................... 120 Conclusions and recommendations ...................................................................................................... 121 References ............................................................................................................................................ 128 Appendices ........................................................................................................................................... 167 Abbreviations ....................................................................................................................................... 257 EFSA Journal 2014;12(3):3595 8

Chromium in food and drinking water BACKGROUND AS PROVIDED BY THE HELLENIC FOOD AUTHORITY (EFET) Chromium is a steely-gray, hard metal that occurs naturally everywhere in the environment. It can exist in a number of different oxidation states, ranging from - 2 to + 6 but the most stable forms are elemental chromium, trivalent chromium (chromium III) and hexavalent chromium (chromium VI). Chromium is released into the environment by natural processes (mainly dust from rocks and volcanic activity) and, to a greater extent, by human activities (metal industries, burning of oil and coal, waste incineration etc). Due to its strong resistance to corrosion, chromium is commonly used in the production of stainless steel and for surface coating through electroplating. Other uses of chromium include dyes and colour pigments, tanning of leather, wood preservatives and catalysts. The International Agency for Research on Cancer (IARC) has classified chromium VI as carcinogenic to humans (Group 1) while metallic chromium and chromium III compounds were not classifiable as to their carcinogenicity to humans (Group 3) (IARC, 1990) 4 . The occurrence of hexavalent chromium compounds is rare and nearly always man-made. Chromium III is considered to be an essential element both in animal and human nutrition 5 . Exposure to chromium for the general population occurs primarily via food and drinking water, but also through inhalation of ambient air. Cigarette smoking is another important source of chromium exposure. There is presently no EU regulation regarding maximum levels of chromium in food. For water intended for human consumption, a quality standard of 50 µg/L for total chromium is laid down in Council Directive 98/83/EC 6 , but no level is available specifically for chromium VI. In 2011 the Hellenic Food Authority (EFET) monitored the presence of total chromium in food crops and bottled water. In food crops concentrations of up to 0.96 mg/kg total chromium were measured. All the tested samples of bottled water contained total chromium at concentrations lower than the drinking water quality standard of 50 µg/L. However, there is evidence from the surveys carried out in Greece that the concentrations of chromium VI can reach up to 36 µg/L in bottled water. TERMS OF REFERENCE AS PROVIDED BY THE HELLENIC FOOD AUTHORITY (EFET) In accordance with Art 29 (1) of Regulation (EC) No 178/2002, the Hellenic Food Authority asks the European Food Safety Authority to provide a scientific opinion on the risk to human health related to the presence of chromium in food addressing particularly the presence of chromium in vegetables and hexavalent chromium (chromium VI) in bottled water. The scientific opinion should: Consider any relevant information on toxicity of chromium III and chromium VI, considering all relevant toxicological endpoints; Assess the contribution of different foodstuffs to human exposure to total chromium. This should particularly include the contribution of chromium in vegetables and chromium VI in bottled water. An indication of non-dietary sources of exposure (e.g. air, cigarette smoke) should be given. Contain a dietary exposure assessment of chromium taking into account the recent analytical results on the occurrence on chromium III and chromium VI in food and bottled water, and the consumption patterns of specific (vulnerable) groups of the population (e.g. high consumers, children, people following a specific diet, etc). 4 IARC Monograph on the Evaluation of Carcinogenic Risks to Humans (1990). Chromium, Nickel and welding. Volume 49. Available at: http://monographs.iarc.fr/ENG/Monographs/vol49/mono49.pdf. 5 Opinion of the Scientific Committee on Food on the Tolerable Upper Intake Level of Trivalent Chromium (expressed in 4 April 2003). Available at http://ec.europa.eu/food/fs/sc/scf/out197_en.pdf 6 Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption, OJ L 330, 5.12.98, p. 32-54. EFSA Journal 2014;12(3):3595 9

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

BACKGROUND AS PROVIDED BY THE HELLENIC FOOD AUTHORITY (EFET)<br />

Chromium is a steely-gray, hard metal that occurs naturally everywhere in the environment. It can<br />

exist in a number of different oxidation states, ranging from - 2 to + 6 but the most stable forms are<br />

elemental <strong>chromium</strong>, trivalent <strong>chromium</strong> (<strong>chromium</strong> III) and hexavalent <strong>chromium</strong> (<strong>chromium</strong> VI).<br />

Chromium is released into the environment by natural processes (mainly dust from rocks and volcanic<br />

activity) and, to a greater extent, by human activities (metal industries, burning of oil and coal, waste<br />

incineration etc). Due to its strong resistance to corrosion, <strong>chromium</strong> is commonly used in the<br />

production of stainless steel and for surface coating through electroplating. Other uses of <strong>chromium</strong><br />

include dyes and colour pigments, tanning of leather, wood preservatives and catalysts.<br />

The International Agency for Research on Cancer (IARC) has classified <strong>chromium</strong> VI as carcinogenic<br />

to humans (Group 1) while metallic <strong>chromium</strong> and <strong>chromium</strong> III compounds were not classifiable as<br />

to their carcinogenicity to humans (Group 3) (IARC, 1990) 4 . The occurrence of hexavalent <strong>chromium</strong><br />

compounds is rare and nearly always man-made. Chromium III is considered to be an essential<br />

element both in animal and human nutrition 5 .<br />

Exposure to <strong>chromium</strong> for the general population occurs primarily via <strong>food</strong> and <strong>drinking</strong> <strong>water</strong>, but<br />

also through inhalation of ambient air. Cigarette smoking is another important source of <strong>chromium</strong><br />

exposure.<br />

There is presently no EU regulation regarding maximum levels of <strong>chromium</strong> in <strong>food</strong>. For <strong>water</strong><br />

intended for human consumption, a quality standard of 50 µg/L for total <strong>chromium</strong> is laid down in<br />

Council Directive 98/83/EC 6 , but no level is available specifically for <strong>chromium</strong> VI.<br />

In 2011 the Hellenic Food Authority (EFET) monitored the presence of total <strong>chromium</strong> in <strong>food</strong> crops<br />

and bottled <strong>water</strong>. In <strong>food</strong> crops concentrations of up to 0.96 mg/kg total <strong>chromium</strong> were measured.<br />

All the tested samples of bottled <strong>water</strong> contained total <strong>chromium</strong> at concentrations lower than the<br />

<strong>drinking</strong> <strong>water</strong> quality standard of 50 µg/L. However, there is evidence from the surveys carried out in<br />

Greece that the concentrations of <strong>chromium</strong> VI can reach up to 36 µg/L in bottled <strong>water</strong>.<br />

TERMS OF REFERENCE AS PROVIDED BY THE HELLENIC FOOD AUTHORITY (EFET)<br />

In accordance with Art 29 (1) of Regulation (EC) No 178/2002, the Hellenic Food Authority asks the<br />

European Food Safety Authority to provide a scientific <strong>opinion</strong> on the risk to human health related to<br />

the presence of <strong>chromium</strong> in <strong>food</strong> addressing particularly the presence of <strong>chromium</strong> in vegetables and<br />

hexavalent <strong>chromium</strong> (<strong>chromium</strong> VI) in bottled <strong>water</strong>.<br />

The scientific <strong>opinion</strong> should:<br />

<br />

<br />

<br />

Consider any relevant information on toxicity of <strong>chromium</strong> III and <strong>chromium</strong> VI, considering<br />

all relevant toxicological endpoints;<br />

Assess the contribution of different <strong>food</strong>stuffs to human exposure to total <strong>chromium</strong>. This<br />

should particularly include the contribution of <strong>chromium</strong> in vegetables and <strong>chromium</strong> VI in<br />

bottled <strong>water</strong>. An indication of non-dietary sources of exposure (e.g. air, cigarette smoke)<br />

should be given.<br />

Contain a dietary exposure assessment of <strong>chromium</strong> taking into account the recent analytical<br />

results on the occurrence on <strong>chromium</strong> III and <strong>chromium</strong> VI in <strong>food</strong> and bottled <strong>water</strong>, and the<br />

consumption patterns of specific (vulnerable) groups of the population (e.g. high consumers,<br />

children, people following a specific diet, etc).<br />

4 IARC Monograph on the Evaluation of Carcinogenic Risks to Humans (1990). Chromium, Nickel and welding.<br />

Volume 49. Available at: http://monographs.iarc.fr/ENG/Monographs/vol49/mono49.pdf.<br />

5 Opinion of the Scientific Committee on Food on the Tolerable Upper Intake Level of Trivalent Chromium (expressed in<br />

4 April 2003). Available at http://ec.europa.eu/<strong>food</strong>/fs/sc/scf/out197_en.pdf<br />

6 Council Directive 98/83/EC of 3 November 1998 on the quality of <strong>water</strong> intended for human consumption, OJ L 330,<br />

5.12.98, p. 32-54.<br />

EFSA Journal 2014;12(3):3595 9

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