efsa-opinion-chromium-food-drinking-water

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Chromium in food and drinking water in food supplements could amount to intake levels of 600 g chromium per day that was well above the levels considered safe by the World Health Organization (WHO) for supplemental intake (i.e. 250 g per day) (WHO, 1996b). The Panel indicated that although the amount of picolinate that would be consumed as a result of the proposed uses (4300 g per day) would be safe, it could not be concluded that the use of Cr(III) picolinate was of no safety concern. It was also noted that there were diverging views and conclusions on the genotoxicity of Cr(III) and therefore its safety needed to be reevaluated. The EFSA evaluated the safety of chromium picolinate as a source of chromium added for nutritional purposes to foodstuff in 2010 (EFSA ANS Panel, 2010a). The ANS Panel noted that the genotoxicity studies suggested that in vitro at high concentrations chromium picolinate might cause DNA damage. Long-term carcinogenicity studies provided equivocal or no evidence of carcinogenic activity of chromium picolinate (Stout et al., 2009; NTP, 2010). The Panel noted that the margin of safety between the No-Observed-Adverse-Effect Level (NOAEL) of 2400 mg/kg b.w. per day chromium picolinate, resulting from the National Toxicology Programme (NTP) long-term study, equivalent to 2100 mg/kg b.w. per day picolinate, would amount to at least 4 orders of magnitude assuming a combined intake of picolinate from all sources. The ANS Panel concluded that the use of Cr(III) picolinate as a source of chromium would not be of concern provided that the amount of chromium does not exceed 250 g/day as established by WHO for supplemental intake of chromium that should not be exceeded. The EFSA evaluated the safety of trivalent chromium as a nutrient added for nutritional purposes to foodstuffs in 2010 (EFSA ANS Panel, 2010b). On the basis of the analysis of in vivo genotoxicity assays and long-term carcinogenicity studies, the ANS Panel concluded that the safety of Cr(III) as a nutrient added to foodstuffs is not of concern, provided that the intake of Cr(III) from these sources does not exceed 250 μg/day, which is the value established by the WHO for supplemental intake of chromium. In 2012, the ANS Panel assessed the use of other additives as a source of Cr(III) for nutritional purposes, namely a cellular bound chromium yeast (EFSA ANS Panel, 2012a) and Cr(III) lactate tri-hydrate (EFSA ANS Panel, 2012b). In both cases, the opinions did not focus specifically to the safety of Cr(III) and in line with the EFSA ANS Panel (2010b) opinion concluded that an intake of Cr(III) from these sources below 250 µg/day was not of concern. In 2012, the Agency for Toxic Substances and Disease Registry (ATSDR) published a toxicological profile for chromium in humans and animals. In the case of Cr(III) the studies on oral toxicity were considered inadequate for establishing the exposure concentrations that are likely to be without appreciable risk of adverse effects (noncarcinogenic) (minimal risk level, MRL). Little or no information was identified regarding acute or intermediate-duration oral exposure to Cr(III) compounds. Several animal studies showed no adverse effects associated with chronic oral exposure to Cr(III) compounds (chromium acetate, chromium nicotinate, chromium oxide, chromium picolinate) even at very high daily doses, therefore an MRL was not derived (ATSDR, 2012). Chromium VI The US National Institute for Occupational Safety and Health (NIOSH, 2002) considered all Cr(VI) compounds to be potential occupational carcinogens. Occupational exposure to Cr(VI) compounds is associated with lung, nasal, and sinus cancer. Other local effects include nasal irritation and ulceration, and perforation of the nasal septum and eardrum. Dermal exposure to Cr(VI) compounds can cause skin irritation, ulceration, sensitization, and allergic contact dermatitis. The WHO guideline value for chromium in water of 0.05 mg/litre appears to have been established in the first edition of the WHO drinking water guidelines in 1984/85, and the basis for its derivation is unclear. The second edition (WHO, 1993) and third edition of the guidelines (2003) both noted that different guideline values for CrIII and CrVI should be derived, but analytical methods favoured a guideline value for total Cr. They also noted that because of the carcinogenicity of CrVI by the inhalation route and its genotoxicity, the current guideline value of 0.05 mg/litre had been questioned, but the available toxicological data did not support the derivation of a new value. As a practical measure, 0.05 mg/litre, which was considered to be unlikely to give rise to significant risks to health, EFSA Journal 2014;12(3):3595 22
Chromium in food and drinking water was retained as the provisional guideline value until additional information became available and chromium could be re-evaluated. In 2012, ATSDR published a toxicological profile for chromium in humans and animals. In the case of Cr(VI) compounds an oral MRL of 0.005 mg/kg b.w. per day was derived for intermediate (15-364 days) exposure based on haematological effects (microcytic, hypochromic anemia) in rats (NTP, 2008). An oral MRL of 0.001 mg/kg b.w. per day was derived for chronic exposure (> 1 year) by selecting as the critical effect nonneoplastic lesions of the duodenum as reported in a chronic drinking water study (NTP, 2008< ATSDR, 2012). Chromium(VI) compounds have been evaluated by several IARC working groups in different years (1973, 1979, 1980, 1982, 1987, 1990 and 2012). IARC concluded that there was sufficient evidence in humans for the carcinogenicity of Cr(VI) compounds, with respect to the cancer of the lung and also cancer of the nose and nasal sinuses. There was sufficient evidence in experimental animals for the carcinogenicity of Cr(VI) compounds. Therefore, Cr(VI) compounds are carcinogenic to humans (Group 1) (IARC, 2012). U.S. EPA assessed chromium in 1998 (U.S. EPA, 1998a) and is currently reviewing the health effects of Cr(VI) and may set new limits in drinking water if needed in the future 7 . The International Programme on Chemical Safety (IPCS) published an assessment of the risk to human health and the environment of inorganic chromium(VI) compounds (WHO/IPCS, 2013). This evaluation is based principally on the Toxicological profile for chromium prepared by ATSDR in 2000 and on its update published in 2008. The IPCS derived an oral TDI for non-cancer effects of 0.9 µg chromium(VI)/kg b.w. per day taking into account the data relative to diffuse epithelial hyperplasia in the duodenum observed in female mice after exposure to sodium dichromate dihydrate in drinking-water. This TDI was based on a BMDL 10 of 0.094 mg/kg b.w. per day calculated by ATSDR (ATSDR, 2012) and the application of an uncertainty factor of 100. Concerning the neoplastic effects observed in the oral cavity in rats and small intestine in mice, IPCS noted that genotoxic mechanisms may be involved in the mode of action and there are no reasons for excluding a similar mode of action in humans. However, it was recognized that ther is a high degree of uncertainty on the relevance of these effects to humans because the processes and factors that determine absorption and metabolism in rodents and humans are not fully understood. Therefore, no hazard characterisation for neoplastic effects was performed. 1.4. Dietary reference values Chromium has been viewed as an essential element with a role in the maintenance of carbohydrate, fat, and protein metabolism. Safe and adequate dietary intakes have been established by some institutional bodies. In 1989, the US National Research Council (NRC), Food and Nutrition Board established an ‘estimated safe and adequate daily dietary intake’ range for chromium. For adults and adolescents that range was 50 to 200 g per day (NRC, 1989). The UK Committee on Medical Aspects of Food Policy (COMA) suggested that an adequate and safe level of intake lay above 25 g/day chromium for adults and between 0.1 and 1.0 g per day for children and adolescents (COMA, 1991). COMA also noted that no adverse effects were observed for intakes ranging between 1000 to 2000 g Cr(III) per day. The Institute of Medicine (IOM) of the National Research Council (NRC) determined the adequate intakes (AI) for chromium for different age groups (IOM, 2001). The AI ranged from 0.2-5.5 µg/day for infants to 35 µg/day for males between 19 and 50 years old. The suggested intakes were 29-30 µg/day during pregnancy and 44-45 µg/during lactation. However, it should be noted that on the basis of the currently available data it is questionable whether chromium is an essential element. In its opinion on nutrient and energy intakes, the Scientific 7 http://water.epa.gov/drink/contaminants/basicinformation/chromium.cfm EFSA Journal 2014;12(3):3595 23
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