Scientific Opinion on the safety of trivalent chromium as a nutrient added for nutritional purposes to foodstuffs for particular nutritional uses and foods intended for the general population (including food supplements)

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Article
Panel on Food Additives and Nutrient Sources Added to Food
Acknowledgements

The Panel wishes to thank the members of the Working Group B on Food Additives and Nutrient Sources added to Food: M. Bakker, D. Boskou, B. Dusemund, D. Gott, T. Hallas-Møller, A. Hearty, J. König, D. Marzin, D. Parent-Massin, I.M.C.M. Rietjens, G.J.A. Speijers, P. Tobback, T. Verguieva, R.A. Woutersen for the preparatory work on this scientific opinion.

EFSA Journal
EFSA Journal 2010;8(12):1882 [46 pp.].
doi
10.2903/j.efsa.2010.1882
Panel members at the time of adoption
F. Aguilar, B. Dusemund, P. Galtier, J. Gilbert, D.M. Gott, S. Grilli, R. Gürtler, J. König, C. Lambré, J-C. Larsen, J-C. Leblanc, A. Mortensen, D. Parent-Massin, I. Pratt, I.M.C.M. Rietjens, I. Stankovic, P. Tobback, T. Verguieva, R.A. Woutersen
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2009-00870
Adopted
10 November 2010
Published
1 December 2010
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

The Panel on Food Additives and Nutrient Sources added to Food delivers a scientific opinion re-evaluating the safety of chromium(III) as a nutrient added to foods for particular nutritional uses (PARNUTS) and foods intended for the general population (including food supplements). The Panel concluded that following oral administration, trivalent chromium is poorly absorbed. The results of in vitro bacterial mutagenicity assays have been consistently negative. The results of other genotoxicity studies are conflicting. The Panel also evaluated new in vitro and in vivo studies on the genotoxicity of chromium(III) compounds which were not covered by previous evaluations. The Panel concluded that in very large amounts, certain trivalent chromium compounds are cytotoxic and have been shown to cause chromosomal damage. The Panel also evaluated the data on long-term toxicity and carcinogenicity for chromium(III). Based on the facts i) that maximum intake levels of up to 250 µg/day for supplemental intake as suggested by the WHO would be in the same order of magnitude as the exposure resulting from normal dietary intake, ii) that in vitro, at high concentrations, chromium(III) might cause DNA damage, iii) that this DNA damage is not reflected in in vivo genotoxicity assays performed according to standard OECD protocols and in NTP studies, iv) that chromium(III) is not carcinogenic, v) that there is a large margin of safety of 4 to 5 orders of magnitude between a daily intake of 250 µg/day, equivalent to 4.1 µg/kg bw/day for a 60 kg person, and the NOAEL calculated for chromium(III) from the NOAEL for chromium(III) picolinate in the long-term NTP studies in mice and rats, , the Panel concluded that the safety of chromium(III) as a nutrient added to PARNUTS and foods intended for the general population (including food supplements) is not of concern, provided that the intake of chromium(III) from these sources does not exceed 250 µg/day, the value established by the WHO for supplemental intake of chromium that should not be exceeded.

Keywords
Trivalent chromium, nutrient, food supplements, foods for particular nutritional uses (PARNUTS)
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Number of Pages
46