Scientific Opinion on the safety of chromium picolinate as a source of chromium added for nutritional purposes to foodstuff for particular nutritional uses and to foods intended for the general population

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Article
Panel on Food Additives and Nutrient Sources Added to Food
EFSA Journal
EFSA Journal 2010;8(12):1883 [49 pp.].
doi
10.2903/j.efsa.2010.1883
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
Acknowledgements

The Panel wishes to thank the members of the ANS Working Group B on Food Additives and Nutrient Sources: 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.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2009-00763
Adopted
10 November 2010
Published in the EFSA Journal
1 December 2010
Last Updated
13 December 2010. This version replaces the previous one/s.
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

Following a request from the European Commission, the Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion on the safety of chromium picolinate as a source of chromium added for nutritional purposes to foodstuff for particular nutritional uses (PARNUTS) and to foods intended for the general population, and on the bioavailability of chromium from this source. Chromium picolinate is obtained synthetically. The Panel noted that specifications for chromium(III) picolinate should ensure that levels of chromium(VI) which is a genotoxic carcinogen are as low as possible and at least are such that they result in an adequate margin of exposure. The Panel noted that results of the new genotoxicity studies suggest that in vitro at high concentrations chromium picolinate might cause DNA damage. From long-term carcinogenicity studies, it was concluded that there was equivocal evidence for the carcinogenic activity of chromium picolinate in male rats, and no evidence of carcinogenic activity of chromium picolinate in female rats, and female and male mice. The incidences of preputial gland adenomas were not dose related and did not occur consistently across species, and not across sexes. They are rather common in the rat strain used. Therefore the Panel concluded that a NOAEL could be established. The Panel noted that the margin of safety between the NOAEL of 2400 mg/kg bw/day chromium picolinate, resulting from the long-term study conducted by the NTP, equivalent to 2100 mg/kg bw picolinate/day would amount to at least four orders of magnitude assuming a combined intake of picolinate from all sources. The Panel concluded that the uses of chromium(III) picolinate as a source of chromium added for nutritional purposes to PARNUTS and foods intended for the general population (fortified foods and food supplements)would not be of concern provided that the amount of total chromium does not exceed 250 μg/day, the value established by the WHO for supplemental intake of chromium that should not be exceeded.

Keywords
Food supplements, chromium picolinate, CAS Registry Number 14639-25-9
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Number of Pages
49