Scientific Opinion on ChromoPrecise® cellular bound chromium yeast added for nutritional purposes as a source of chromium in food supplements and the bioavailability of chromium from this source

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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: Fernando Aguilar, Martine Bakker, Riccardo Crebelli, Birgit Dusemund, David Gott, Torben Hallas-Møller, Jürgen König, Daniel Marzin, Alicja Mortensen, Iona Pratt, Paul Tobback, Ine Waalkens-Berendsen, Rudulf Antonius Woutersen for the preparatory work on this scientific opinion.

EFSA Journal
EFSA Journal 2012;10(11):2951 [27 pp.].
doi
10.2903/j.efsa.2012.2951
Panel members at the time of adoption
Fernando Aguilar, Riccardo Crebelli, Birgit Dusemund, Pierre Galtier, David Gott, Ursula Gundert-Remy, Jürgen König, Claude Lambré, Jean-Charles Leblanc, Alicja Mortensen, Pasquale Mosesso, Dominique Parent-Massin, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Rudulf Antonius Woutersen, Matthew Wright
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2011-00930
Adopted
31 ottobre 2012
Published
23 novembre 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of ChromoPrecise® cellular bound chromium yeast added for nutritional purposes as a source of chromium in food supplements and the bioavailability of chromium from this source. ChromoPrecise® is a yeast preparation with an enriched trivalent chromium content, obtained by culture of Saccharomyces cerevisiae in the presence of chromium chloride. A daily intake of 100 µg chromium(III). There are limited data on the nature and identity of the organic chromium(III) compounds contained in chromium-enriched yeast and on their toxicokinetic and toxicodynamic behaviour in the body. Overall, the Panel concluded that the bioavailability in man of chromium from chromium-enriched yeast is potentially up to approximately ten times higher than that of chromium from chromium chloride. A NOAEL of 2500 mg/kg bw/day ChromoPrecise® was identified in a 90-day feeding study in rats; no evidence of adverse effects of chromium yeasts were reported in other animal studies investigating the effects of dietary supplementation with chromium yeast. ChromoPrecise® chromium yeast was non-genotoxic in a range of in vitro genotoxicity studies. Although no information was available on the chronic toxicity, carcinogenicity or reproductive toxicity of ChromoPrecise® chromium yeast, the ANS Panel has previously concluded that trivalent chromium is not carcinogenic, and limited data on other chromium yeasts provide no evidence of an effect on reproductive endpoints. No adverse effects have been reported in clinical efficacy trials with chromium yeasts. The Panel concluded that the use of ChromoPrecise® chromium yeast in food supplements is not of concern, despite the lack of data on the nature and identity of the organic chromium(III) compounds contained in the product, provided that the intake does not exceed 250 μg/day, as recommended by the WHO.

Keywords
ChromoPrecise® cellular bound chromium yeast, chromium(III), food supplements
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Number of Pages
27