Panel members at the time of adoption
The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety ofChromoPrecise® 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.