Abstract

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion on the safety and bioavailability of chromium(III) lactate tri-hydrate as a source of chromium(III) added for nutritional purposes to foodstuffs. The safety of chromium itself, in terms of the amounts that may be consumed, is outside the remit of this Panel. No new data have been provided as regards the safety and bioavailability of chromium from chromium(III) lactate tri-hydrate. The Panel concurs with its earlier views stating that no evidence was provided supporting the bioavailability of chromium from chromium(III) lactate tri-hydrate. Chromium(III) lactate tri-hydrate is claimed to be freely soluble in water, however, chromium(III) lactate tri-hydrate exists as a weak complex that may influence the bioavailability of chromium(III) in the gastrointestinal tract. The Panel re-iterates that because of the complex chemistry of chromium(III) lactate tri-hydrate in aqueous solutions and its limited solubility at pH >5, the bioavailability of chromium(III) from chromium(III) lactate tri-hydrate is low. Based on a conservative exposure estimate, the Panel calculated the combined intake of chromium(III) from supplements and from foods fortified with chromium(III) lactate tri-hydrate, for both adults and children, to be approximately 240 μg chromium(III)/day, which is below the value of 250 µg/day established by the WHO for supplemental intake of chromium that should not be exceeded. The Panel noted that the use of chromium(III) lactate tri-hydrate in the form of a premix with lactose, added to foods, would result in an exposure at the mean for adults of approximately 7–37 mg lactose/day (0.12-0.62 μg lactose/kg bw/day) and to 36–192 μg lactate/day (0.60-3.20 μg/kg bw/day). Given that subjects with lactose maldigestion will tolerate up to 12 g of lactose with no or minor symptoms, these levels are not of safety concern.

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