For information, in order to have an intake of 250 µg of chromium from chromium(III) lactate, the anticipated daily intake of lactate would be 1.28 mg. The Panel concludes that because of the complex chemistry of lactate in aqueous solutions and limited solubility at pH >5, the bioavailability of from lactate is low and likely to be similar to other organic chromium-containing compounds. Information on the toxicity of lactate is very limited but there was some evidence of chromium compound-related effects in a rat study at the top dose group. The Panel concludes that this study is poorly presented, has not been peer-reviewed and is based on an insufficient number of animals per dose group. The Panel considers that the limited changes reported by Chromium(III) lactate trihydrate as a source of chromium added for nutritional purposes to food supplements the petitioner are not of toxicological significance. The Panel therefore concludes that the use of chromium(III) lactate, at the proposed use levels, is of no safety concern provided that the maximum level of chromium supplementation identified by the WHO is not exceeded. The Panel concludes that the exposure to lactate arising from the use of chromium(III) lactate in food supplements, at the proposed use levels, is of no safety concern. The Panel also notes that recent reviews and evaluations of chromium(III) point at conflicting outcomes of genotoxicity assays and report diverging views and conclusions on the consequences of this genotoxicity issue for the ultimate safety assessment of chromium(III). The Panel is aware that given this situation, the safety of chromium(III) might need to be reevaluated in light of the recent reviews and evaluations.

Chromium(III) lactate trihydrate as a source of chromium added for nutritional purposes to food supplements

GRILLI, SANDRO;
2009

Abstract

For information, in order to have an intake of 250 µg of chromium from chromium(III) lactate, the anticipated daily intake of lactate would be 1.28 mg. The Panel concludes that because of the complex chemistry of lactate in aqueous solutions and limited solubility at pH >5, the bioavailability of from lactate is low and likely to be similar to other organic chromium-containing compounds. Information on the toxicity of lactate is very limited but there was some evidence of chromium compound-related effects in a rat study at the top dose group. The Panel concludes that this study is poorly presented, has not been peer-reviewed and is based on an insufficient number of animals per dose group. The Panel considers that the limited changes reported by Chromium(III) lactate trihydrate as a source of chromium added for nutritional purposes to food supplements the petitioner are not of toxicological significance. The Panel therefore concludes that the use of chromium(III) lactate, at the proposed use levels, is of no safety concern provided that the maximum level of chromium supplementation identified by the WHO is not exceeded. The Panel concludes that the exposure to lactate arising from the use of chromium(III) lactate in food supplements, at the proposed use levels, is of no safety concern. The Panel also notes that recent reviews and evaluations of chromium(III) point at conflicting outcomes of genotoxicity assays and report diverging views and conclusions on the consequences of this genotoxicity issue for the ultimate safety assessment of chromium(III). The Panel is aware that given this situation, the safety of chromium(III) might need to be reevaluated in light of the recent reviews and evaluations.
F. Aguilar; U.R. Charrondiere; B. Dusemund; P. Galtier; J. Gilbert; D.M. Gott; S. Grilli; R. Guertler; G.E.N. Kass; J. Koenig; 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. Woutersen.
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11585/90132
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