Iron (II) taurate and magnesium taurate. In 2009 the ANS Panel of EFSA expressed an opinion on taurine and D-glucurono-γ-lactone in “energy” drinks. The ANS Panel evaluated a new 13-week oral toxicity and neurotoxicity study in male and female rats, which included functional observational battery and locomotor activity tests. The new study confirmed the NOAEL of 1000 mg/kg bw/day (the highest dose level tested) established in the earlier 13-week study already described by the SCF in 2003, and provided evidence for a NOAEL of 1500 mg/kg bw/day for behavioural effects. This NOAEL of at least 1000 mg/kg bw/day is 23-fold higher than the estimated combined exposure to taurate from use levels proposed by the petitioner for iron (II) taurate and magnesium taurate. Given the facts that the NOAEL was the highest dose tested and that taurate is a natural body constituent, the Panel concludes that this margin of safety is sufficient. The Panel recognises that the major exposure to taurate (2554 mg) would come from the use of magnesium taurate as a source of magnesium as compared to an exposure of only 62 mg taurate resulting from the proposed use levels for iron (II) taurate. The margin of safety for the daily exposure to 62 mg taurate (amounting to 1 mg/kg bw/day for a 60 kg person) resulting from the proposed use levels of iron (II) taurate would be almost 1000 and based on this margin of safety the Panel concludes that the use of iron (II) taurate as a source of iron is not of safety concern. The margin of safety for the intake of 2554 mg taurate (amounting to 42.6 mg/kg bw/day for a 60 kg person) resulting from the proposed use of magnesium taurate up to dose levels of 250 mg magnesium a day would be 23. Given the facts that the NOAEL was the highest dose tested and that taurate is a natural body constituent, the Panel concludes that this margin of safety is sufficient and that the use of magnesium taurate as a source of magnesium at the proposed use levels is not of safety concern. The Panel notes that in addition to the diet and the supplement sources evaluated in this Opinion “energy” drinks can also be an important source of taurine (taurate). Combined intake of taurine from magnesium taurate and iron taurate from supplements at the proposed use levels, from “energy” drinks at the mean intake of 8.3 mg/kg bw/day and from the diet at 0.7 to 6.7 mg/kg bw/day would result in an exposure of 52.6 to 58.9 mg taurate/kg bw/day for a 60 kg person, resulting in a margin of safety of 17 to 19. Given the facts that the NOAEL was the highest dose level tested and that taurine is a natural body constituent, the Panel concludes that this margin of safety is sufficient. Magnesium acetyl taurate. The Panel notes that the proposed use levels of magnesium acetyl taurate result in exposure to magnesium at a level below the SCF’s UL of 250 mg magnesium per day for supplement use. Iron (II) taurate, magnesium taurate and magnesium acetyl taurate. The Panel notes that the toxicological database on acetyl taurine is limited. A 3-month oral toxicity study in rats revealed a NOAEL of 2250 mg/kg bw/day. Comparison of this NOAEL to the intake of acetyl taurate that would result from the proposed use levels of magnesium acetyl taurate of 3.9 to 11.7 mg acetyl taurate/kg bw/day results in a margin of safety of 192 to 577. Given the facts that the compound is an acetylated form of taurine and may thus represent a normal endogenous metabolite of taurine and that the compound does not contain a structural alert for genotoxicity the Panel considers this margin of safety adequate and concludes that the use of magnesium acetyl taurate as a source for magnesium at the proposed levels of use is not of safety concern.

Iron (II) taurate, magnesium taurate and magnesium acetyl taurate as sources of iron or magnesium added for nutritional purposes in food supplements

GRILLI, SANDRO;
2009

Abstract

Iron (II) taurate and magnesium taurate. In 2009 the ANS Panel of EFSA expressed an opinion on taurine and D-glucurono-γ-lactone in “energy” drinks. The ANS Panel evaluated a new 13-week oral toxicity and neurotoxicity study in male and female rats, which included functional observational battery and locomotor activity tests. The new study confirmed the NOAEL of 1000 mg/kg bw/day (the highest dose level tested) established in the earlier 13-week study already described by the SCF in 2003, and provided evidence for a NOAEL of 1500 mg/kg bw/day for behavioural effects. This NOAEL of at least 1000 mg/kg bw/day is 23-fold higher than the estimated combined exposure to taurate from use levels proposed by the petitioner for iron (II) taurate and magnesium taurate. Given the facts that the NOAEL was the highest dose tested and that taurate is a natural body constituent, the Panel concludes that this margin of safety is sufficient. The Panel recognises that the major exposure to taurate (2554 mg) would come from the use of magnesium taurate as a source of magnesium as compared to an exposure of only 62 mg taurate resulting from the proposed use levels for iron (II) taurate. The margin of safety for the daily exposure to 62 mg taurate (amounting to 1 mg/kg bw/day for a 60 kg person) resulting from the proposed use levels of iron (II) taurate would be almost 1000 and based on this margin of safety the Panel concludes that the use of iron (II) taurate as a source of iron is not of safety concern. The margin of safety for the intake of 2554 mg taurate (amounting to 42.6 mg/kg bw/day for a 60 kg person) resulting from the proposed use of magnesium taurate up to dose levels of 250 mg magnesium a day would be 23. Given the facts that the NOAEL was the highest dose tested and that taurate is a natural body constituent, the Panel concludes that this margin of safety is sufficient and that the use of magnesium taurate as a source of magnesium at the proposed use levels is not of safety concern. The Panel notes that in addition to the diet and the supplement sources evaluated in this Opinion “energy” drinks can also be an important source of taurine (taurate). Combined intake of taurine from magnesium taurate and iron taurate from supplements at the proposed use levels, from “energy” drinks at the mean intake of 8.3 mg/kg bw/day and from the diet at 0.7 to 6.7 mg/kg bw/day would result in an exposure of 52.6 to 58.9 mg taurate/kg bw/day for a 60 kg person, resulting in a margin of safety of 17 to 19. Given the facts that the NOAEL was the highest dose level tested and that taurine is a natural body constituent, the Panel concludes that this margin of safety is sufficient. Magnesium acetyl taurate. The Panel notes that the proposed use levels of magnesium acetyl taurate result in exposure to magnesium at a level below the SCF’s UL of 250 mg magnesium per day for supplement use. Iron (II) taurate, magnesium taurate and magnesium acetyl taurate. The Panel notes that the toxicological database on acetyl taurine is limited. A 3-month oral toxicity study in rats revealed a NOAEL of 2250 mg/kg bw/day. Comparison of this NOAEL to the intake of acetyl taurate that would result from the proposed use levels of magnesium acetyl taurate of 3.9 to 11.7 mg acetyl taurate/kg bw/day results in a margin of safety of 192 to 577. Given the facts that the compound is an acetylated form of taurine and may thus represent a normal endogenous metabolite of taurine and that the compound does not contain a structural alert for genotoxicity the Panel considers this margin of safety adequate and concludes that the use of magnesium acetyl taurate as a source for magnesium at the proposed levels of use is not of safety concern.
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.A. Woutersen.
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11585/90125
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