No specific studies on bioavailability were made available on any of the manganese sources considered in this opinion. However it can be assumed that manganese sources will dissociate in the stomach and/or in the gastrointestinal fluids into their constituents and that bioavailability in the gastrointestinal tract would be at least similar to that from other dissociable sources of manganese. The Panel considers that exposure from these sources to aspartate, ascorbate, pidolate, and glycinate at the levels considered in this opinion would be of no safety concern. Using the highest proposed use level of 5 mg/day of manganese from the manganese sources considered in this opinion, the Panel noted that the total anticipated exposure to manganese from food intake and from food supplements would be 6.4-9.9 mg/day at the mean and 9.8-13.2 mg/day at the 97.5th percentile for adults. For children 3-14 years old, the total anticipated exposure to manganese from food intake and from food supplements would be 6.8-7.2 mg/day at the mean and 8.9-9.2 mg/day at the 97.5th percentile. The Panel considers that supplemental intake of 4 mg for the general population and 0.5 mg manganese/day for older people, respectively, are unlikely to produce adverse effects. This supplementation would result in total intakes of 12.2 for the general population and 8.7 mg manganese/day for older people, respectively, taking into consideration a level of dietary manganese intake of 8.2 mg/day. The Panel concludes that the use of manganese aspartate, manganese L-ascorbate, manganese pidolate and manganese bisglycinate, as sources of manganese in food supplements, are not of safety concern provided that the guidance levels for manganese supplementation set by the EVM are not exceeded, 4 mg manganese/day for the general population and 0.5 mg manganese/day for older people. The Panel concurs with the SCF considerations that exposure to manganese should remain low and should not exceed that found in the diet, taking into consideration that due to its ubiquity, the evidence for manganese deficiency in humans is limited, that manganese is an essential element found naturally in foods and that the margins of exposure between oral manganese levels showing neurotoxic effects and the estimated levels of manganese from the diet remain low.

Manganese ascorbate, manganese aspartate, manganese bisglycinate and manganese pidolate as sources of manganese added for nutritional purposes to food supplements

GRILLI, SANDRO;
2009

Abstract

No specific studies on bioavailability were made available on any of the manganese sources considered in this opinion. However it can be assumed that manganese sources will dissociate in the stomach and/or in the gastrointestinal fluids into their constituents and that bioavailability in the gastrointestinal tract would be at least similar to that from other dissociable sources of manganese. The Panel considers that exposure from these sources to aspartate, ascorbate, pidolate, and glycinate at the levels considered in this opinion would be of no safety concern. Using the highest proposed use level of 5 mg/day of manganese from the manganese sources considered in this opinion, the Panel noted that the total anticipated exposure to manganese from food intake and from food supplements would be 6.4-9.9 mg/day at the mean and 9.8-13.2 mg/day at the 97.5th percentile for adults. For children 3-14 years old, the total anticipated exposure to manganese from food intake and from food supplements would be 6.8-7.2 mg/day at the mean and 8.9-9.2 mg/day at the 97.5th percentile. The Panel considers that supplemental intake of 4 mg for the general population and 0.5 mg manganese/day for older people, respectively, are unlikely to produce adverse effects. This supplementation would result in total intakes of 12.2 for the general population and 8.7 mg manganese/day for older people, respectively, taking into consideration a level of dietary manganese intake of 8.2 mg/day. The Panel concludes that the use of manganese aspartate, manganese L-ascorbate, manganese pidolate and manganese bisglycinate, as sources of manganese in food supplements, are not of safety concern provided that the guidance levels for manganese supplementation set by the EVM are not exceeded, 4 mg manganese/day for the general population and 0.5 mg manganese/day for older people. The Panel concurs with the SCF considerations that exposure to manganese should remain low and should not exceed that found in the diet, taking into consideration that due to its ubiquity, the evidence for manganese deficiency in humans is limited, that manganese is an essential element found naturally in foods and that the margins of exposure between oral manganese levels showing neurotoxic effects and the estimated levels of manganese from the diet remain low.
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/11585/101814
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