No genotoxicity data are available on inositol hexanicotinate. However, as inositol hexanicotinate is hydrolysed to inositol and nicotinic acid, which are endogenous compounds and occur in several dietary products as well, the Panel concluded that the absence of genotoxicity data does not raise any concern. The petitioners indicate that inositol hexanicotinate acts as a slow-release supply of nicotinic acid and that therefore, the flushing effect is not likely to occur when inositol hexanicotinate is used as a source of niacin since the nicotinic acid molecules slowly hydrolyse from the inositol. The Panel notes that given the slow release of nicotinic acid from inositol hexanicotinate, the flushing effect, on the basis of which both the SCF and EVM have given Tolerable Upper Intake Levels for nicotinic acid, may be conservative for inositol hexanicotinate. However, given the absence of studies adequately supporting the absence of a flushing effect when dosing inositol hexanicotinate, the Panel concludes that the upper limit for nicotinic acid of 10 mg/day should also be used to judge the safety of inositol hexanicotinate. A daily dose of 10 mg nicotinic acid given as inositol hexanicotinate would amount to a daily dose of 11 mg inositol hexanicotinate, resulting in release of 2.4 mg inositol upon hydrolysis. Given the estimated normal dietary intake of inositol that amounts to 335-1500 mg myo-inositol (the most important form of naturally occurring inositol)/day, the Panel concludes that the intake of 2.4 mg inositol/day, resulting from intake of inositol hexanicotinate at a level that corresponds to a daily dose of 10 mg nicotinic acid, would not be of safety concern. The Panel concludes that the use of inositol hexanicotinate as a source for niacin, when added for nutritional purposes in food supplements intended for the general population, would be of no safety concern provided that use levels are in compliance with the defined upper safe use level for nicotinic acid (10 mg/day). However, the Panel is concerned that the use levels of inositol hexanicotinate proposed by the petitioners are 40 and 495 mg/day providing 36.4 and 450 mg nicotinic acid/day. These proposed use levels provide levels of nicotinic acid that are 4 to 45 times higher than the Tolerable Upper Intake Level of 10 mg nicotinic acid/day defined by the SCF in 2002.
Inositol hexanicotinate (inositol hexaniacinate) as a source of niacin (vitamin B3) added for nutritional purposes in food supplements / 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.. - In: EFSA JOURNAL. - ISSN 1831-4732. - ELETTRONICO. - 949:(2008), pp. 1-20.
Inositol hexanicotinate (inositol hexaniacinate) as a source of niacin (vitamin B3) added for nutritional purposes in food supplements
GRILLI, SANDRO;
2008
Abstract
No genotoxicity data are available on inositol hexanicotinate. However, as inositol hexanicotinate is hydrolysed to inositol and nicotinic acid, which are endogenous compounds and occur in several dietary products as well, the Panel concluded that the absence of genotoxicity data does not raise any concern. The petitioners indicate that inositol hexanicotinate acts as a slow-release supply of nicotinic acid and that therefore, the flushing effect is not likely to occur when inositol hexanicotinate is used as a source of niacin since the nicotinic acid molecules slowly hydrolyse from the inositol. The Panel notes that given the slow release of nicotinic acid from inositol hexanicotinate, the flushing effect, on the basis of which both the SCF and EVM have given Tolerable Upper Intake Levels for nicotinic acid, may be conservative for inositol hexanicotinate. However, given the absence of studies adequately supporting the absence of a flushing effect when dosing inositol hexanicotinate, the Panel concludes that the upper limit for nicotinic acid of 10 mg/day should also be used to judge the safety of inositol hexanicotinate. A daily dose of 10 mg nicotinic acid given as inositol hexanicotinate would amount to a daily dose of 11 mg inositol hexanicotinate, resulting in release of 2.4 mg inositol upon hydrolysis. Given the estimated normal dietary intake of inositol that amounts to 335-1500 mg myo-inositol (the most important form of naturally occurring inositol)/day, the Panel concludes that the intake of 2.4 mg inositol/day, resulting from intake of inositol hexanicotinate at a level that corresponds to a daily dose of 10 mg nicotinic acid, would not be of safety concern. The Panel concludes that the use of inositol hexanicotinate as a source for niacin, when added for nutritional purposes in food supplements intended for the general population, would be of no safety concern provided that use levels are in compliance with the defined upper safe use level for nicotinic acid (10 mg/day). However, the Panel is concerned that the use levels of inositol hexanicotinate proposed by the petitioners are 40 and 495 mg/day providing 36.4 and 450 mg nicotinic acid/day. These proposed use levels provide levels of nicotinic acid that are 4 to 45 times higher than the Tolerable Upper Intake Level of 10 mg nicotinic acid/day defined by the SCF in 2002.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
