Scientific Opinion in relation to the use of monomethylsilanetriol to be added for nutritional purposes to food supplements in the light of new data provided
F. Aguilar, B. Dusemund, P. Galtier, J. Gilbert, D.M. Gott, S. Grilli, R. Gürtler, J. König, 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
Acknowledgment
EFSA wishes to thank the members of the ANS Working Group B on Food Additives and Nutrient Sources for the preparation of this opinion: M. Bakker, D. Boskou, B. Dusemund, D. Gott, T. Hallas-Møller, A. Hearty, J. König, D. Marzin, D. Parent-Massin, I.M.C.M. Rietjens, G.J.A. Speijers, P. Tobback, T. Verguieva, R.A. Woutersen.
Contact
ans@efsa.europa.eu
The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion on the use ofmonomethylsilanetriol added for nutritional purposes to food supplements. The Panel was asked to evaluate towhich extent newly submitted information addresses the uncertainties expressed in its opinion on“Monomethylsilanetriol added for nutritional purposes to food supplements” in 2009. The Panel noted that thenewly submitted information relates to the bioavailability of silicon from, and to the toxicology of a sourcesubstance designated as monomethylsilanetriol orthohydroxybenzoate sodium salt (MSS). This substance differsfrom the substances evaluated by the Panel in 2009 since, unlike the substances evaluated previously, thecommercial form of MSS consists of an aqueous solution of salicylic acid (orthohydroxybenzoic acid),monomethylsilanetriol and sodium chloride. In the light of the newly submitted information and given the factthat the presence of salicylic acid in MSS may influence the bioavailability of silicon from MSS, and the toxicityof MSS, the Panel concluded that the new data are insufficient to fill the data gaps on the bioavailability ofsilicon from monomethylsilanetriol and on the toxicity of monomethylsilanetriol, which were highlighted in theopinion of 2009. The Panel therefore concludes, that the newly submitted information does not adequatelyaddress the uncertainties expressed in the previous opinion and would not justify the re-evaluation ofmonomethylsilanetriol added for nutritional purposes in food supplements.
© European Food Safety Authority, 2010
Following a request from the European Commission to the European Food Safety Authority (EFSA), the Panel on Food Additives and Nutrient Sources added to Food (ANS) has been asked to evaluate the extent to which newly submitted information addresses the uncertainties expressed in the opinion on Monomethylsilanetriol added for nutritional purposes to food supplements expressed in 2009 by the ANS Panel and would justify the re-evaluation of monomethylsilanetriol.
The 2009 opinion was based on the request and dossiers provided by two petitioners who applied for the use of monomethylsilanetriol to be added for nutritional purposes to food supplements, either as such or as its potassium salt. Based on the information provided, the Panel concluded that “Given the absence of adequate data on the bioavailability of silicon from monomethylsilanetriol and the toxicity of monomethylsilanetriol, the Panel could not assess the safety of the source and the bioavailability of silicon from this source.”
The Panel noted that the newly submitted information relates to the bioavailability and the toxicology of a substance (MSS) that differs from the substances evaluated by the ANS Panel in 2009. In MSS the monomethylsilanetriol molecule is linked to a sodium salicylate (orthohydroxybenzoate) molecule by hydrogen bonding. The association of monomethylsilanetriol with sodium salicylate prevents polycondensation of monomethylsilanetriol and gives rise to a condensation structure which keeps monomethylsilanetriol in solution.
Given that the presence of salicylic acid in MSS may influence the bioavailability of silicon from MSS and the toxicity of MSS, the Panel noted that the newly submitted data are insufficient to fill the data gaps on the bioavailability of silicon from monomethylsilanetriol and the toxicity of monomethylsilanetriol, which were highlighted in the opinion expressed by the ANS Panel in 2009.
The Panel concludes that the newly submitted information does not adequately address the uncertainties expressed in the opinion of the ANS Panel and would not justify the re-evaluation of monomethylsilanetriol added for nutritional purposes to food supplements.
Monomethylsilanetriol, CAS No. 2445-53-6, silanetriol, methyl siliconate, methylsilanetriolate, methylsilanetriol, organic silicon, food supplements
