Safety of organic silicon (monomethylsilanetriol, MMST) as a novel food ingredient for use as a source of silicon in food supplements and bioavailability of orthosilicic acid from the source

Abstract

Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient Sources added to food (ANS) was asked to deliver an opinion on the safety of organic silicon (monomethylsilanetriol, MMST) as a novel food ingredient for use as a source of silicon in food supplements, and on the bioavailability of silicon from this source. MMST is proposed to be used as an aqueous solution at a concentration of 4.1 mM, corresponding to 115 mg Si/L. The anticipated intake of silicon from the proposed uses and use levels of 60-90 mL/day of MMST solution corresponds to approximately 7-10 mg Si/day. Data from in vitro and in vivo tests showed no genotoxic effect of MMST. From a 90-day toxicity study in rats a no observed adverse effect level (NOAEL) was set at the concentration of 20.5 mM of MMST, corresponding to 232 mg/kg body weight (bw) per day of MMST, the highest dose tested and technically achievable. The Panel considered these data as fulfilling the requirements for the evaluation of the safety of the novel food ingredient and did not request additional testing neither for chronic toxicity and carcinogenicity nor for reprotoxicity and developmental toxicity. The Panel therefore concluded that the proposed use and use levels of MMST as a source of silicon to be used in food supplements is not of safety concern. The conversion of MMST to orthosilicic acid (OSA), the form under which silicon is typically present in food, could not be directly measured, and therefore, the Panel based its opinion on the indirect evidence provided and concluded that OSA is released from MMST and silicon bioavailable from the source. The Panel did not conclude on the safety of MMST in terms of the amount of silicon that may be consumed, as this is outside the remit of the ANS Panel. © European Food Safety Authority, 2016Keywords: organic silicon, monomethylsilanetriol, MMST, nutrient source, novel food ingredient, food supplements

Safety of orthosilicic acid‐vanillin complex (OSA‐VC) as a novel food ingredient to be used in food supplements as a source of silicon and bioavailability of silicon from the source

“…However, data from the scientific literature have established that silicon is typically present in food in the form of OSA which is absorbed from the gastrointestinal tract in humans, and then, silicon is readily excreted in urine. Therefore, in order to address the Terms of Reference of the current mandate and ensure consistency with previous scientific opinions issued on other sources of silicon (EFSA 2009a,b;EFSA ANS Panel, 2016), the Panel considered that bioavailability of OSA from OSA-VC should be the basis for the evaluation of the bioavailability of silicon from that source.…”

“…The Panel is aware that the mineral silicon (Si) is included in the positive lists of minerals that can be added to foods, including food supplements, as defined by Annex I to Regulation (EC) No 1925No /2006 address the Terms of Reference of the current mandate and ensure consistency with previous scientific opinions issued on other sources of silicon (EFSA 2009a,b;EFSA ANS Panel, 2016), the Panel considered that bioavailability of OSA from OSA-VC should be the basis for the evaluation of the bioavailability of silicon from that source.…”

Sources, Bioavailability, and Safety of Silicon Derived from Foods and Other Sources Added for Nutritional Purposes in Food Supplements and Functional Foods

“…During the manufacture of functional foods and dietary supplements, the polymerization of silicic acid to polysilicic acid is often prevented to aid bioavailability. To prevent polymerization, several methods of stabilization have been developed, for example, introducing a methyl group to obtain monomethylsilanetriol (MMST) or "organic silicon" [39,40], stabilization with choline to form choline-stabilized orthosilicic acid (ch-OSA) [39,41], or combining with vanillin to form orthosilicic acid vanillin complex (OSA-VC) [41,42]. In addition, amorphous diatomaceous earth is of great interest both as a source of organic silicon and as an additive with multidirectional health-promoting effects [1].…”

“…Beverages such as water and beer predominantly contain soluble monomeric species that are readily absorbed [33]. At higher silicon concentrations (above 2-3 mM, in most supplements), less absorbable and larger colloids or polymers are present, with the exception of methylsilanetriol (MMST), in which one hydroxyl group of OSA is replaced by one methyl group, raising the solubility limit and maintaining the silicon in well-absorbed forms [40]. Ch-OSA (choline stabilized orthosilicic acid) contains polymerized silicon in a highly concentrated solution; however, extensive aggregation and polymerization of Si particles are prevented by the presence of choline in the solution [43].…”

“…Table 3. Opinion on the safety and bioavailability of silicon of mineral origin approved for use in the production of food supplements and as a food additive [39][40][41]47,48]. OSA-VC is produced by completely dissolving vanillin powder in 40% ethanol solution at 40 • C. The solution is then diluted with water and acidified to a pH of 1.5-2.5 using phosphoric acid.…”