Novel silicon gains EFSA approval for food supplement use
The application was made by Nuraveris on behalf of Eytelia labs (formerly Dexsil Labs), a manufacturer and distributor of food supplements and body gels based on organic silicium.
Here, the Belgium-based firm’s application describes the vanillin-stabilised form of orthosilicic acid intended for use as a source of silicon specifically for food supplements.
News of its successful outcome ends a process that began in February 2014, in which an initial assessment was carried out by Food Safety Authority Ireland (FSAI) in December 2014.
Additional information was required on two occasions (April and September 2017) in response to requests from EFSA.
OSA-VC: Panel thoughts
OSA-VC now join choline-stabilised orthosilicic acid (ChOSA), silicon dioxide, silicic acid in the form of gel and organic silicon (monomethylsilanetriol) as a silicon source authorised for use in the manufacture of food supplements.
In its OSA-VC form, the Panel concluded that there would be no safety concern with the proposed use and use level of OSA-VC, which Eytelia proposed at 15 millilitres per day (mL/day) of dietary supplement (containing 98.9% OSA-VC complex), equivalent to 14.8 mL OSA-VC.
The proposed use was limited to the adult population and not intended for children.
“The daily consumption of OSA-VC at the daily dose recommended by the applicant would provide a supplemental intake of silicon of approximately 10–18 mg/day which would result in an estimated total intake from supplement use and from the diet of roughly 30–70 mg silicon/day,” EFSA stated.
“This would not exceed the safe upper level of supplemental silicon intake of 700 mg/day of Si for adults as set by the UK Expert group on Vitamins and Minerals (EVM) in 2003.”
Additional recommendations by the panel also placed parameters for ethanol, phosphorus and phosphate ions - residual produce formed during the manufacturing process.
Organique G5 products
On its website Eytelia describe its design and manufacturing process that uses bio activated organic silicum in combination with ingredients such as monosodium glutamate, glucosamine, chondroitin as well as essential oils and plant extracts.
Eytelia’s success mirrors that of Irish company LLR-G5. In November 2016, the firm also received EFSA approval for its ingredient monomethylsilanetriol (MMST).
The ingredient is a novel food that according to EFSA is a “new or intentionally modified primary molecular structure”.
It is a key ingredient for the firms’ Silicum Organique G5 product range, said to provide a boost to bone density, skin, hair and nails as well as the prevention of cholesterol plaque formation in the arteries.
