The application for the ingredient monomethylsilanetriol (MMST) was filed by Irish company LLR-G5, which manufactures Organic Silicon G5.
The issue dates back to 2009, when EFSA said there was inadequate bioavailability and toxicity data to confirm the safety of the ingredient.
Then in 2013 the Food Safety Authority of Ireland (FSAI) said the ingredient needed further assessment before being added to the list of vitamins and minerals allowed in food supplements in the EU (Annex II of Regulation (EC) No 1170/2009).
Silicon is already allowed as a mineral in food supplements, but MMST is a novel food in that it is a “new or intentionally modified primary molecular structure”.
Silicon is typically present in food in the form of orthosilicic acid (OSA), which is readily absorbed from the gastrointestinal tract in humans and excreted in urine.
EFSA’s latest assessment looked at the bioavailability of OSA when “liberated” from MMST.
In this assessment requested by the European Commission, EFSA’s Food Additives and Nutrient Sources Added to Food (ANS) panel concluded MMST as a source of silicon at levels of 115 mg per litre was “not of safety concern”.
“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."
LLR-G5's head of marketing, Amanda Dolan, told us the company was proud of the opinion it "persevered and pioneered" to get.
"It's taken about 10 years of research to get this positive opinion from EFSA."
She said the opinion affirmed its faith in the ingredient and it would await the final approval from the European Commission before formulating its next steps, which would include market expansion and could include a health claim application. France is the main market for the company, which is based in Ireland but was founded by two French men in 1999.
19 rejected claims
There have been 19 health claim applications concerning silicon submitted by other companies and organisations, according to the EU’s register, however all have been rejected.
Claimed health benefits included bone health, skin elasticity, hair and nail formation, connective tissue formation and protection against aluminium accumulation in the brain.
LLR-G5's products claim to help support bone and joint health, connective tissue, skin vitality and the formation of cartilage.
Asked about the legality of these claims, Dolan said the company was working with regulatory consultants on its marketing, which could mean it removes these claims.
Its food supplement is a water-based product containing MMST, potassium and phosphate.
The company also sells topical gels and sprays.