Gnosis, the company behind the novel ingredient, has said that the ruling which took into account safety and bioavailability will open the way for commercialization in Europe and beyond in the coming months.
Gnosis CEO, Renzo Berna, said: “This opinion gives us great opportunities in the market place and a strong competitive position, not only in Europe, but also in other parts of the world that is influenced by regulatory decisions taken in the EU.”
The company said this was a key milestone within its global strategic plan which has already seen the approval of Quatrefolic as a New Dietary Ingredient (NDI) by the FDA back in 2010.
Marco Lattanzi, Gnosis’ area manager for Europe, told NutraIngredients that the company had already established Quatrafolic as a well-known product in countries all over the world like the US. “Now we can get into the European market which is completely new for us - for Quatrafolic of course,” Lattanzi explained.
After receiving this EFSA scientific thumbs up the company must now wait for approval of Quatrefolic as a final supplement product from the European Commission, he told us.
What the folic is Quatrefolic?
Quatrefolic is a folate derivative made up of methyltetrahydrofolate and glucosamine salt.
Methyltetrahydrofolic acid- calcium salt, has already been authorised as a source of folate, while this latest petition proposed methyltetrahydrofolic-glucosamine as an alternative source to be used in the manufacturing of food supplements at a does of up to 1.8 mg/day, which equates to 1mg methyltetrahydrofolic acid and 0.8mg glucosamine.
After performing a crossover comparative bioavailability study in human volunteers the EU authority concluded that folate from glucosamine salt exhibited a similar bioavailability to folate from calcium salt.
The results showed that the methyltetrahydrofolic-glucosamine will readily dissociate to individual compounds in the aqueous environment of the digestive tract and therefore the methyltetrahydrofolic component is expected to be absorbed across the small intestine in a similar manner as that originating from dietary sources and methyltetrahydrofolic-calcium.
The Panel concluded that the proposed use and levels of methyltetrahydrofolic-glucosamine is not of safety concern.
Lattanzi told NutraInredients that Quatrefolic is the only example of this folate combination globally and is protected by two international patents and is a registered trademark. The Gnosis Group includes a European manufacturing network in Italy, the US and China.