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EU Novel foods approval

Quatrefolic primed for EU commercialisation

By Nicola Cottam , 02-Apr-2014
Last updated on 03-Apr-2014 at 10:20 GMT

Quatrefolic primed for EU commercialisation

The European Commission has finally given its approval to Quatrefolic as a food supplement within the EU following a positive ruling from the European Food Safety Authority (EFSA) last October.

Nutraceutical manufacturer, Gnosis Group, waited two and half years for the seal of approval from EFSA following a series of safety assessments and bioavailability studies. The approval paves the way for the commercialisation of Quatrefolic as a Novel Food Ingredient across the EU over the coming months.

Gnosis commercial director Paolo Malesani said: “Quatrefolic is a fourth generation product in a revolutionary format. It has longer-lasting stability, improved bioavailability, high water solubility and a well established safety record in the US.”

The folate ingredient consists of an active form of folate (6S)-5-methyltetrahydrofolate, or vitamin B9, combined with glucosamine salt. Methyltetrahydrofolic acid calcium salt was already approved as a source of folate in the EU but the new formulation will offer an alternative in food supplements at doses of up to 1.8 mg/day.

Folate versus folic acid

Unlike folic acid, which is synthetically produced, folate is the naturally occurring form of the vitamin and as such is easily absorbed. The vitamin cannot be synthesised by the body but is essential for cell formation: primarily to produce and repair DNA and is particularly crucial for rapid cell development and growth in foetus’.

Folate can be found in a wide range of vegetables but are susceptible to oxidation and much of the goodness is lost during processing and storage. Fresh leafy vegetables stored at room temperature may lose up to 70% of their folate activity within three days and up to 95% can be lost when cooked in boiling water.

A certain amount of folate can be stored in the body once ingested but deficiencies can lead to nerve damage, colon cancer, mental confusion and depression, heart palpitations, and complications in pregnancy.

Malesani explained: “Folate deficiency is one of the most common vitamin deficiencies around the world and supplementation offers a realistic solution. In addition, Quatrefolic provides an alternative to folic acid supplements which are harder to convert in the body and also mask the effects of vitamin B12 deficiency.”

The EU launch of Quatrefoilc is the next step in Gnosis’ global roll-out strategy that began in 2010 with the approval of Quatrefolic as a New Dietary Ingredient (NDI) and alternative to folic acid by the FDA in the US.

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