EU clears Quatrefolic for use in food supplements

EU clears Quatrefolic for use in food supplements

List of vitamin and mineral substances set out in Annex II to Directive 2002/46/EC has been officially amended to include the glucosamine salt of (6S)-5-methyltetrahydrofolic acid.

Following the Authority's favorable opinion the list of vitamin and mineral substances, set out in Annex II to Directive 2002/46/EC, has been officially amended to include Quatrefolic®, the glucosamine salt of (6S)-5-methyltetrahydrofolic acid which may be used in the manufacture of food supplements sold inside of European Community.

This is the consequence of the positive Scientific Opinion adopted by the Authority on September 11th 2013 a Scientific Opinion about (6S)-5-methyltetrahydrofolic acid, glucosamine salt as a source of folate added for nutritional purposes to food supplements and the bioavailability of folate from this source.

(6S)-5-methyltetrahydrofolic acid, glucosamine salt is a novel food ingredient, the placing on the market of which has been authorized by Commission Implementing Decision 2014/154/EU, released on March 19, 2014.

Gnosis is investing many resources to document the benefits of Quatrefolic as a food ingredient for a healthier lifestyle and prove the superiority of reduced folate compared to folic acid.

Quatrefolic, as it provides the metabolic reduced folate form utilized and stored in the human body, the (6S)-5-methyltetrahydrofolate, may benefit certain genetic defects that influence folate metabolism.

Quatrefolic answers to all consumers’ and physicians’ concerns relating to potential harmful effects of folic acid administration. Quatrefolic supplementation does not aid to the potential accumulation of UMFA (unmetabolized folic acid) in the blood, which has no biological function and whose effects are not yet known, also due to the potential uncontrolled assumption of folic acid by diet.


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