REGULATORY STATUS

As GRAS assessment declaims, "Quatrefolic® has been rigorously tested for safety and consistency. It is produced under strict quality control procedures allowing Gnosis to promote the product for application in a variety of conventional foods, beverages and supplements."

This is one of the many achievements earned by Quatrefolic® during just few years of commercialization.

Here a summary of the best-gained recognitions of Quatrefolic®, the innovative folate:


August 2010 USA: GRAS (generally recognized as safe self-affirmation)
An independent expert panel confirms that Quatrefolic®, (6S)-5-methyltetrahydrofolic acid glucosamine salt, is "generally recognized as safe" ("GRAS") for use as a source of folate in conventional and medical foods.


December 2010 USA: FDA New Dietary Ingredient Notification
FDA accepts notification of Quatrefolic® as a source of the naturally-occurring form of folate for use in dietary supplements.


October 2013 EUROPE: EFSA Positive Scientific Opinion
EFSA states that Quatrefolic® can be added for nutritional purposes to food supplements as a source of folate.


March 2014 EUROPE: Novel Food approval
The European Commission approves the use of Quatrefolic® in the European Union as a Novel Food Ingredient to be used in food supplements.


March 2015 EUROPE: Joining Annex II to Directive 2002/46/EC
Following the Authority's favorable opinion, the list set out in Annex II to Directive 2002/46/EC of vitamin and mineral substances is officially amended to include Quatrefolic®, the glucosamine salt of (6S)-5-methyltetrahydrofolic acid: it may be used in the manufacture of food supplements of European Community.


August 2016 AUSTRALIA: TGA approval
Quatrefolic® has been positively evaluated for safety and approved as permitted ingredient for listed medicines by the Therapeutic Goods Administration (TGA), a part of the Australian Government Department of Health.


June 2017 SOUTH KOREA: FDA official addiction to the Food Additive Code
The Ministry of Food and Drug Safety (MFDS) approves Quatrefolic® as Food Additive in South Korea with the permitted claims of necessary for maintenance of normal blood homocysteine levels, necessary for proper growth of a fetal neural tube and for the production of cells and blood.


October 2017 CHINA: National Health and Family Planning Commission of the PRC authorization
The National Health and Family Planning Commission of the officially notifies that Quatrefolic® is publicly authorized as Food Nutritional Fortification Substance with a specific monograph that describes its quality (physical, chemical and microbiological) requirements.


Further regulatory approvals are in progress in several countries around the world. For more information regarding the regulatory status of Quatrefolic®, please contact us.


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