REGULATORY STATUS

A GRAS ("Generally Recognized As Safe") assessment of the indepth safety and toxicity information was performed by an Independent Expert Panel. The Panel concluded that Quatrefolic® is GRAS for the proposed uses of a food ingredient as required by the Food & Drug Administration.

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.

After a deep review of the extensive safety information and the uniqueness of the Quatrefolic® compound, FDA has accepted the New Dietary Ingredient (NDI) notification for the ingredient concluding that a dietary supplement containing the new dietary ingredient is expected to be safe under the conditions of use recommended or suggested on the label.

The term "new dietary ingredient" means a dietary ingredient that was not marketed in the United States in a dietary supplement before October 15, 1994.

The NDI notification is a complex procedure. More than 80% of NDI notifications are rejected by the FDA due to insufficient evidence for safety, the absence of required elements, as well as incomplete document submitted.

The European Food Safety Authority (EFSA) has adopted a positive scientific opinion after a thorough assessment of the safety data and bioavailability studies, a process that has lasted for nearly two years and a half, concluding that Quatrefolic® may be added for nutritional purposes to food supplements as a source of folate.

The positive scientific opinion has been forwarded to the European Commission for releasing Novel Food authorization and subsequent amending of Food Supplements Directive 2002/46/EC.


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 supplement.


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 approved 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 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.


February 2016 CHINA: Quatrefolic® approved by Chinese Ministry of Health
Quatrefolic® has been approved as food additive by the Ministry of Health of the People's Republic of China (MOH) and it has been listed in the regulation GB 2760-2011-NATIONAL STANDARD OF FOOD SECURITY: Usage Standard of Food Additives, in the category related to Instant Drinks preparation.



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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