GRAS (generally recognised as safe self-affirmation)
August 2010:
An independent expert panel confirms that Quatrefolic®, (6S)-5-methyltetrahydrofolic acid glucosamine salt, is « generally recognised as safe » (« GRAS ») for use as a source of folate in conventional and medical foods.
FDA New Dietary Ingredient Notification
December 2010: FDA accepts notification of Quatrefolic® as a source of the naturally occurring form of folate for use in dietary supplements.
EFSA Positive Scientific Opinion
October 2013:
EFSA states that Quatrefolic® can be added for nutritional purposes to food supplements as a source of folate.
Novel Food approval
March 2014:
The European Commission approves the use of Quatrefolic® in the European Union as a Novel Food Ingredient to be used in food supplements.
Joining Annexe II to Directive 2002/46/EC
March 2015:
Following the authority’s favourable opinion, the list set out in Annexe 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 the European Community.
TGA approval
August 2016:
Quatrefolic® has been positively evaluated for safety and approved as a permitted ingredient for listed medicines by the Therapeutic Goods Administration (TGA), a part of the Australian Government Department of Health, Disability and Ageing.
Korea MFDS official adoption of the Food Additive Code
June 2017:
The Ministry of Food and Drug Safety (MFDS) approves (6S)-5-methyltetrahydrofolic acid glucosamine salt, Quatrefolic® as a Food Additive in South Korea.
National Health and Family Planning Commission of the PRC authorisation
October 2017:
China National Health and Family Planning Commission (NHFPC) officially approved (6S)-5-methyltetrahydrofolic acid glucosamine salt , Quatrefolic® as a nutrition fortification substance with a specific monograph that describes its quality (physical, chemical and microbiological) requirements.
China Taiwan approved as food ingredient
March 2018:
The safety of (6S)-5-methyltetrahydrofolic acid glucosamine salt , Quatrefolic® as food ingredient was evaluated by China Taiwan Ministry of Health and Welfare. Quatrefolic® has been approved as food ingredient following the same application scope established for folic acid.
India FSSAI approved as food additive
February 2019:
The Food Safety and Standards Authority of India (FSSAI) approved (6S)-5-methyltetrahydrofolic acid glucosamine salt, Quatrefolic® as new food additive.
Quatrefolic® is approved as a source of folic acid with the intended health benefits as per Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016.
Korea MFDS approved as health functional food ingredient
October 2019:
The Ministry of Food and Drug Safety (MFDS) in South Korea has approved Quatrefolic® as a health functional food ingredient, adding it to the Health Functional Food Code with permitted health claims below:
- Necessary for maintenance of normal blood homocysteine levels
- Necessary for proper growth of a fetal neural tube
- Necessary for the production of cells and blood.
Established Structure-Function Claims
May 2024:
The Dietary Supplement Health and Education Act of 1994 authorized producers of dietary supplements to use label statements describing the effect of a product on the structure and function of the body, and these “structure/function” statements are widely used.Quatrefolic® has successfully obtained an approved established list of structure-function claims for a wide range of applications. These claims are firmly grounded in the available scientific literature, with a reasonable basis supported by the extensive clinical studies on the subject.This achievement underlines Gnosis’s ongoing commitment to providing scientifically validated products and accurate, evidence-based information to consumers, and Quatrefolic® reinforces its position as a reliable source of active folate supplements.
CN NHC approves the use of (6S)-5-methyltetrahydrofolate glucosamine salt in nutrient supplementary food for pregnant and lactating women
December 2024:
(6S)-5-methyltetrahydrofolate glucosamine salt , Quatrefolic® has been approved for use in nutrient supplementary food for pregnant and lactating women by National Health Commission (NHC). This. approval signifies a significant milestone, as Quatrefolic® can now be formulated into products that support maternal health, adhering to GB 31601 standards.
China NHC published national food safety standard
March 2025:
The National Health Commission (NHC) has published a new national food safety standard for 6S)-5-methyltetrahydrofolic acid glucosamine salt, Quatrefolic®. This standard will serve as a mandated requirement for ensuring the quality and safety of this product in the Chinese market.
