Quatrefolic® receives Novel Food approval

DESIO, Italy – March, 31st 2014

Gnosis is pleased to announce that on March 19th, 2014 the European Commission approved the use of Quatrefolic® in the European Union as a Novel Food Ingredient to be used in food supplements. This opens the way for the commercialization of Quatrefolic in the 28 EU-member state market to Quatrefolic®.
The decision follows EFSA positive scientific opinion delivered in October 2013, which concluded that Quatrefolic is a safe and effective source of folate.

This key milestone is part of the global strategic plan that started in 2010 with the approval of Quatrefolic® as New Dietary Ingredient (NDI) by FDA. In the USA Quatrefolic® has become a benchmark for innovation, safety and quality in the folate supplementation.

About Quatrefolic®

Quatrefolic® is a source of the active form of folate (6S)-5-methyltetrahydrofolate, the essential form utilized in the methylation cycle and stored in the human body.

Quatrefolic® and Methionine are the key components of a vital biochemical process called the methylation cycle, also often referred to as one-carbon metabolism, which is required for normal cell function. There is evidence associating the negative effects of alterations and changes in the intermediates of the methylation cycle and reduced levels of folate and vitamin B12, with vascular disease, colon cancer, end-stage renal disease, diabetic neuropathy, and CNS disorders such as depression and cognitive impairment. Therefore maintaining the balance and levels of folate, vitamin B12 and S-Adenosyl methionine (SAMe) can be critical to the methylation cycle and various cellular processes which influence the development, prevention and treatment of various disease states.

Quatrefolic® is also immediately available for use by the cells without the need for any further metabolic transformation. As a comparison and to the contrary folic acid needs to be metabolized to 5-methyltetrahydrofolate to be utilized by the body.

Very little is known and there is an ongoing debate about the metabolism and biological effects of unmetabolized serum folic acid (UMFA) after long term supplementation. There is an increasing evidence that the presence of UMFA may be a contributing factor in safety concerns associated with high intake of folic acid. Folic acid intake does not entirely explain the variability in the presence or persistence of UMFA in the population, suggesting that genetic differences in its metabolism may also be involved. A reduced folate such as Quatrefolic® may benefit certain genetic defects that influence folate metabolism.

Gnosis’ history and product line has long been associated with providing solutions for supporting the one-carbon-metabolism. The founders of the company are responsible for the commercialization of SAMe for which Gnosis is still the global leader in innovation and supply.

With Quatrefolic® Gnosis has confirmed its commitment to this essential biochemical pathway and to creating a structured platform of bioactive nutrients for advanced nutrition.

Gnosis Group

With over 20 years of experience in microbial fermentation and an international manufacturing network dedicated to high-quality and proprietary products Gnosis is specialized in manufacturing and sales of fermentation raw materials and natural finished products used in the pharmaceutical, nutraceutical, and veterinary industries. The Gnosis Group includes a European manufacturing network made up of three operating divisions and three commercial operations located in Italy, the USA and China.

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Headquarters &
Innovation Centre:

Gnosis S.p.A.
Via Lavoratori Autobianchi, 1
20832 Desio (MB) - Italy


Gnosis Bioresearch SA
Via Lischedi, 4 6592 Sant'Antonino - Switzerland

Gnosis Bioresearch Srl
Via Pomarico, 75010 Pisticci Scalo
Pisticci (MT) - Italy

Branch Offices:

Gnosis USA Inc.
169 N. Main Street
Doylestown, PA 18901 - USA

Gnosis China
Room 1001, Hong Kong Plaza
(South Tower), 283 Huaihai Middle Rd., LuWan District, 200021 - Shanghai, China


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