Regulatory and Intellectual Property

As GRAS assessment declaims, Quatrefolic^® has been rigorously tested for safety and consistency. It is produced under strict quality control procedures allowing Gnosis by Lesaffre 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 a few years of commercialization. Here is a summary of the best-gained recognition of Quatrefolic^®, the innovative folate.

August 2010 USA: GRAS (generally recognised as safe self-affirmation)

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.

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 Annexe II to Directive 2002/46/EC

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 European Community.

August 2016 AUSTRALIA: TGA approval

Quatrefolic^® has been positively evaluated for safety and approved as permitted ingredients 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 authorisation

The National Health and Family Planning Commission of the officially notifies that Quatrefolic^® is publicly authorised 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.

The importance of intellectual property

Intellectual property ensures protection and customer satisfaction. It provides useful and tangible results against « unfair competition », enforcing the value of finished products and allowing to create a positive brand awareness. Intellectual property rights of new dietary ingredients are extremely important both for the inventor and for companies that intend to utilise the product, avoiding infringement of existing patents.

Patents

Quatrefolic^® property rights have been strictly protected by patents pending international applications. The US Application has been granted by the United States Patent and Trademark Office (USPTO) on May 2011. Development of new formulations and combinations with vitamins and minerals is now possible for this revolutionary folate making it an excellent choice for formulations and applications in several market segments.

Trademark

Quatrefolic^® trademark and four-leaf clover logo are proprietary of Gnosis by Lesaffre. and are registered in the United States and other countries. Using Quatrefolic® ensures customers claim exclusive products in the marketplace, through identity and « trade origin » recognition of the new folate derivative. Trademark on the product labels and in advertising materials works as a reference point for the consumers to find reliable information; the distinctive mark allows them to identify the product and link it to expected quality.

Quatrefolic^® and Folate Body of Knowledge

The birth of Quatrefolic^® represents the latest success of Gnosis by Lesaffre in the development of folate derivatives, making it the third product in this field. Gnosis by Lesaffre is the only manufacturer of folate products that can claim three different GRAS status and NDI notifications demonstrating a piece of sound knowledge in the research and development of alternative sources for vitamins. Quatrefolic^® has been granted Kosher by K-OF Kosher Supervision, one of the foremost Kosher certification agencies in the United States, serving the Kosher consumer for almost 50 years.

Intellectual property and folate Body of Knowledge are usually disclosed by Gnosis by Lesaffre to its final worldwide clients. Our technical and commercial teams are available to evaluate specific requests and provide technical documents and scientific studies.