On November 24th, the Minister for Medical Care (The Netherlands) sent an Official Notice to Gnosis with the approval for the placing of Chondroitin Sulfate (Mythocondro®) on the market in the EU pursuant to Regulation (EC) No. 258/97 Article 4.2 first indent.
Gnosis SpA in Desio, Italy, may market Mythocondro®, the Non-Animal Chondroitin Sulfate (CS) of fermentation origin, in the European Union as a Novel Food Ingredient to be used in food supplements as defined in Directive 2002/46 / EC on the approximation of the laws of the Member States relating to food supplements. This opens the door to the commercialization of Mythocondro® from Gnosis, in the overall EU.
This key milestone is part of the global strategic plan of Gnosis that started in the USA with the granted GRAS Status of Mythocondro® and the commercialization of the first products with the novel ingredient, in 2017.
With this act, the entire process of registration of Mythocondro® in EU is closed and, starting from the beginning of 2018, the first supplements with the only vegetarian and vegan Chondroitin Sulfate will get finally the EU market.
“This achievement represents an important step forward for our company that has strenuously believed in this project since its beginnings. Even more Mythocondro® represents a huge and long waited step forward for the entire global chondroitin market, always hovering between the clinical value of this is active ingredient – widely established by a large number of human trials with quality-controlled CS – and the serious concerns about the quality of the raw materials commercialized.” – said Marco Berna, Business Development Director of Gnosis.
He said again: “Today, within the nutraceuticals industry, CS is acknowledged as one of the most adulterated supplements in the market. Mythocondro® promises to change entirely the CS market, because it is the first Non-Animal Chondroitin Sulfate obtained through a fermentation-based manufacturing process, developed and patented by using a pharmaceutical approach, ensuring strict quality standards and providing a reliable and reproducible source of CS, able to definitely solve concerns related to poor quality of animal derived CS.”