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 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 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 commercialisation 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 commercialisation of the first products with the novel ingredient, in 2017. Mythocondro is the first Non-Animal Chondroitin Sulfate (CS) obtained through a fermentation-based manufacturing process providing a reliable and reproducible source of product. Mythocondro solves any concerns related to the production origin, the possible presence of transmissible infective agents, the contaminations and adulterations typical of animal-derived raw materials and promises to completely change the global CS industry.
With this act, the entire registration process 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.
Innovation of Mythocondro point-by-point:
- low molecular weight and homogeneous structure similar to human chondroitin, found in synovial fluid
- produced by a natural, green and protected fermentation process: Non-Animal production
- level of use lower than those of animal CS, due to the increased bioavailability
- demonstrated biological activity and established safety profile with published clinical trials
- vegetarian and vegan alternative for people with dietary and religious restrictions
- increased anti-inflammatory effect compared to animal Chondroitin Sulfates
Enna Industrial Ingredients is the South African agent for Gnosis.