MYTHOCONDRO®, the only vegetarian chondroitin sulfate, gains Novel Food EU Approval

DESIO, Italy – November, 12th 2017

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 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. 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 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.

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*

    *Bauerova K. et al, Pharmacology 2014

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