The certification essentially means that Hygieia's joint health ingredient GlucosaGreen can now be used on the European market for the same purposes as Glucosamine HCL derived from shellfish - that is, in food supplements and foods for particular nutritional purposes (PARNUTS).
Hygieia's GlucosaGreen line includes three different glucosamine salts: d-glucosamine HCl; d-glucosamine sulfate 2KCl; and d-glucosamine sulfate 2NaCl.
It is one of a number of recently-launched non shellfish-derived glucosamines that aim to address the market need for an ingredient suitable for vegetarians, people allergic to shell fish, or those adhering to a Kosher diet.
FSAI opinion Ingredients that have been produced using a different process or extraction method than the regular approved form of the ingredient need to be assessed for their quality and safety.
Achieving substantial equivalency from FSAI means that GlucosaGreen has been demonstrated to be safe in composition, nutritional value, metabolism, intended use and undesirable substance levels, said Hygieia.
The company explained that FSAI's opinion was passed on to the European Commission, which assessed all relevant information to demonstrate substantial equivalency and determines whether the notification is valid or not.
The European Commission confirmed to NutraIngredients.com that further to its assessment, Hygieia can now place its GlucosaGreen on the market for use in supplements.
Hygieia claims that further to the certification, it is now one of the only suppliers of vegetarian glucosamine "which may be legally used in the EU."
NutraIngredients.com was unable to confirm in time for publication.
"Gaining this equivalency not only proves product safety, it provides a significant market edge, expanding applications as well as opportunities.
What's more, it sets precedence for further penetration throughout the EU food supplement markets," said David Corcoran, Hygieia's marketing manager.
GlucosaGreen Glucosamine has been found to rebuild cartilage, and is therefore considered one of the major joint health ingredients.
It is often used in conjunction with chondroitin, which gives cartilage elasticity.
According to Corcoran, joint health has been a major area of focus for the company since it was formed in 2005.
The firm developed its own glucosamine ingredient in response to interest from customers, who were looking to differentiate their brands.
Hygieia told NutraIngredients-USA.com that a major benefit of its GlucosaGreen product is its guaranteed purity, which means it does not contain the residual impurities that can be found in alternative sources.
This allows dietary supplement manufacturers to use the ingredient in tablets without the need for coating - which is often used to obtain an aesthetically pleasing white-looking tablet.
However, GlucosaGreen is a naturally white crystalline product, and can therefore save manufacturers the cost and the extra production step necessary for coating, said Corcoran.
The company, which is based in China but conducts all of its sales outside of the country, said its whole manufacturing process and quality assurance program have been modeled on ICH guidelines - a standard of reference used by the pharmaceutical industry.
Its manufacturing facility, which was completed at the end of 2007, is self-certified CGMP (Current Good Manufacturing Practice).
Hygieia would not reveal the source of its ingredient, nor its price range.
However, it claimed GlucoaGreen is "cheaper than all the alternate vegetarian glucosamines on the market at present," including competitive Chinese production.
Other vegetarian glucosamines on the market include Cargill's Regenasure, derived from the fungus Aspergillus niger, and Cyanotech's JointAstin.