1 October 2009 - Dyadic International has completed the US Food and Drug Administration's (FDA) GRAS notification process for its C1-derived cellulose enzyme.
The company said it has received acknowledgement from the US FDA that it has no questions at this time regarding Dyadic's conclusion that the cellulose enzyme preparation derived from a genetically modified strain of its C1 organism is generally recognised as safe (GRAS) under the intended conditions of use.
The FDA based its notification (GRAS Notice GRN 000292) on information provided by Dyadic as well as other information available to the FDA.
Dyadic followed FDA-proposed procedures to establish that its C1-derived cellulase enzyme is GRAS.
This process included convening an expert panel to review the necessary product safety data and then submitting a voluntary notification to the FDA of the expert opinion and the data supporting its conclusion.
With this positive development, Dyadic will offer for sale a liquid enzyme product produced from its C1 technology platform called Celustar CL for use in the production of wine, beer and fruit juices.
