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GRAS Notification filed U.S. patent grant update on Clarisoy(TM) development process
GRAS Notification filed U.S. patent grant update on Clarisoy(TM) development process
About this update from Burcon Nutrascience Corporation
[{"type":"text","content":"\n\n\n\nJan. 19, 2010 (Canada NewsWire Group) -- VANCOUVER, Jan. 19 /CNW/ -- Burcon NutraScience Corporation (TSX - BU) (\"Burcon\" or the \"Company\") is pleased to announce today that a formal notification in accordance with the U.S. Food & Drug Administration (\"FDA\") proposed regulation 62FR 18938 has been filed, having determined, based on a review of the data referenced in the notification that Burcon's cruciferin-rich canola protein isolate Puratein(R) and Burcon's napin-rich canola protein isolate Supertein(TM) are Generally Recognized as Safe (GRAS) for their intended use as an ingredient in a variety of food and beverage applications and in addition, that both substances are exempt from premarket approval requirements of the Food, Drug and Cosmetic Act.The notification contains a listing of eight GRAS use categories for the incorporation of Puratein(R) canola protein isolate and Supertein(TM) canola protein isolate into foods and their GRAS use is fully supported by the safety studies and intake exposure calculations provided within the notification. The GRAS determination is also fully supported by a panel of experts whose written concurrence was also provided in the notification.The notice as provided to the FDA contains approximately 1,700 pages of scientific studies, analyses, publications, supporting information and references. The information contained in the notification addresses both the safety of Burcon's cruciferin-rich canola protein isolate Puratein(R) and Burcon's napin-rich canola protein isolate Supertein(TM) as well as the manner in which the substances are produced.The notice is the culmination of thousands of hours of hard work and determination by a multi-disciplinary team that included experts from a wide variety of medical, scientific and engineering backgrounds.\"We are very pleased with the professionalism and scientific rigor with which this filing was prepared,\" said Johann F. Tergesen, President and Chief Operating Officer, adding, \"Formal notification to the FDA that Burcon's Puratein(R) and Supertein(TM) are Generally Recognized as Safe for their intended use marks another milestone in the development of our Company.\"Burcon and ADM chose to pursue GRAS notification for Supertein(TM) canola protein isolate and Puratein(R) canola protein isolate specifically to allow for their acceptance ...