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Emerald Group Publishing Limited
Copyright © 2010, Emerald Group Publishing Limited
Generally Recognized as Safe
Article Type: Food facts From: Nutrition & Food Science, Volume 40, Issue 3.
Vancouver, British Columbia, 2010 – Burcon NutraScience Corporation (TSX – BU) (“Burcon” or the “Company”) is pleased to announce that a formal notification in accordance with the US 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® and Burcon's napin-rich canola protein isolate SuperteinTM 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® canola protein isolate and SuperteinTM 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.
If the FDA is satisfied with the notification, Burcon expects that the FDA will respond with a no-objection letter in accordance with the FDA's established timelines.
Burcon is also pleased to report that a previously announced notice of allowance received with respect to a US patent application has now proceeded to grant as a US patent by the United States Patent and Trademark Office. The US Patent – titled Oilseed Meal Preparation (US Patent No. 7,645,468) covers novel processing conditions in oil seed meal preparation and the production of tailored meals in place of, for example, conventional canola meal. These oilseed meal preparation techniques have a significant impact on the quality of the final protein products including superior taste and improved aroma as well as on the yield obtained through Burcon's protein extraction processes. Burcon now holds a total of 12 US patents which cover canola and flax protein processing technologies and applications.