January 19/Vancouver, B.C./Burcon NutraScience Corp. — Burcon NutraScience Corporation announced 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 and Burcon’s napin-rich canola protein isolate Supertein 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 Supertein 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.