Burcon and ADM File GRAS Notification for Canola Protein Isolates with US FDA

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.

20 Jan 2010 --- Burcon NutraScience Corporation has 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.

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 and Burcon’s napin-rich canola protein isolate Supertein 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 and Supertein 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 canola protein isolate and Puratein canola protein isolate specifically to allow for their acceptance by global food and beverage companies for whom self-affirmed GRAS status is insufficient.

A substance is GRAS-notified when, after reviewing the GRAS notification, the FDA responds with a no-objection letter that it is satisfied with the submission. On occasion, the FDA will consult with other agencies; for example, when a GRAS notification includes use in meat and poultry products, the FDA consults with the Food Safety and Inspection Service of the U.S. Department of Agriculture (USDA). It is expected that, since Burcon’s proteins have potential uses in meat products, the notification will also be reviewed by the USDA.

The FDA is expected to acknowledge the GRAS notification in writing within thirty days. 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 which could take up to 180 days.

Burcon has also reported a previously announced notice of allowance received with respect to a U.S. patent application has now proceeded to grant as a United States patent by the United States Patent and Trademark Office. The U.S. 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 U.S. patents which cover canola and flax protein processing technologies and applications.

“Thanks to the high calibre of the work of Burcon’s scientists and engineers, our patent applications continue to be approved.” said Johann F. Tergesen, adding, “As a result, our patent portfolio continues to broaden from the original core protein extraction and purification technology as we seek to protect all of our extraction processes, applications of our proteins, and even the protein compounds themselves.”

Burcon also updates on the process of pursuing a strategic alliance partner or partners for the development of Burcon’s CLARISOY soy protein isolate. Over the past few quarters, Burcon has been in discussion with certain of the world’s largest protein ingredient companies including major plant protein producers, dairy protein ingredient companies and other entities that have expressed an interest in partnering with the Company. Burcon is pleased with the progression of the discussions to-date and is reviewing due diligence requests as part of that process. The Company will continue to explore all strategic alliance opportunities for the development of CLARISOY. Burcon’s intention is to identify an alliance that is the most beneficial to the Company and with the greatest potential to enhance shareholder value.

“We continue to be encouraged by the interest in our CLARISOY soy protein isolate from potential partners,” said Johann F. Tergesen, adding, “CLARISOY’s combination of nutritional and functional attributes make it truly unique.”