Burcon Announces Publication of Puratein Toxicology Study
To enhance the acceptance of Puratein canola protein isolate and Supertein canola protein isolate with global food and beverage companies, Burcon and ADM have chosen to pursue GRAS notification for Puratein canola protein isolate and Supertein canola protein isolate.
21 Aug 2009 Burcon NutraScience Corporation announced the acceptance for publication of a peer-reviewed manuscript describing a toxicology study of Puratein canola protein isolate. The toxicology study was originally conducted to establish the safety of Puratein canola protein isolate in food and beverage applications and ultimately to support the process of obtaining Generally Recognized As Safe status ("GRAS status") for Puratein in the United States. The manuscript, titled "A 13-week sub-chronic dietary toxicity study of a cruciferin-rich canola protein isolate in rats", has been accepted for publication in the journal of Food and Chemical Toxicology. Publication of this study is an important step in the process of obtaining GRAS notification for Burcon's Puratein canola protein isolate.
The consumption of canola/rapeseed products in the Western world is recent and has been limited to the use of the oil for cooking and in salads and as canola meal in the livestock industry. Burcon's technological advances have made possible the production of canola protein isolates suitable for human consumption as ingredients in higher amounts and in a broader range of foods. Besides their inherent nutritional value and low levels of anti-nutritional factors, Burcon's protein isolates possess unique functional properties such as emulsifying and binding characteristics and transparency when added to beverages. Burcon's two canola protein isolates are rich in either cruciferin or napin, the major canola protein components.
The objective of this study was to evaluate the safety of Puratein (a cruciferin-rich canola protein isolate) when fed as a protein source at various dietary levels to rats for 13-weeks. Luis Mejia, director of scientific and regulatory affairs of Archer Daniels Midland Company ("ADM"), is the primary author of the study. As previously disclosed, the results of the trial confirmed that Burcon's Puratein canola protein isolate - as produced using Burcon's patented technology - is safe for it's intended use in food and beverage applications,
"With the publication of this study we are another step closer to having our canola protein isolates GRAS notified," said Johann F. Tergesen, Burcon's president and C.O.O. "A number of the global food and beverage companies who have entered into material transfer agreements with Burcon to evaluate our canola proteins have indicated their desire that Puratein and Supertein attain GRAS notification."
Scientific studies including toxicology studies evaluating the safety of both Puratein and Supertein were conducted during fiscal 2008 and based on those studies, Burcon and ADM prepared a dossier of data that included scientific information about canola seed, how canola is grown, handled and processed, Burcon's protein extraction process and finally, the intended uses of Puratein and Supertein in foods and beverages. A panel of qualified experts in the fields of food safety, toxicology, nutritional sciences, food allergies and pediatric nutrition reviewed the dossier to which the panel also had input and affirmed unanimously that the proteins are safe for their intended uses. In October 2008, Burcon's Puratein canola protein isolate and Supertein canola protein isolate achieved self-affirmed GRAS status.
To enhance the acceptance of Puratein canola protein isolate and Supertein canola protein isolate with global food and beverage companies, Burcon and ADM have chosen to pursue GRAS notification for Puratein canola protein isolate and Supertein canola protein isolate. GRAS notification is a voluntary procedure whereby a company informs the U.S. Federal Food and Drug and Administration ("FDA") of its determination that the use of a substance is GRAS.
A substance is GRAS notified when, after reviewing the GRAS notification, the FDA responds with a no-objection letter if it is satisfied with the submission.
After pre-consultation with the FDA, Burcon and ADM concluded that they would, prior to submitting the GRAS notification, submit the scientific studies which were incorporated into the GRAS dossier (the toxicology studies) to peer reviewed journals for publication. The subject of today's announcement is the publication in the peer-reviewed journal of Food and Chemical Toxicology of the Puratein canola protein isolate manuscript. Burcon and ADM have also submitted the toxicology study conducted for Supertein canola protein isolate to a peer-reviewed journal for publication. Once the Supertein toxicology study is accepted for publication, Burcon and ADM will proceed to submit the GRAS notification for Puratein and Supertein to the FDA.
Burcon and ADM will submit the GRAS notification using information contained in the dossier that has been approved by the panel of qualified experts for the self-affirmation process including the published toxicology studies. Upon receipt of the notification, the FDA is expected to respond in accordance with the FDA's established timelines which could take up to 180 days.
Although Burcon and ADM have determined to pursue GRAS notification to enhance market acceptance of Burcon's proteins, Puratein canola protein isolate and Supertein canola protein isolate are already self-affirmed GRAS and may be marketed and sold for human consumption in the United States.
