The Vancouver-based company has been developing the patented ingredients for the best part of a decade but commercialization awaits, although it says the GRAS filing will advance negotiations with firms who demand more than self-affirmed GRAS.
Burcon’s 1700-page GRAS dossier that addresses safety and production issues seeks authorization (or to be precise, FDA non-objection) for Puratein and Supertein in eight food categories this publication was trying to affirm at the time of publication.
The eight categories are meal replacement/nutrition bars; protein supplement powders; salad dressings; fruits and vegetable juices; beverages; grain products; processed meats; dairy products; powdered egg/egg substitutes.
Burcon noted that while self-affirmed GRAS could allow it to enter the ingredients onto market, major food and beverage makers sought FDA GRAS, hence “self-affirmed GRAS status is insufficient”.
Burcon announced self-affirmed GRAS (generally recognized as safe) for Puratein and Supertein back in October 2007, but FDA GRAS notification is often demanded by potential customers.
It is expected the FDA may respond within 180 days.
"We are very pleased with the professionalism and scientific rigor with which this filing was prepared," said Johann F Tergesen, Burcon president and chief operating officer.
Because the proteins may also be used in meat applications, Burcon said it expected the application to be reviewed by the US Department of Agriculture in addition to the FDA.
It also received an ‘Oilseed Meal Preparation’ patent from the US Patent Office, bringing to 12 the number of patents it holds for flax and canola processing and applications.
The company has applied for about 70 patents.
“…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," Tergesen said.
The company is also advancing negotiations for its soy extract, Clarisoy, and was in discussion with “major plant protein producers, dairy protein ingredient companies and other entities”. Burcon already has a confirmed partnership with ADM, but Tergesen told NutraIngredients-USA.com that no other potential partners could be named.