Canadian firm Burcon is closer to submitting GRAS notification for its canola protein isolates to the FDA, as a key toxicology study is accepted for publication.
Canola is usually consumed in the Western diet as an oil for cooking or salad dressing, or used in animal feed. Burcon’s proposed uses of its isolates, including as emulsifiers and binding agents, under development for almost two decades, mark a new departure for the second largest oilseed crop (after soy).
Burcon announced self-affirmed GRAS – generally recognized as safe – for its Puratein and Supertein protein isolates in October 2007, after review of evidence by a panel of experts from fields including food safety, toxicology, allergies and pediatric medicine.
But Burcon president and CEO Johann Tergesen said that the companies testing the ingredients, through material transfer agreements, have signalled they are keen for them to have the full GRAS notification, which involves submitting a dossier of safety evidence to the FDA and receiving a no objection letter.
The company stated its intention to achieve GRAS notification at the time self-affirmed GRAS was announced.
The ultimate goal of Burcon and its partner ADM is to have the two products join the competitive soy, dairy and egg protein ingredient market, for use in foods, nutritional supplements and personal care products.
The acceptance of a key rat study on Puratein in the journal Food and Chemical Toxicology is said to strengthen its case. Puratein is rich in cruciferin and is said to be useful for emulsification, gel formation, thickening, formation of heat-stable foams, and water- and ingredient-binding. Applications include dressings, meat substitutes, baked goods and protein bars.
The study, availably online ahead of print, involved feeding the ingredient to rats as a protein source over a period of 13 weeks, at various dietary levels. Body weights, food consumption, locomotor activity and behavioral and clinical pathology parameters were recorded. The animals’ organ weights were then determined, and their tissues examined under microscope.
“There were no test article-related effects on body weight, food consumption, clinical observations, functional observational battery, motor activity, clinical pathology, or ophthalmic examinations,” wrote the researchers.
They saw a no-observed-effect-level (NOEL) of 10 per cent, whereas the no-observed-adverse-effect-level (NOAEL) was the highest fed level of 20 per cent - equivalent to 11.24 g/kg BW/day for males and 14.11 g/kg BW/day for females.
The company has also submitted a toxicology study on Supatein for publication in a peer reviewed journal. Supatein is rich in the other major canola protein component napin and is said to be solubility, to form transparent solutions and to foam. Applications include beverages, confectionery, aerated desserts, and protein bars. Once this study has been accepted, the company will press ahead with the notification.
Both the studies were conducted in fiscal year 2008.
Food and Chemical Toxicology (Elsevier)
Doi:10.1016/j.fct.2009.07.029. Available online ahead of print.
“A 13-week sub-chronic dietary toxicity study of a cruciferin-rich canola protein isolate in rats”
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