Bio-Extraction Inc., ("BioExx" or "the Company") is pleased to announce that it has completed the self-affirmation process to qualify its specialty canola protein products, Isolexx(TM) and Vitalexx(TM), as self-affirmed GRAS ("Generally Regarded as Safe") for their intended use in various foods and beverages, thus providing a basis for the sale of these products in the United States when commercial production commences in Q1 2010. GRAS is a food safety standard, set and administered in accordance with the regulations of the United States Food and Drug Administration ("FDA") which governs the use of additives, such as the BioExx protein products, in foods and beverages.
"Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive." (Source: http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/default.htm)
Isolexx(TM) is a canola protein Isolate, for use in human food products such as bakery products (bread, rolls, cakes, cake mixtures, cookies, biscuits, crackers, pancakes, sweet pastry, snacks, doughnuts, and pasta), vegetarian food products and meat analogues, nutritional products and protein bars.
Vitalexx(TM) is a hydrolyzed canola protein extract, for use in human food products such as nutritional beverages (protein fortified soft drinks, fruit juices, high protein drinks), and nutritional products and protein bars.
"BioExx is proud of having achieved many key milestones in the past, but few have been more important than that of achieving self-affirmed GRAS status as we have today," said BioExx CEO Chris Carl. "Now that the entire company has been geared toward becoming the world's first commercial producer of canola protein isolates, obtaining self-affirmed GRAS was a critical requirement to be able to sell the products in the initial target market of the United States. Achieving this milestone in the time period that we have is also a testament to the exceptional work being conducted by our Vice President, Samah Garringer, and her entire team."
The self-affirmed GRAS status was obtained as a result of a detailed process that required a thorough review of both the manufacturing process and the resulting chemical profile of each product by independent and qualified experts in the fields of toxicology and allergenicity. The GRAS review was completed by Keller and Heckman LLP based in Washington D.C., whose comprehensive food and drug practice is one of the largest in the world, having represented companies in front of the FDA in matters such as this for more than 40 years.
The confirmation received today is specific to the Brassica juncea variety of canola, which contains several specific properties that are highly desirable to BioExx including higher than normal protein content in the seed, and a non-GM ("genetically modified") status. The more conventional canola variety, Brassica napus, requires a separate self-affirmation which BioExx may pursue in due course but this is not expected to be required for production at either the current Saskatoon plant or the planned Minot, North Dakota plant.
With the achievement of this major milestone, BioExx now has the basis to be able to sell Isolexx(TM) and Vitalexx(TM) in the United States without obtaining additional approval from, or notification to, the FDA. BioExx is comfortable that the US protein food ingredients market is sufficiently large that its protein products may be absorbed there without difficulty, especially given that the US market is reported to be approximately $4.3 billion annually, and comprises almost a quarter of the entire world market. In the immediate term, attaining self-affirmed GRAS status also has the impact of drawing the attention of a very wide customer audience for the proteins that BioExx will soon be producing.
BioExx will require similar, but separate food safety certifications and possible government approvals or notifications for the sale of its protein products in other jurisdictions, including Canada and Europe, and thus has begun the certification process in both. Keller and Heckman LLP, together with its Brussels office, will assist BioExx in these efforts.
About Bio-Extraction Inc.
Headquartered in Toronto, Canada, BioExx is a leading technology and industrial processing company focused on the extraction of oil and high-value proteins from oilseeds for the global food, beverage, and nutrition markets. BioExx's patented technology allows for the use of significantly lower temperatures than conventional methods in extracting the active ingredients and oils from oilseeds, resulting in higher yields and higher-quality meal, oils and proteins. BioExx's low energy requirements, environmentally sound process, and high-yield production have the potential to make a valuable contribution to global food and protein markets. BioExx operates a commercial scale extraction facility in Saskatoon, Saskatchewan, and has a mission to construct additional and larger processing facilities on a global basis. To find out more about Bio-Extraction Inc. /quotes/comstock/11v!bxi (CA:BXI 1.94, 0.00, 0.00%) , please visit www.bioexx.com
"The statements made in this press release include forward-looking statements that involve a number of risks and uncertainties. These statements relate to future events or future performance and reflect management's current expectations and assumptions. A number of factors could cause actual events, performance or results to differ materially from the events, performance and results discussed in the forward-looking statements, such as the economy, generally, competition in its target markets, the demand for BioExx's products, the availability of funding, the efficacy of its technology, and the anticipated costs of BioExx's plant construction and operation. These forward-looking statements are made as of the date hereof and BioExx does not assume any obligation to update or revise them to reflect new events or circumstances. Actual events or results could differ materially from BioExx's expectations and projections."