BioExx Achieves Self-Affirmed GRAS Status for Protein Isolates
November 18 2009 - 3:02PM
Marketwired Canada
Bio-Extraction Inc. (TSX VENTURE:BXI) ("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. (TSX VENTURE:BXI), 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."
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