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."
Neither TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
Contacts: Bio-Extraction Inc. Chris Schnarr Chief Financial
Officer (416) 588-4442 x111 cschnarr@bioexx.com Investor Relations:
Scott Koyich President, Brisco Capital Partners (403) 262-9888
scott@briscocapital.com
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