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Gluten-Free Certification
“Start Clean-Stay Clean”
Presented by:
Paul Valder, President & CEO
Allergen Control Group Inc.
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The Allergen Control Group Inc. owns,
manages, administers, and markets the Gluten-
Free Certification Program in partnership with
the endorsements from the leading North
American celiac organizations, Beyond Celiac
and the Canadian Celiac Association.
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The Market
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Setting the Stage
Approximately 90 Million Americans and 9 Million Canadians Are Eating Gluten-Free
22% Gluten “avoiders”
6% Gluten-sensitivity
1% Celiac
Disease
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What Is Celiac Disease?
§ Serious genetic autoimmune disease
§ Triggered by consumption of gluten
§ Immune system attacks lining of the small
intestine, affecting absorption of nutrients
§ Left untreated, can develop further
complications:
§ Other Autoimmune Diseases
§ Osteoporosis
§ Metabolic and Neurological Disorders
§ Thyroid Disease
§ Cancer
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Fastest Growing Free From
Category-2009
Google Trends. Julia Belluz. vox.com
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Fastest Growing Free From
Category-2011
Google Trends. Julia Belluz. vox.com
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Fastest Growing Free From
Category-2015
Google Trends. Julia Belluz. vox.com
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U.S. Retail Sales of Gluten-Free Foods
U.S. Retail Sales of Gluten-Free Foods in Key Categories
Sales ($M) % Chg
2015
$1,233 20%
2014
973.2 20
2013
810.8 48
2012
547.6 42
2011
385.1 27
2010
303.5 --
Packaged Facts, Gluten-Free Foods in the U.S. (January 2015)
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U.S. Retail Sales of Gluten-Free Foods
Source: Packaged Facts, Gluten-Free Foods in the U.S. (October 2016)
Category 2011 2015
2011-2015
CAGR
2015
% increase
Baking Mixes $32,004 $85,946 28% 12%
Fresh Bread 25,744 153,302 56 2
Cold Cereal 19,171 86,575 46 23
Crackers 53,777 158,586 31 4
Flour 11,974 36,541 32 -1
Fz Bread/Dough 15,922 18,205 3 15
Cookies 28,882 73,092 26 2
Pasta 34,721 101,276 31 5
Salty Snacks 126,040 539,276 44 20
Total $348,235 $1,252,799 38% 11%
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“Gluten-Free Consumer Survey”
Conducted by Beyond Celiac in Sept 2016
9%
44%
47%
Not Important At All
Somewhat Important
Very Important
How important is third-party certification in your buying decisions?
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Regulations
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What is Gluten?
Definition (USFDA and Canada)
§ Any gluten protein from the grain
of any of the following cereals (or
hybridized strain of at least one of
the following):
§ Barley
§ Rye
§ Triticale
§ Wheat
§ OR any modified gluten protein (or
protein fraction) derived from any
of the above cereals or hybrid
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USFDA & Health Canada Regulations
Similarities
§ Gluten-free is treated as a voluntary claim.
§ Enforcement is lumped under “misbranding”
but limited.
§ Same threshold of <20 ppm of gluten and
recommend similar AAOC testing methods.
§ Disallow intentional addition of gluten
ingredients into gluten-free products. (Note:
contamination is not an ingredient)
§ Encourage management systems approach
for control of gluten contamination vs.
relying on product testing.
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Food Allergens, Gluten & Added Sulphites
§ The CFIA enforces Health Canada's labelling laws and works with
associations, distributors, food manufacturers and importers to
ensure complete and appropriate labelling of all foods. The CFIA
recommends that food companies establish effective allergen
controls to minimize the potential for allergic reactions.
§ Enhanced labelling requirements for food allergen, gluten sources
and sulphites came into force on August 4, 2012.
§ Added food allergens, gluten and sulphites must always be declared
in the list of ingredients or "Contains" statement, to indicate they are
present and must describe their prescribed source names.
§ contamination from sulphites at levels of 10 ppm or more in the
finished product triggers sulphites to be declared in the list of
ingredients or as a "Contains sulphites" statement.
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USFDA & Health Canada Regulations
Differences
§ Canada requires gluten-free products be handled as special dietary
food.
§ Canada has one regulatory enforcement body, Canadian Food
Inspection Agency (CFIA), USA has three autonomous bodies,
USFDA, USDA and Alcohol and Tobacco Trade and Tax Bureau
(TTB)
§ Canada requires products containing oats to be “specially
processed” and must be called-out on the label as ”gluten-free oats”.
§ Canada deems undeclared allergens, gluten & sulphites to be “free-
from”.
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What’s the Problem?
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Allergens #1 Cause of Recalls
Canadian Food Inspection Agency
Together, account for 18% of all
allergen recalls in 2014-15
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Recalls
http://glutendude.com/not-gluten-free/the-gluten-free-cheerios-recall/
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Other Gluten-Free “Claims”
Gluten-Free
Certification
Organization
(GFCO)
Product Certification
<10-ppm testing
Oats OK
Emphasis on end-
product testing
Claim annual onsite
inspection
QAI-NSF
Product certification
< 10-ppm testing
Oats ok
Annual compliance
monitoring
Celiac Support
Association (CSA)
Product certification
<5-ppm testing
No Oats
No onsite presence
Emphasis based on
end-product testing
The Association of
European Coeliac
Societies (AOECS)
Annual onsite inspection
Depends heavily on end
product testing.
Gluten-free oats ok
35 member countries
use established
standards to fit the
requirements in their
own country.
Self Declaration
No 3rd party gluten-
free verification
Limited government
“policing”
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Confusing Consumer Claims & Varied
Product Risk
Test Based Protocol
Test Based Protocol
Test Based Protocol
Management System
“Is your brand marketing team missing a lost opportunity?”
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SUMMARIZING THE PROBLEM
§ Consumers who require gluten-free products are
confused by gluten-free label claims
§ Government regulations and gluten-free definitions
vary with limited enforcement
§ Product certification based on testing is unreliable
and costly
§ Risk of product failure and manufacturers liability
§ “Gluten-Free” viewed as a health claim vs. a food
safety requirement
§ Marketers are not leveraging a meaningful brand
message from leading celiac organizations
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A Management System
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The Solution
§ A scientifically proven, risk
based management systems
approach for effectively
controlling gluten and gluten
cross contamination from
incoming ingredients to final
product
§ A standardized set of global
requirements for gluten-free
§ A credible, trustworthy,
endorsed gluten-free
trademark, at the point of
purchase
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Gluten-Free Certification Program
§ The only ISO 17021-1 accredited gluten-free management
system standard, verified by three-party trained food auditors
and certified by licenced certifying bodies
§ Based recognized preventative, food-safety approaches for
managing production of gluten-free products (FSMA Rules &
Safe Food for Canadians Act)
§ Standard designed to meet or exceed global regulations
(non-prescriptive)
§ Combines efficiently with existing food safety systems (i.e.
GFSI, HACCP, GMP’s)
§ Reduce cost and risk of product failure related to
dependence on product testing
§ Provides an identifiable and trustworthy mark for consumers
at point of purchase
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Benefits of a Management System
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Management System Accreditation
§ ANSI-ASQ National Accreditation
Board (ANAB) provides
accreditation services and will
provide additional oversight for
holding certifying bodies
accountable to ISO/IEC 17021-1
management system operating
standards
§ ACG is in consultation with JAS-
ANZ as part of an expansion plan
to provide CB’s with additional
and global accreditation options
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Program Accreditation & Administration
GFCP Trademark
Endorsement
GF Manufacturer /
Brand Owner
Certification Body
Licensing, Training,
Accreditation
License
Agreement
GFCP Audit
Gluten-Free Certification
Program
Owned by Allergen Control Group Inc.
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Strengths & Benefits for Manufacturers
§ Certification for dedicated or non-
dedicated manufacturing facilities
§ Operational efficiencies (combined
audits)
§ Reduced testing costs
§ Reduced likelihood of recall (brand
protection)
§ Expands potential for new business
(e.g. private label)
§ Promotes Corporate Social
Responsibility
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Strengths & Benefits
For Brands
§ On pack consumer trademarks
endorsed with the name of leading
celiac organizations
§ Differentiate your brand by sending a
consistent consumer brand message
§ Gain brand relevancy to millions of
consumers with your product listings on
leading celiac association websites
§ 76% of consumers prefer certified
products over self declarations
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Conclusion
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Summary of Strengths & Benefits
§ Based on stringent, proven food safety systems (compatible with HACCP/
GFSI / FSMA requirements)
§ Reduce the likelihood of recall, by the successful management of gluten
beyond just end product, testing “thresholds”
§ Adaptable for gluten-free in dedicated and non-dedicated manufacturing
facilities (i.e. based on risk)
§ Certification audits conducted globally and by 3rd party, independent auditing
companies following ISO 17021 and ISO 17065 accredited guidelines
§ Builds a trusted supply of certified GF co-packers, and suppliers
§ Expands potential market for private label opportunities and national brand
access to food retailers and food service distribution.
§ Fits with the objectives to satisfy the short and longer term needs of the Food
Safety Modernization Act (FSMA).
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Two Distinct Value Propositions
§ Receive the assurance and credible 3rd party recognition that your
own brand has been produced in a manufacturing facility, which
consistently implements the industry’s most technically advanced
and science-based gluten-free management system.
§ Proudly, associate your brand with exclusive endorsements from
North America’s leading consumer celiac organizations and
augment your brand trust with the important consumer segment,
who depend on a range of safe, reliable and affordable gluten-free
products for life.
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HELPFUL LINKS
§ USFDA
http://www.fda.gov/Food/GuidanceRegulation/
GuidanceDocumentsRegulatoryInformation/Allergens/ucm362510.htm
§ Canadian Food Inspection Agency
http://www.inspection.gc.ca/food/labelling/food-labelling-for-industry/
allergens-and-gluten/gluten-free-claims/eng/
1340194596012/1340194681961
§ Health Canada
http://www.hc-sc.gc.ca/fn-an/securit/allerg/cel-coe/gluten-position-
eng.php
§ Beyond Celiac www.beyondceliac.org
§ Canadian Celiac Association www.celiac.ca
§ Gluten-Free Certification Program www.glutenfreecert.com
§ Food Allergy Research & Resource Program http://farrp.unl.edu
§ Gluten Free Watchdog www.glutenfreewatchdog.org
§ INAF www.inaf.ulaval.ca
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Thank you. Questions?
Paul Valder, President
1.866.817.0952 ext. 221
www.glutenfreecert.com