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1 Silliker, a Mérieux NutriSciences Company, and the Allergen Control Group Present: Gluten-Free Labeling & Risk Management THANK YOU FOR JOINING US! WE WILL START THE WEBINAR MOMENTARILY

2 Silliker, a Mérieux NutriSciences Company, and the Allergen Control Group Present: GLUTEN-FREE LABELING & RISK MANAGEMENT March 11, 2015

3 AGENDA 1. Introduction of Speakers and Companies SECTION 1: GLUTEN OVERVIEW 2. Gluten Market Overview Metrics/ Statistics 3. Drivers Regulations Celiac Associations SECTION 2: GLUTEN MANAGEMENT & CERTIFICATION PROCESS 4. Gluten Management What Is Industry Currently Doing? Advantages to Certifications Holistic Approach: Multi-faceted 5. Certification Process Certification Process Purpose and Deliverables SECTION 3: TESTING 6. Testing Testing Methodologies Swab/ Sample Techniques Sample Submittal Size Shipping- Test Within 24 hours What Happens at 3rd party lab SECTION 4: GFCP AUDIT 7. GFCP Audit Preparation What to Expect Annual Audits Audit Approval by GFCP

4 Introduction SPEAKERS & COMPANIES Frank Massong, VP Regulatory & Technical Services at ACG Allergen Control Group Inc. (ACG) represents a team of food industry experts who understand how to manage manufacturing risks, while maximizing procurement and marketing opportunities. ACG manages, administers, and markets the Gluten-Free Certification Program in partnership with North America s leading celiac organizations, the Canadian Celiac Association and the National Foundation for Celiac Awareness. John Szpylka, Scientific Affairs Director, Chemistry North America at Mérieux NutriSciences With an international network of over 45 laboratories in 18 countries, Silliker is the historical pillar of Mérieux NutriSciences. Silliker, is a leading accredited provider of food safety, quality and nutrition services. Kim Onett, Director of Audit Services at Silliker Silliker Global Certification Services, a subsidiary of Mérieux NutriSciences Corporation, is accredited through the Joint Accreditation System of Australia and New Zealand (JAS-ANZ) to provide certification audits around the globe.

5 Section I: GLUTEN OVERVIEW

6 Metrics/ Statistics GLUTEN-FREE MARKET "Gluten free" is the fastest growing food intolerance category Market for gluten-free foods has seen tremendous growth over the past 5 years (26% over the past 5 years) This market has strong growth potential in coming years North America contributes about 59% of the share U.S. is the largest and fastest-growing gluten-free market

7 Metrics/ Statistics GLUTEN-FREE MARKET In Canada the market for Gluten-Free products was estimated to be $90 million in 2013 with a 10% growth of gluten-free sales until 2018 with a value of $145.2 million. Source: Wellness Trends, The Great Transformation, 2010 report, The Hartman Group Inc. In the US the market for Gluten-Free products was estimated to reach $8.8 billion in 2014, representing an increase of 63% from 2012 All gluten-free food segments grew in the past year with snack sales rising 163% in two years to $2.8 billion. This jump can be attributed primarily to a dramatic 456% increase in potato chip sales. The second-largest gluten-free category was meats/ meat alternatives, which reached $1.6 billion in 2014, a 14% increase from 2012 to Bread products and cereals also saw considerable growth, at 43%, and that category is set to reach $1.3 billion this year. Source: Gluten-free Foods-US, September 2014, Mintel

8 Metrics/ Statistics GLUTEN-FREE MARKET There are an estimated 2.3 million Canadians and 25 million Americans requiring gluten-free products for medical reasons. Celiac disease is on the rise- 4x more common today than is was in the 1950s. It is expected to double every 15 years 71% of consumers buy at least some gluten-free food/ beverage products & 51% will continue to purchase Gluten-Free consumer inquiries are the second most requested ingredient question for retailers & food service establishments The Halo Group: Family members of those suffering as well as those seeking a gluten-free diet for its health benefits adds approximately 7 million Canadians and 70 million Americans to the total number of consumers looking to buy gluten-free products.

9 Metrics/ Statistics GLUTEN-FREE MARKET Approximately 9 Million Canadians and 90 million Americans Are Eating Gluten-Free 22% Gluten avoiders 6% Gluten-sensitivity 1% Celiac Disease

10 Metrics/ Statistics GLUTEN-FREE MARKET Google Trends: Gluten (February 2015)

11 An overview of the REGULATIONS There is no cure for people suffering from celiac disease and gluten sensitivity. The only treatment is to adhere to a strict gluten-free diet for life which, up until now, has been difficult. Due to rapid growth in gluten-free products sectors, errors are made by manufacturers (e.g. mislabelling, cross-contamination and co-mingling of ingredients) Because of failures consumers get sick or sicker and lose trust in products considered and claimed to be gluten-free Government regulators are trying to respond to improved consumer protection

12 An overview of the REGULATIONS Governments world-wild recognize the concerns and suffering of persons from celiac disease and gluten sensitivity by regulation and enforcement strategies Canada- new regulations in August 2012 for gluten-free claims and undeclared wheat and gluten addition without a gluten-free claim USA USFDA published a rule which came into effect in August 2014 Though similar in many cases, the definition of gluten-free and/ or associated regulations and enforcement policies vary between countries and generally government enforcement have been limited by resource constraints.

13 An overview of the REGULATIONS Definition (Canada and USFDA) Any gluten protein from the grain of any of the following cereals (or hybridized strain of at least one of the following): Barley Oats (Canada only and is under review) Rye Triticale Wheat OR any modified gluten protein (or protein fraction) derived from any of the above cereals or hybrid

14 An overview of the REGULATIONS Similarities: Gluten-free is treated as a voluntary claim Virtually the same definition for gluten-free Enforcement is lumped under misbranding but limited Same threshold of <20 ppm of gluten and recommend similar 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

15 An overview of the REGULATIONS Differences: USA allows oats whereas Canada does not (allowing oats is under review in Canada) Canada requires that gluten-free products be handled as special dietary food. USFDA does not Canada has only one regulatory enforcement body whereas the USA has three autonomous bodies (USFDA, USDA and Alcohol and Tobacco Trade and Tax Bureau (TTB) which have slightly different rules and enforcement strategies

16 An overview of the REGULATIONS The Problem: The Canadian Celiac Association (CCA) and the National Foundation for Celiac Awareness (NFCA) represent persons with celiac disease and gluten sensitivity (medical issues) They lobby governments to do more to reduce the suffering (medically and financially) There is no cure for celiac disease and the only treatment is a strict gluten-free diet Too often there are failures in products where gluten is not declared in the list of ingredients and even those claimed to be gluten-free Consumer trust in industry compliance and government enforcement is lacking Shopping takes 2-3 times longer and products are 50% to 100% more expensive 76% of these consumers prefer certified products over self-declarations for added trust

17 Section 2: GLUTEN MANAGEMENT & THE CERTIFICATION PROCESS

18 Gluten Management WHAT IS INDUSTRY DOING? The Solution Over a 5 year period of consultation with food industry experts, consumer groups and government stakeholders developed the Gluten-Free Certification Program (GFCP) and launched it in May 2011 Requirements are based on independent 3 rd party audits of globally recognized preventative, food-safety approaches for managing the production of gluten-free products and not solely on end-product testing. (HACCP-based and GFSI compatible) Designed to meet or exceed Canadian and USA regulations for gluten-free claims. Provides an easily identifiable and trustworthy trademark at point of purchase for consumers to more easily shop with confidence and ease.

19 GFCP Program ADVANTAGES Linkage to internationally recognized robust, food safety management system approaches Reduce business risk and cost of doing business Facilities can easily build on existing and proven food safety systems approaches (compatible with HACCP/ GFSI and ISO requirements) Common tools and program support are made available to participants (e.g. facilities and certifying bodies) Enabling easier flow of both finished product and source ingredients across the US/Canadian border as well as global access Offers a targeted marketing channel with the CCA and NFCA for national and private brands to better engage the gluten-free consumers at home and at the point-of-sale

20 GFCP Program STATUS Applications & Certifications 150+ Certified Brands Products 130+ Recognized facilities to date Product Categories Auditors & CB s 10 Certification Bodies 150+ Approved Auditors 6 Continents Facilities Audited In Fresh / Frozen Bakery Snack Food / Energy Bars Dairy-Free Cheese Dry Goods / Mixes/Spices Meat & Poultry Alcoholic Beverages Pharmaceuticals Cereals etc. United States Canada New Zealand Sweden Switzerland Australia India Italy China Czech Rep. Romania Germany Ireland Thailand Bolivia Mexico etc.

21 GFCP Program CERTIFICATION STEPS Apply to the Program Obtain GFCP Documentation Sign your Program License Agreement Determine License Fees Define Products Prepare and Schedule your GFCP Audit Stand Alone Combine with GFSI/HACCP Approved Auditing Companies Use the GFCP Trademark Trademark Mandatory on Consumer Packages Approve Artwork Samples

22 GFCP Program CERTIFIED BRANDS

23 GFCP Program PURPOSE AND DELIVERABLES Communicates to the consumers at point of sale that the brand is safe and builds sustainable trust and brand loyalty Reduce business risk and costs Consumers want 3 rd party certified products over selfdeclarations Differentiates from other gluten-free claims and certification by partnering with the leading national celiac organizations in Canada (CCA) and the USA (NFCA). Access millions of consumers through your product/ brand listing on the CCA, NFCA and GFCP websites and social media outlets Take advantage of collaborative marketing opportunities at the national, regional and local levels

24 Gluten-Free RESOURCES Allergen Control Group Gluten-Free Certification Program National Foundation for Celiac Awareness Canadian Celiac Association USFDA uidancedocumentsregulatoryinformation/ Allergens/ucm htm Canadian Food Inspection Agency 61

25 Section 3: TESTING

26 An Overview of ANALYTICAL TESTING Analytical test results are only as good as the sample being tested and the reliability of the analytical test

27 Testing Overview OBTAINING SAMPLES Have you ever gone to the beach and stuck your hand in the sand? Most of the time you pull out just sand. Sometimes you find a bottle cap or a shell. Testing for gluten is similar since the proteins or peptides can be located in hot spots. These hot spots do add to the likelihood of locating their presence.

28 Testing Overview SAMPLES FOR TESTING To best evaluate a truckload of grain or a finished product for gluten, the sampling scheme needs to best represent what is being tested. Multiple samples should be collected: at different spots in the truck (top/ middle/ bottom/ more?) at different times during production (beginning/ middle/ end) Especially after a changeover or clean-out Some industries use the same protocols as published for allergens or for microbiological sampling. Test either the collected samples: individually to identify where the hot spot is located, or as a composite sample which is less expensive Note: depending on how hot the hot spot is and how many samples are composited, this could dilute present gluten below what can be measured by any analytical method.

29 Testing Overview SWABS Swabs are used to look for gluten present on surfaces Assesses if a clean-out or a line-changeover was performed correctly. Each company sets up their own protocol to swab surfaces Number of swabs: swab each area exposed to allergen containing materials. Some watch-out areas are joints in conveyor belts, turns & seams in piping, and other areas where product can be captured or experience restricted flow. Area swabbed: typical swab areas are 2 x 2 (25 cm2) or 10 cm x 10 cm (100 cm2)

30 Testing Overview SAMPLE COLLECTION Testing for gluten can be performed quickly, thus allowing proper business decisions to be made Samples can be either tested on site or by an independent lab Testing on site: Quick results possible Testing must be performed by trained analysts in a room with no possible crosscontamination Testing at an independent lab: Samples sent to or picked up by the lab the same day they are collected Recommend 50g 100g sample sizes Swabs: testing can be completed in 24 hrs Ingredient & food samples: testing can be completed in 2-3 days Independent labs have quality assurance protocols to assess method performance and method reliability

31 Testing Overview GLUTEN TESTING Several analytical methods are available to test for gluten Methods look for and may measure gliadin which is ~50% of gluten. Gluten results are therefore 2X the level of measured gliadin The most common analytical method for gluten testing is R5 Sandwich ELISA (Enzyme- Linked Immunoabsorbant Assay). ELISA methods provide quantitative results Lateral-flow devices test for gluten being present above a defined threshold level (may provide semi-quantitative results) Some less-used methods include Polymerase Chain Reaction (PCR) to detect the presence of DNA instead of the protein Adenosine Triphosphate (ATP) swabs are used to evaluate surface cleanliness NOTE: Hydrolyzed or fermented foods/ingredients may have broken down proteins to smaller parts (peptides) that are not measured by sandwich ELISA. There are Competitive ELISA kits available that measure these peptides. Be sure the correct test is being used for your product!

32 E Y E Y Testing Overview ELISA USING MICROWELLS E Y Y E Detection Antibodies Substrate Microwell on a 96-well test plate Capture Antibodies Y Y Y Y Y 3

33 Section 4: GFCP AUDIT

34 Audit Preparation and Planning FIRST STEPS Obtain the GFCP Manual and the Standards and Policies document Determine scope and identify products to be included on Schedule A document Identify Gluten-Free Management System team members Obtain training for team leader and team in applicable regulatory and GFCP requirements Conduct hazard analysis identifying Gluten as chemical risk Identify control points, monitoring, and verification and validation Determine corrective actions when limits are exceeded or requirements are not met

35 Audit Preparation and Planning NEXT STEPS Conduct a gap analysis of current food safety management system programs against the GFCP manual requirements utilizing the self evaluation checklist. Improve or put in place written programs needed to manage the process. Determine training needs of employees involved in control steps and pre- requisite programs. Identify internal audit program to ensure continued compliance and successful implementation of gluten control or exclusion programs. Ensure all required pre requisite programs are in place and include the activities to verify completion and effectiveness Plan method of system review and validation activities

36 Audit Preparation and Planning GLUTEN CONTROL Gluten Control requirements focus on those programs that control the use of ingredients that contain gluten and to prevent or identify the presence of undeclared gluten ingredients in finished food products. Goal is prevention through out the process and procedures in place that address: Purchasing Product formulation control including recipe change management Label approval and control Supplier approval Ingredient specifications Control at receiving Production controls ( blending, batching ) Cross Contamination Controls

37 Audit EXPECTATIONS Audit is in depth and focuses on the process of production and cross contamination potential. Evaluation of veracity of the design of the programs and the level of implementation of those programs in the facility throughout the production process. In plant interview of employees responsible for key points in the production and control process Review of programs and records that support all control programs Gluten control/risk assessment Traceability/Recall Supplier approval Raw ingredient verification programs Labeling/packaging Change Management and corrective actions

38 Auditor QUALIFICATIONS Auditor Qualifications: HACCP training and ability to demonstrate risk based/process based thinking Completed GFCP auditor training and passed the required exam Worked in the food industry and have audit experience In Addition: Must be registered with a GFCP licensed certification body Maintains a satisfactory performance in audits performed File review process of audit reports Proper assignment of level of non conformity Conducted only by Certification bodies accredited to ISO with annual audits required

39 Audit PROCESS Audit can be conducted with a GFSI recognized scheme audit or as a stand alone audit. All clause requirements are rated as Pass or Non conform If all requirements are not met rating is nonconforms and full compliance must be achieved through corrective actions. Auditor will review records of: Production and production scheduling Raw material acceptance procedures Sanitation change- overs Label approvals or changes to labels Employee training Verification activities and validation documents

40 Audit FINDINGS AND REPORT The audit report is designed to facilitate reporting of the effectiveness of the site s food safety management and Gluten control management. Non conformances are discussed at the time of identification and reported on non conformance summary then reviewed at closing meeting. There are three sections of the audit report: 1. Company Profile 2. Audit Checklist 3. Summary Report

41 Audit FINDINGS AND REPORT Section 1 Company Profile Site details, Audit Scope and Food Sector Category Section 2 Audit Checklist Includes program requirement and guidance including clause numbers Divided in to requirement and sub requirements aligned with GFCP manual. Auditor records pass or non conformance Detailed observations and evidence to support decision are recorded in the report Guidance notes are included in the checklist to assist both auditor and site but does not preclude the use of GFCP manual as audit criteria Checklist includes both food safety, management system requirements and Gluten control requirements

42 Audit SUMMARY REPORT/NON CONFORMANCES Section 3 Summary Report Status for each requirement ( 1, 2, & 3 ) Non conformance summary Requirements for Closure of Non Conformances Close out of non conformances in 28 days following completion of audit. Evidence ed to auditor for review and inclusion in final report Report Review by Certification Body Auditor submits final report with all corrective actions and lists an initial recommendation Certification Body Technical reviewer conducts in depth report review including adequacy of close out of corrective actions

43 Audit CERTIFICATION PROCESS Final Steps: CB conducts technical review and final sign off on certification recommendation. Full completed report with all evidence of corrective actions is sent to GFCP for review of recommendation GFCP forwards official certificate of recognition number to the Certification Body Manager Certification Body issues final report and Certificate of Recognition to the site with a validity of one year. Brand owner then permitted to use the GFCP trademark GFCP approves brand packaging artwork per product listed in Schedule A

44 Section 5: CONCLUSION

45 Thank you! QUESTIONS Frank Massong, VP Regulatory and Technical Services, Allergen Control Group Inc. Office: ext. 224 John Szpylka, Scientific Affairs Director, Chemistry North America Office: Kim Onett, Director of Audit Services, Silliker

46 WANT TO LEARN MORE? Register for our upcoming Allergen Program and Gluten-Free short courses and use the promotion codes provided to receive 15% off the registration fee! Date Course Promo Code March 31, 2015 April 1, 2015 Allergen Program Development in a Food Plant allgn0315 April 2, 2015 Gluten-Free Training Program* glutf0315 March 31, 2015 April 1, 2015 COMBO COURSE: Allergen Program Development with Gluten-Free Training allgn0315 Visit for agendas and to register! *Silliker and Allergen Control Group have joined to sponsor a one-day Gluten-Free Training Program.