What is gluten free certification and its labelling requirements? William Muil Food Programme Manager Welcome everyone and thank you for attending this gluten free webinar.

Regulatory Requirements for Gluten Free Agenda What is Gluten? Impact of Gluten Regulatory Requirements for Gluten Free Gluten Free Certification Process Summary Q&A During our short presentation today I will be discussing the following topics: What is Gluten? What is the impact of Gluten? The regional regulatory requirements pertaining to gluten and gluten free labelling, The steps to achieve gluten free certification of your products I will then summarize the key points for your review and we will have a question and answer session at the end.

“Gluten-free” is defined as <20ppm, (regionally defined) What is Gluten? Gluten” is not a single protein. It is a mixture of: Gliadin (a protein) Glutenin (a protein) Water Gluten is the elastic material that gives cereal dough its structure & enables it to hold gas bubbles in the baking process Gluten is a combination of 2 proteins: Glee add inn and gluten inn. Gluten is the elastic material that give dough it’s structure and allows it to hold gas bubbles which makes the baked goods light and fluffy. Without gluten products are smaller and dense. Gluten-free is regularly defined as products containing <20ppm of gluten. Each Global region can be different so you must check the regulation. Most tests measures the presence of the Glee add inn protein in the product. “Gluten-free” is defined as <20ppm, (regionally defined) Most “gluten tests” test for the presence of Gliadin

Gluten Sources Gluten occurs naturally in: Wheat (including: Durum, Einkorn, Emmer, Faro, Spelt) Barley Rye Triticale (a wheat : rye cross) Gluten may also be found in any material contaminated with a gluten-containing ingredient (e.g. Oats, Corn, Rice when processed on the same equipment as Wheat). Gluten is naturally occurring in Wheat, Barley, Rye and Tri Ti Kale. Gluten may also be present in naturally non-gluten containing products such as Oats, Corn and Rice as a result of cross contamination during processing. These products are typically processed on the same equipment used for the processing of naturally occurring gluten sources.

Naturally non-gluten containing foods Gluten Sources Typical gluten containing foods Bread Condiments Sauces / gravies Canned soup Beer Pickles Lunch meats (processed) Naturally non-gluten containing foods Rice Corn Water Fruits, Vegetables Meat, Fish Milk Salt, Pepper

Non-Celiac Gluten Sensitivity (NCGS) Impact of Gluten Celiac Disease Autoimmune disease triggered by gluten causing impaired ability of small intestine to absorb nutrients leading to bloating, diarrhea, anemia, weight loss, etc. May affect up to 1% of population. Non-Celiac Gluten Sensitivity (NCGS) Non-allergic response to gluten that may cause problems similar to celiac disease (though less severe) or headaches & “brain fogs”. May affect up to 6% of population. Wheat Allergy Classic allergic response to wheat gluten that may lead to breathing problems, hives, rashes & vomiting. May affect up to 1% of population. Gluten has an adverse effect on a small percentage of a population. Celiac disease is an autoimmune disease triggered by gluten that affects the digestive tract of sufferers. There is no cure for Celiac Disease however a life-long gluten free diet has shown to control the symptoms. There is a certain percentage of the population that has shown a sensitivity to gluten with less sever effects then Celiac disease sufferers. Finally, those with a wheat allergy can benefit from consuming gluten free products.

Regulatory Requirements for Gluten Free FDA Regulation 2014 Certain grains are especially likely to contact naturally occurring gluten Applies to all food and beverages Excludes meat, poultry, certain egg products and most alcoholic beverages Gluten limit of <20ppm An ingredient derived from gluten-containing grain can be labelled as gluten free if it has been processed to remove gluten and results in the presence of <20ppm of gluten The Food and Drug Administration states: “Manufacturers that label their products “gluten free” are accountable for using the claim in a truthful and not misleading manner and comply with all FDA regulations” Certain grains are especially likely to contain naturally occurring gluten including wheat, barley, rye and crossbred hybrids like Triticale (oats are permitted in the US). Applies to all food and beverages – including packaged foods, dietary supplements, fruit and vegetables, shell eggs and fish. Excludes meat poultry and certain egg products (regulated by USDA) and most alcoholic beverages (regulated by the TTB). Gluten limit of less <20ppm – no mandate for testing, documentation, verification or validation documentation required. An ingredient derived from gluten-containing grain can be labelled as “gluten free” if it has been processed to remove gluten and results in the presences of <20ppm of gluten.

Regulatory Requirements for Gluten Free Gluten free food does not contain an ingredient that is:: A gluten-containing grain (e.g., spelt wheat) Derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour) Derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch) if there is the presence of 20 ppm or more gluten In general, foods may be labeled “gluten-free” if they meet the definition and otherwise comply with the final rule’s requirements. More specifically, the final rule defines "gluten-free" as meaning that the food either is inherently gluten free; or does not contain an ingredient that is: a gluten-containing grain (e.g., spelt wheat); derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour); or derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food. Also, any unavoidable presence of gluten in the food must be less than 20 ppm

Regulatory Requirements for Gluten Free Canadian Food Inspection Agency Section B.24.018 of the Food and Drug Regulations: It is prohibited to label, package, sell or advertise a food in a manner likely to create an impression that it is a gluten-free food if the food contains any gluten protein or modified gluten protein, including any gluten protein fraction, referred to in the definition "gluten" in subsection B.01.010.1(1). Although Health Canada's regulatory requirements for "gluten-free" foods do not refer to any specific threshold for gluten in products represented as "gluten-free", Health Canada considers that levels of gluten protein below 20 ppm generally do not represent health risks to consumers with celiac disease. Ref: Codex Stan 118-1979 which states that the gluten content of foods labeled gluten free shall not exceed 20 ppm. Based on the available scientific evidence, Health Canada considers that gluten-free foods, prepared under good manufacturing practices, which contain levels of gluten not exceeding 20 ppm as a result of cross-contamination, meet the health and safety intent of B.24.018 when a gluten-free claim is made. The best currently available scientific evidence indicates that levels of gluten below 20 ppm in gluten-free foods would be protective of the health of the vast majority of people with Celiac disease. This level is recognized internationally in the Codex Alimentarius Standard for Foods for Special Dietary Use for Persons Intolerant to Gluten

Regulatory Requirements for Gluten Free a) Any gluten protein from the grain of any of the following cereals or the grain of a hybridized strain created from at least one of the following cereals: barley, oats, rye, triticale, or wheat, kamut or spelt b) Any modified gluten protein, including any gluten protein fraction, that is derived from the grain of any of the cereals referred to in section B.01.010.1. CFIA CFIA Subsection B.01.010.1(1): defines Gluten as: any gluten protein from the grain of any of the following cereals or the grain of a hybridized strain created from at least one of the following cereals: barley, oats, rye, triticale, or wheat, kamut or spelt; or any modified gluten protein, including any gluten protein fraction, that is derived from the grain of any of the cereals referred to above or the grain of a hybridized strain referred to in paragraph Although Health Canada's regulatory requirements for "gluten-free" foods do not refer to any specific threshold for gluten in products represented as "gluten-free", Health Canada considers that levels of gluten protein below 20 ppm generally do not represent health risks to consumers with celiac disease.

Regulatory Requirements for Gluten Free European Commission Regulation (EC) 41/2009 concerning the composition and labeling of foodstuffs suitable for people intolerant to gluten ‘Gluten-free': at 20 parts per million of gluten or less ‘Very low gluten': at 100 parts per million of gluten or less - however, only foods with cereal ingredients that have been specially processed to remove the gluten may make a 'very low gluten' claim. The European Union regulation EC 41/2009 defines the gluten free and labeling requirements. There are 2 label claims that can be made: Gluten Free which is <20ppm of gluten in the product And “Very Low Gluten” which if different from the other regions. This is defined as products having <100ppm of gluten

Gluten Free Certification Process GFCP: Gluten Free Certification Programme ACG (Allergen Control Group Inc.) administers GFCP certification in association with: CCA (Canadian Celiac Association): NFCA (National Foundation for Celiac Awareness): Intertek has a Gluten Free certification program available. It is administered by the ACG (Allergen Control Group) and is endorsed by the CCA (Canadian Celiac Association) and NFCA (National Foundation for Celiac Awareness). Once a facility is certified to Gluten Free a certificate is issued with both logos as a recognition by both associations.

Gluten Free Certification Process GFCP is a voluntary programme developed in consultation with industry and government stakeholders The most widely recognised and accepted gluten free certification standard Promotes the use of Hazard Analysis Critical Control Point (HACCP) principles and a management system Provides a credible and fundamental framework designed to consistently meet and exceed FDA, CFIA and international regulations for gluten free claims GFCP is a voluntary program that continues to evolve in consultation with industry and government stakeholders The most widely recognized and accepted gluten free certification standard. Promotes the use of HACCP principles. Provides a credible framework designed to consistently meet FDA, CFIA and international regulations for gluten free claims.

Gluten Free Certification Process Two types of facility may be audited Dedicated plant audits List of all gluten-free products being certified Gluten-free/quality policy is communicated to staff Gluten-free management system is in place All incoming materials (including packaging) must be gluten-free Non-dedicated plant audits All of the requirements for dedicated plants (above) All cross-contamination risks must be suitably controlled Two types of facilities may be audited: Dedicated facilities where only gluten free products are made. The requirements for this type are: that all gluten free products to be certified are listed on a Schedule “A” document approved by the Allergen Control Group. That a Gluten Free / Quality Policy is communicated to all employees. That a Gluten-free management system is in place That all incoming materials (including packaging) must be gluten-free for non-dedicated facility (both gluten-containing & gluten-free products are being made) require the expectation for the dedicated gluten free facilities plus that all cross-contamination risks must be suitably controlled

Gluten Free Certification Process GFCP Application You must apply to the Gluten Free Certification Programme (GFCP) with the Allergen Control Group (ACG) http://www.glutenfreecert.com/ A signed Programme License Agreement (PLA) outlines the terms and conditions regarding your partnership with the GFCP and lists the products that will be eligible to carry the GFCP trademark. This is the required Schedule “A” document. You will also receive a GFCP registration number.

Gluten Free Certification Process The following information will be required: Copy of Schedule “A” document (if known) Number of employees GFCP Registration Number (if known) GFCP Audit Proposal Gluten free dedicated or non-dedicated facility GFCP Audit Proposal Intertek will need the following: Number of employees Gluten Free dedicated or non-dedicated facility Number of gluten free products in the scope of certification Combined with a GFSI audit or stand alone. GFCP Registration Number (if known) Copy of Schedule “A” document (if known) The GFCP registration number and the ACG signed Schedule “A” must be submitted prior to the start of the Gluten Free audit. A signed audit proposal must be received before the scheduling process is initiated. No. of gluten free products in the scope of certification Combined with a GFSI audit or stand alone

Gluten Free Certification Process The Audit Preparation A pre-audit can be scheduled if desired A “Self-Assessment Checklist” is available from the ACG once you are registered in the Gluten Free Registration programme

Gluten Free Certification Process The Audit Process On-site GFCP assessment: The premises Transportation/Purchasing/ Receiving/Shipping/Storage Equipment Personnel Sanitation and Pest Control Recall Allergen and Gluten Free Control The Audit Process On-site GFCP assessment: The premises Transportation/Purchasing/ Receiving/Shipping/Storage Equipment Personnel Sanitation and Pest Control Recall Allergen and Gluten Free Control

Gluten Free Certification Process Following a successful GFCP audit process and closure of any identified gaps you will be issued a GFCP Certificate of Recognition (COR). The Gluten Free Certificate is valid for one year. An annual recertification is required.

Gluten Free Product Preparation Business decision to manufacture gluten free bread Consider: Suppliers ability to supply gluten free raw materials Mitigation of cross contamination risks internally and within supplier process Validation of change over with shared equipment Employee training Applicable regulations in region of sale Finished goods testing to confirm gluten threshold ie: <20ppm If your organization decides to enter the gluten free market the natural step would be to manufacture a gluten free line of your current products. If we choose bread for example. Steps and processes to consider would include: Your supplier ability to supply gluten free ingredient and this includes packaging material. Packaging materials could contain gluten containing adhesives or slip agents. Cross contamination risk is to be mitigated at your facility and your suppliers. Chances are they are producing Gluten and non-gluten ingredients. Non-dedicated equipment change over and sanitation and cleaning in general. Employee training regarding the gluten free risks and their responsibilities. Testing of finished goods to validate that products are within the gluten containing threshold in the region to be sold. Typically <20ppm. All of these and more are to be considered elements of a gluten free control program

Gluten Free Certification Process Apply to the Programme Complete the Facilities Questionnaire ► Obtain GFCP Documentation Sign your Programme License Agreement (PLA) Confirm License Fees ► Define Products (SKUs) on Schedule “A” Conduct your GFCP Audit Stand Alone ► Combined with HACCP/GFSI ► Intertek Use the GFCP Trademark Confirm Trademark Approval Contract ► Approve Artwork Samples

    Summary Gluten occurs naturally in: Wheat (including: Durum, Einkorn, Emmer, Faro, Spelt), Barley, Rye and Triticale (a wheat : rye cross). Can be found in Oats Rice and Corn because of cross contamination by using the same processing equipment. Gluten-free” is defined as <20ppm Impacts the small percentage of the population with Celiac Disease and wheat allergy/sensitivity GFCP: Gluten Free Certification Programme administered by the ACG (Allergen Control Group) and endorsed by the CCA (Canadian Celiac Association) and NFCA (National Foundation for Celiac Awareness)   

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