Gluten-Free Labeling, Testing and Control Programs

Gluten-Free Labeling, Testing and Control Programs Gluten has dominated food headlines in recent years as gluten-related food sensitivities have become significantly more prevalent. Gluten is now a high priority consideration for more consumers shopping in retail food stores. As a result, food manufacturers have realized the complexity involved with adjusting their business models to respond to this reality. From product development, to operations, to marketing, new issues and considerations emerge that likely had not previously existed. WHAT IS GLUTEN? health. The only treatment for celiac disease, which affects about 1% of the population, is a strict gluten-free diet for life. Gluten is a collective term for the storage proteins found in wheat, barley, rye and their hybridized strains. It is the gluten in flour that helps bread and other baked goods bind and prevents crumbling. This feature has led to gluten being widely used in the production of many processed and packaged foods. Patients can present with a variety of intestinal and non-intestinal symptoms including anemia, chronic diarrhea, weight loss, fatigue, cramps, bloating and irritability. People with celiac disease vary greatly in their sensitivity to gluten, and although one may have no obvious symptoms, damage to the intestinal lining is still present. However, there is a spectrum of gluten-related disorders including wheat allergy, celiac disease, and non-celiac gluten sensitivity, which make these foods dangerous to consume for affected individuals. The term non-celiac gluten sensitivity (NCGS) is used to describe the clinical state of individuals who develop symptoms when they consume gluten-contaminating foods, and feel better on a gluten-free diet, but do not have celiac disease. The clinical symptoms of NCGS and celiac disease overlap making it difficult to distinguish the two disorders on the basis of symptoms alone. NCGS is frequently a self-diagnosis; hence the true prevalence is difficult to establish. There are currently no biomarkers for this disorder. A food allergy is an overreaction of the immune system to a specific food protein. Wheat allergy is sometimes confused with celiac disease, but these conditions differ. A wheat allergy can generate an allergy-causing antibody from any of the proteins found in wheat, whereas celiac disease is specific to only one component of wheat, gluten, which is also found in barley and rye. Over the last decade, an increasing number of people have decided to follow a gluten-free diet for perceived health benefits. This has renewed both interest and concern whether these individuals have a true glutenrelated disorder. Regardless, thanks to the increased promotion of heath and wellness and the increased diagnosis of celiac disease and other gluten disorders; Celiac disease is a multi-system autoimmune disorder, in which the absorptive surface of the small intestine in genetically susceptible individuals is damaged by gluten. The result is an inability of the body to absorb nutrients such as protein, fat, carbohydrates, vitamins and minerals, which are necessary for good 1

there has been substantial growth in the number of gluten-free products, making gluten free the fastest growing food intolerance category. Between 2007 and 2013 products with gluten-free claims gained market share, growing from 3.4% to 24.3% of new product launches in the U.S. and from 4.5% to 15.4% of total new product launches in Canada. Snacks were the most popular category of gluten-free food products introduced in both the U.S. and Canada in 2013. Top Categories of Gluten-Free Product Launches Categories U.S. Canada Total gluten-free food products Snacks Dairy Sauces & Seasoning Bakery Processed fish, meat and egg products Sugar and gum confectionary Desserts and ice cream Total gluten-free beverages Mintel Global New Products Database 2014 10,482 2,453 (23%) 1,327 (13%) 1,218 (12%) 1,107 (11%) 946 (9%) 590 (6%) 515 (5%) 1,645 2,344 570 (24%) 109 (5%) 273 (12%) 329 (14%) 244 (10%) 120 (5%) 127 (5%) 197 As a result of this growth, the global gluten-free market is projected to reach US$6.2 billion by 2018, with North America contributing about 59% of the share (Markets&Markets 2013). According to the Hartman Group s Health & Wellness 2015 report, in 2015, one in five consumers are avoiding gluten in their daily diet. PROPER ALLERGEN LABELING In 2004, the FDA introduced the Food Allergen Labeling and Consumer Protection Act (FALCPA). With it s implementation in 2006, this act mandated that food manufacturers identify major allergens in plain and common language, including clarifying technical names for ingredients (e.g. whey) by using common names (e.g. milk). FALCPA identifies eight foods or food groups as the major food allergens. They are milk, eggs, fish (e.g., bass, flounder, cod), Crustacean shellfish (e.g., crab, lobster, shrimp), tree nuts (e.g., almonds, walnuts, pecans), peanuts, wheat, and soybeans. There are a number of other foods that have been identified as having allergenic properties such as sesame and mustard, but FALCPA does not cover these. Though FALCPA applies to products regulated by the FDA, USDA (through FSIS) subsequently indicated it would follow FALCPA for products regulated under its jurisdiction. In addition, FALCPA applies to foodservice products, but not items packaged in a wrapper or box, as is typically seen in fast food establishments. FALCPA outlines two ways in which food products containing allergenic ingredients or proteins derived from allergenic ingredients should be labeled: Because of this, the availability of gluten-free products has expanded beyond health food markets into more traditional grocery stores. In 2013, 62% of gluten-free purchases were from supermarkets and mass merchandisers, 30% from health and natural food stores, and the remainder from club-type stores, drug stores and other retailers (Markets&Markets 2013). It is now common for retailers to have their own private label for gluten-free products. 1. Include the name of the food source in parenthesis following the common or usual name of the major food allergen in the list of ingredients in instances when the name of the food source of the major allergen does not appear elsewhere in the ingredient statement. 2. Place the word contains followed by the name of the food source from which the major food allergen is derived, immediately after or adjacent to the list of ingredients, in type size that is no smaller than the type size used for the list of ingredients. 2

The Clean Label Trend and Gluten-Free Labeling While the consumer demand for clean food labels has grown in recent years, the definition of what constitutes a clean label remains inconsistent. There is no definition of clean label published by the FDA or any other regulatory authority. The trend is generally defined by demand for short ingredient lists and simpler, more natural ingredients. In addition, consumers are increasingly attracted to brands they feel are trustworthy and offer transparency in regards to where and how products are manufactured. Another well-recognized aspect of the trend is its effect on product labeling and label claims. Consumers are drawn to claims that signify an absence of a specific substance or group of substances, including statements such as free from, contains no, and others. Gluten-free claims constitute a large portion of the free from or -free claims that exist. In 2007, the FDA proposed a final rule to mandate consistent labeling standards for the growing niche product category that was gluten-free foods. The rule was eventually finalized in 2013 and became effective on August 5, 2014. The rule states that the labeling claim, gluten-free means that the food bearing the claim in its labeling does not contain any one of the following: An ingredient that is a gluten-containing grain (e.g. spelt wheat); An ingredient that is derived from the gluten-containing grain and that has not been processed to remove gluten (e.g. wheat flour); An ingredient that is derived from a gluten-containing grain and that has been processed to remove the 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; or 20 ppm or more gluten in the food The FDA regulatory tolerance of less than 20 ppm for gluten-free labeling claims parallels the gluten-free labeling mandates established by Health Canada and the European Union. In Canada, a gluten-free claim is acceptable provided a food, prepared under good manufacturing practices, has less than 20 ppm gluten as a result of cross-contamination. The European Commission regulations (No 41/2009) established a 20 ppm gluten labeling threshold for finished food products. The European standards followed the development of the international standard for gluten-free labeling by Codex Alimentarius. More recently, the FDA has sought to clarify requirements for making gluten-free claims on fermented or hydrolyzed foods. On November 8, 2015, the administration published a proposed final rule that would amend the existing gluten-free final rule published in 2013, as that final rule identified uncertainty with the compliance methods established in the final rule for fermented, hydrolyzed, or distilled foods or ingredients. The proposed rule states that in cases whereby analytical methods are not available to verify compliance with the 20 ppm standard for gluten-free labeling, the rule would require companies to provide records to show compliance. Finalization of this rule is expected by Spring of 2017. Allergen & Gluten Related Recalls Since the implementation of FALCPA in 2006, allergens have persisted as a leading reason for recalls of food products regulated by FDA. Since 2011, there have been at least 150 recall events per year due to allergens in both the US and Canada. Recall situations range from many small-scale, low-impact events to a handful of larger events that have attracted attention on a global level, such as the contamination of ground cumin or cumin powder with peanut protein that occurred in the spring of 2015. In 2016, allergens surpassed microbial contamination as the leading reasons for FDA recalls for the first time, with foreign matter, processing errors, and mislabeling (non-allergen) rounding out the top five. Recall events related to the gluten-free labeling claim have become more prevalent in recent years as well. When a food label reads gluten-free, consumers that suffer from celiac disease, non-celiac gluten sensitivity, 3

or wheat allergy expect that the food will be safe to eat. Though FALCPA has outlined requirements for the gluten-free declaration, ensuring accurate labeling can be complex. Some common reasons for recalls of gluten-free products include wheat ingredients missing in the ingredient declaration, the common name wheat missing (e.g. only flour is declared), hidden allergenic ingredients (e.g. wheat from sugar syrup), and wheat from cross contamination. TESTING AND TECHNOLOGIES FOR ALLERGEN CONTROL PROGRAMS Analytical test results are only as good as the sample being tested and the reliability of the analytical test. Testing for the presence of gluten in a food or ingredient is complicated since the allergenic proteins or peptides can be located in hot spots in the original product. Including a hot spot in the collected sample is needed to detect its presence. Multiple samples should be collected at various locations and at different times during production (beginning/ middle/ end) to increase the ability to detect the allergen. Many industries use the same sampling protocols as published for allergens or for microbiological sampling. In addition, swabs are used to look for gluten present on surfaces, primarily to assess if a clean-out or a line-changeover was performed correctly. Several analytical methods are available to test for the presence of gluten by testing for the gliadin component. The most common analytical method is R5 Sandwich ELISA (EnzymeLinked Immunosorbent Assay) which tests for the gliadin composing ~50% of the gluten proteins. Gluten results are therefore 2X the level of the measured gliadin. A typical ELISA assay involves an antigen immobilized to the wells either directly via adsorption or via the antigen s primary antibody that has been bound to the plate. A sandwich assay occurs when the antigen to be measured is bound between two antibodies. After the antigen has been immobilized via a primary antibody bound to the plate, a second enzyme-linked antibody (primary or secondary) is added to form a complex. Detection occurs by either using a radioactive or fluorescent tag (in place of the enzyme) or adding a substrate that reacts with the enzyme. The FDA has currently identified two ELISA methods to utilize in the enforcement of the gluten-free labeling rule; the R-Biopharm s Gliadin R5 RIDASCREEN test kit (AOAC 2012.01), and the Morinaga Institute of Biological Science, Inc.: Wheat Protein ELISA Kit (Gliadin) which uses a unique extraction buffer for highly processed foods. These tests utilize the R5 monoclonal antibody which is specific to the detection of the gliadin protein. Another option is a lateral-flow device which detects if gluten is present above a defined threshold level (and may provide semi-quantitative results). Additional methods include Polymerase Chain Reaction (PCR) to detect the presence of DNA instead of the protein, and Adenosine Triphosphate (ATP) swabs used to evaluate surface cleanliness. Methods based on LC-MS/MS are being explored due to their ability to detect multiple allergens (and gluten) at lower detection limits. A challenge occurs when measuring gluten levels in hydrolyzed or fermented foods / ingredients where the gluten proteins may have broken down into smaller parts (peptides) that can be missed by sandwich ELISA. There are Competitive ELISA kits available that measure these peptides, but be sure the correct test is being used for your product! GLUTEN-FREE CERTIFICATION PROGRAM AUDITS The Gluten-Free Certification Program (GFCP) is a voluntary, science-based program designed for manufacturers and brand owners committed to producing safe, reliable, gluten-free products for consumers suffering from celiac disease and non-celiac gluten sensitivity. The program requires the implementation of stringent, risk-based and preventative gluten-free controls combined with a globally recognized food safety management system; in order to meet or exceed FDA, Health Canada and government requirements around the globe. A manufacturing facility and its gluten management system is certified following an annual third-party facility audit conducted by an approved ISO 17021 accredited certification body. 4

Once certified, a facility is permitted to self-declare their gluten-free claim using the GFCP trademarks endorsed by North America s leading celiac organizations, Beyond Celiac and the Canadian Celiac Association. Launched in 2011, the GFCP now reaches 25 countries, more than 200 certified facilities, and more than 5,000 products display the GFCP trademark. Certification bodies who audit facility management systems meeting the requirements of the GFCP are accredited by the ANSI-ASQ National Accreditation Board (ANAB) under ISO/IEC 17021-1, the international standard that specifies requirements to which management systems certification bodies must conform. The GFCP is the first and only ANAB accredited gluten management system. All other gluten certifications rely on end-product testing to provide a product certification as opposed to the increased risk assurances provided by a facility certification. All approved auditors who have a history of auditing food safety and quality management systems under a licensed GFCP auditing body, must have also completed GFCP Approved Auditor Training and achieved 80% or greater on the corresponding exam, and hold a certificate in good standing from one of the following food safety schemes: BRC Global Standards for Food Safety, FSSC 22000, IFS Food Standard or SQF 2000. The road to Gluten-Free Certification begins with applying to the program to gain access to the technical documents and signing a Program License Agreement and Schedule A to identify the manufacturing facility, brands and SKU s in question. It is then up to the facility s designated internal resource to become educated on the standards and manage the development and implementation of the management system. First steps may include; obtaining training; conducting a GAP Analysis; and appointing a cross functional team, made up of QA, Marketing and Regulatory, to support the process. At that point, you can conduct a hazard analysis identifying gluten as a chemical risk. It will also be necessary to identify control points, monitoring, verification and validation processes, and the necessary corrective actions to take when limits are exceeded or requirements are not met. Once a facility has developed and implemented its Gluten Management System, it is time to select a GFCP Approved Certification Body such as Mérieux NutriSciences to complete the certification audit. The GFCP audit can either be conducted in combination with a GFSI recognized scheme or as a standalone audit. At the time of the audit, the objective of the GFCP Approved Auditor is to confirm that the facility s Gluten-Free Management System is up-to-date, has been effectively reassessed, meets the requirements of the Gluten-Free Certification Program, is implemented as described, and is supported by Senior Management. This is accomplished by routinely reviewing documentation and records, observing procedures being implemented and interviewing/questioning a selection of employees. The audit scope includes verification of the Gluten-Free Management System performance, reporting process, the Gluten-Free Management System, the pre-requisite programs and the maintenance and reassessment procedures. The audit is in-depth and covers the production process, from carefully assessing ingredient suppliers through to packaging, with a focus on cross contamination potential. It will evaluate if the program is robust and implemented throughout the production process. Review of programs and records that support all control programs includes: Gluten Control/ Risk Assessment Traceability/ Recall Supplier Approval Raw Ingredient Verification Programs Labeling/ Packaging Change Management and Corrective Actions Production Controls Cross Contamination Controls Results of the audit are communicated to the facility through a report during the closing meeting and followed up with a formal written report as soon as possible. The audit report includes the scope of the audit, any Corrective Action Requests (CAR) and 5

Fresh Intelligence on gluten-free logo preference indicated 68% of respondents preferred the GFCP endorsed trademark over a similar non-endorsed Gluten-Free Logo (21%) and a generic gluten-free logo (11%). When asked what they liked about the logo, responses included: looks most official and gives the most amount of information; More eye-catching and carries Celiac Association endorsement; and attracts my attention better. overall comments on the result of the audit. Once the Certification Audit has been passed, a Certificate of Recognition is issued. At this point, products listed on Schedule A and manufactured in the facility are only then permitted to use the GFCP Trademark(s) on pack and in marketing. Associating a brand with exclusive endorsements from North America s leading consumer celiac organizations, Beyond Celiac and the Canadian Celiac Association, displayed on the GFCP Trademarks augments trust with the important consumer segment who depend on gluten-free products for their health. Independent research conducted by For more information visit For more information on the Gluten-Free Certification Program visit www.glutenfreecert.com 6