The market for gluten-free products has grown from essentially unmeasurable to a multi-billion-dollar industry over the last 20 years. Estimates of the value of the global gluten-free market range from a projected $4.7 to $7.9 billion in 2020, up from $1.7 billion in 2011, according to Financial Times.
Explore this issueDecember/January 2018
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Gluten is a collective name for proteins found in wheat, rye, barley, and triticale as well as derivatives of these grains, such as barley malt and wheat germ. These proteins are present in a wide variety of ingredients commonly used in food production, and play a vital role in a food product’s volume, texture, and appearance. Gluten can easily hide in foods such as malted milkshakes, herbal teas, artificial flavors, candy, bouillon cubes, and lunch meats.
Some individuals have a severe intolerance to consuming gluten called celiac disease, a hereditary autoimmune disorder. When they eat gluten, damage to the small intestine occurs and they can’t properly absorb nutrients into the body—resulting in nutritional deficiencies. Other symptoms might include chronic fatigue, osteoporosis, anemia, and reproductive health issues, says Alice Bast, CEO, Beyond Celiac, Ambler, Pa., a non-profit organization dedicated to raising awareness of celiac disease. If undiagnosed or untreated, celiac disease can lead to further complications such as the onset of other autoimmune diseases and some cancers. Go.BeyondCeliac.org says approximately 1 percent of Americans have this condition; diagnosis rates continue to rise as awareness of the disease grows.
“Individuals with celiac disease can only tolerate small trace amounts of gluten, so any presence must be low enough to be undetectable by scientific methods,” points out Genelle Chetcuti, senior director of marketing, RW Garcia, San Jose, Calif., which manufactures gluten-free snacks.
A 100 percent gluten-free diet is the only existing treatment for celiac disease, says Sue Newell, education manager, Canadian Celiac Association, Mississauga, Ontario. Drug treatments undergoing testing by the U.S. FDA are designed to supplement a gluten-free diet, not replace it.
Up to 6 percent of Americans, or 18 million people, exhibit similar symptoms to those with celiac disease when consuming gluten, according to Go.BeyondCeliac.org.
This is called a non-celiac gluten sensitivity.
Having to eat gluten-free in order to stay healthy is quite burdensome. Gluten-free consumers have to become expert label readers and be on the lookout for gluten hidden in food and beverage products. “While wheat is one of the top eight allergens that are required by law to be called out on food labels, rye and barley ingredients are not, putting the responsibility on consumers to recognize sources of gluten that may be hiding in the ingredients list,” Bast says. It’s also difficult for people with celiac disease or gluten sensitivity to dine out, due to potential cross contact in commercial kitchens.
Perceived Health Benefits
Some consumers who haven’t been diagnosed with a gluten sensitivity or intolerance are attracted to a gluten-free diet. They may perceive it as healthier or as a way to lose weight. “But this is not necessarily true,” Bast says. “While many naturally gluten-free foods are very nutrient dense (e.g., legumes, green leafy vegetables, dairy, and lean proteins), many packaged gluten-free products are not. Manufacturers should focus on product development not only for tasty gluten-free foods, but also for ones that are healthy.”
A nutritional comparison shows that gluten-free products are generally higher in calories, fat, and sugar and are lower in fiber, iron, and B vitamins than their regular counterparts, Newell notes. Gluten-free flour and baked goods are generally not fortified to the level of their wheat-flour equivalents.
But it is not surprising that someone might feel better when they first go gluten-free, however. “They will generally decrease the amount of highly processed foods and the number of restaurant meals they consume,” Newell says. “But this benefit is not necessarily related to gluten.”
Recent research indicates that eating gluten-free may increase the risk of heart disease and type 2 diabetes, perhaps because of a reduction in whole grain consumption, adds Newell. Gluten-free consumers are also at risk for higher levels of arsenic and mercury, depending upon the amount and source of the rice they consume to replace gluten grains.
Gluten-free labeling is voluntary. However, in order to be considered a “gluten-free” product in the U.S. and Canada, products must have a gluten content of less than 20 parts per million (ppm), which is equivalent to 20 mg of gluten per kg of product, says Kristopher Middleton, technical manager, Eurofins Food Safety Systems, a Des Moines, Iowa, company focused on food safety. The FDA has included the requirements for “gluten-free” labeling as part of the Food Allergen Labeling and Consumer Protection Act of 2004. The FDA published a final rule, which became effective Sept. 4, 2013, and outlined the requirements in place for gluten-free products under its jurisdiction. The USDA also requires gluten to be less than 20 ppm in products labeled gluten-free. Health Canada, Canada’s only food regulatory body, also requires products to contain less than 20 ppm of gluten in order to be labeled as “gluten-free,” “no gluten,” “free of gluten,” or “without gluten.”
In addition to the 20-ppm rule, Zeb Blanton, global food technical manager, SGS, a food inspection, verification, testing, and certification company in Rutherford, N.J., says manufacturers may label a food “gluten-free” if the food does not contain any of the following:
- An ingredient that is any type of wheat, rye, barley, or crossbreed of these grains;
- An ingredient derived from these grains that has not been processed to remove gluten; and
- An ingredient derived from these grains that has been processed to remove the gluten proteins, if it results in the food containing 20 or more ppm gluten.
Like the U.S., Canada has set a 20-ppm threshold in order to label a product gluten-free, says Laura Allred, regulatory and standards manager of Auburn, Wash.-based Gluten Intolerance Group (GIG), which certifies gluten-free products and food services.
The Assessment Process
The process of becoming certified as gluten-free is extensive. The first step of the process is to complete an application for all products and facilities that will be inspected and considered for certification from the organization they are seeking certification from, Chetcuti says. An auditor will conduct an inspection of the facility where the product is manufactured, or hold a consultation. Additionally, annual inspections of every facility are required, as well as regular testing of products and facilities. Inspectors may also make unannounced visits to a company’s facility, or collect products from grocery store shelves for testing. Overall, the process averages six to 18 weeks to complete. Here’s an overview of four certification organizations and what they offer.
Gluten-Free Certification Organization (GFCO). Developed by the GIG, this gluten-free certification program asserts that finished products and their ingredients contain 10 ppm or less of gluten. To gain certification, the product must also exclude any barley-based ingredients, Blanton says.
GFCO requires ongoing testing of products and equipment, and an annual audit. Manufacturers must also comply with all government regulations regarding allergens, gluten-free labeling, and Good Manufacturing Practices (GMP).
Allred points out that GFCO offers true accredited product certification as defined by the International Organization for Standardization (ISO) 17065 Standard. Certifications offered by organizations other than GFCO are referred to as “self-certifications,” in which a manufacturer decides if it has produced the gluten-free product safely. Some other certifiers require that the independent companies performing their certifications be accredited to a different ISO standard, 17021, which allows them to certify a company’s management system, but not the products themselves.
Gluten-Free Certification Program (GFCP). Administered by the Allergen Control Group and endorsed by North American Society for the Study of Celiac Disease, the GFCP employs a Hazard Analysis Critical Control Point (HACCP)-based standard that addresses incoming and process hazards, including undeclared gluten, as part of a manufacturer’s overall food safety management system, Blanton says.
The ingredients used in GFCP-certified products must contain 20 ppm or less of gluten, and the facility must have an auditable GMP/HACCP-based food safety system or equivalent in place. It must also undergo an annual audit from a GFCP-licensed auditing company or certification body.
Middleton says Eurofins Food Safety Systems chose to partner with the Allergen Control Group by using their GFCP because of its strict requirements to ensure that products are gluten-free. Another benefit is that it can be easily paired with a Global Food Safety Initiative certification audit, which is in high demand by many in the industry.
SGS Solutions: Independent Gluten-Free Certification. SGS is the only independent certification body offering manufacturers a choice of gluten-free certification schemes, Blanton says. With its global network of laboratories and specialists, it has the expertise to help manufacturers adopt effective gluten-free risk management policies.
Crossed Grain Symbol Gluten-Free Product Certification. Administered by the Association of European Coeliac Societies (AOECS), this scheme certifies that a product has 20 ppm or less of gluten. It involves a stand-alone audit against AOECS’ gluten-free standard, Blanton says. Manufacturing facilities producing AOECS-certified products must be audited, with finished products being tested annually by accredited laboratories.
Oats: A Controversial Grain
Although oats are biologically gluten-free because they aren’t a type of wheat, barley, or rye, commercial oats universally contain wheat and barley, starting with contaminated planting seed to shared processing equipment.
“Most consumers with celiac disease tolerate oats grown under a purity protocol well,” Newell says. “Attempts to clean the wheat and barley contamination using mechanical and optical processes are controversial because contamination occurs in hotspots throughout batches. One bite might be safe, the next might cause illness.”
Countries have different requirements regarding oats. In the U.S., oats fall in the category of non-gluten grains; they can be called gluten-free if they contain less than 20 ppm gluten.
Canada does not allow the use of regular oats in gluten-free products, Newell says, but GMP may bring the cross-contamination level below 20 ppm, meeting the requirements to use the label “gluten-free oats.”
The Codex Alimentarius standard states that gluten-free products must not contain oats and must not exceed 20 ppm. “The Codex definition includes oats as a source of gluten, but most countries have decided that oats that are free of contamination from wheat, rye, or barley can be considered gluten free,” Allred says.
Understanding and complying with an organization’s standards is probably the most challenging requirement for manufacturers. “Most companies fail to completely read, analyze, and implement a standard’s requirements and how it will be perceived by the auditor when they visit their facility to conduct the audit,” Blanton says. “It is important to fully review a company’s standard operating procedures, employee practices, written policies, food safety manuals, and so forth to ensure they meet a standard’s provisions.”
Think of the standard as a guide to compliance and how you would present evidence to the auditor to ensure they see that policies and procedures meet that goal. A good example is most standards require manufacturers to have an organizational chart showing who is responsible for each phase within the organization. “The auditor is not going to be able to assess a facility’s reporting lines unless he can see a clear chart showing the areas of responsibilities and their reporting lines for each position starting at the top,” Blanton says.
Allred recognizes that the diligence of the certification process requires a number of steps and documentation, and having a good grasp of all of the steps and requirements for certification is probably one of the most challenging aspects for clients. “We encourage them to stay in close contact with their customer service representative, who can let them know where they are in the process and what will occur next,” she says.