Going Gluten-Free: What Manufacturers Should Know

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 Requirements

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.