Are Your Products Gluten-Free?

However, even the best supplier program in the world can be quickly undermined if the manufacturer doesn’t follow GMPs and cross-contaminates or comingles gluten-free ingredients with others. Gluten-free products, ingredients, and processes must be segregated. This includes separate ingredient storage, product warehousing, distribution, preparation, and processing as well as personnel, equipment, and smallwares dedicated only to gluten-free processing.

All employees, including supervisors, should receive training that covers ingredients and processing as well as compliance with internal label controls and verification procedures. Employees who handle, formulate, process, and package gluten free products must receive specific training on awareness and proper procedures.

Considerations for Retailers and Specifiers. Like manufacturers and suppliers, retailers and specifiers must also have confidence in their sources of gluten-free products. A structured and well-managed supplier qualification program and approval process is essential. Verification through supplier certification or internal verification testing is a good approach. Separation and hygiene rules also apply in-store, especially for products that are exposed in merchandising.

Third-Party Gluten-Free Certification

The final rule does not specifically require manufacturers to test for gluten in their ingredients or finished foods labeled gluten-free. However, manufacturers are responsible for ensuring that any gluten-free claim it makes is truthful and complies with FDA regulations. Quality control tools to accomplish this include conducting in-house gluten testing of ingredients and/or finished foods, employing a third-party laboratory to conduct gluten testing, requesting certificates of gluten analysis from ingredient suppliers, and participating in a third-party gluten-free certification program.

“Third-party gluten-free certification shows that companies have the right processes in place (including a quality management system, good manufacturing practices, supply chain assurance, and employee training) to prevent gluten contamination and to consistently stay below 20 ppm gluten,” says Jim Bail, director of food safety consulting at NSF International.

NSF International has seen a big increase in inquiries from companies about gluten-free certification since the FDA rule was announced. To earn certification under the NSF program, companies must have a gluten-free compliance plan and undergo onsite inspections of their production and handling facilities. Certification also requires ongoing compliance through annual manufacturing facility inspections and product testing.

NSF analyzes product labels for compliance, examines a company’s processes for shipping, receiving, storing, and handling raw ingredients and finished products, and verifies procedures for sanitation, quality control, testing, record retention, and product recalls.

During the onsite audit, an accredited inspector collects random product samples, verifies the company conducts appropriate raw ingredient testing or sources raw ingredients from a certified gluten-free supplier, and confirms that the manufacturer and its suppliers and handlers have procedures to prevent contamination and comingling.

NSF’s gluten-free certification program is ISO/IEC Guide 65 accredited and verifies that products contain 20 ppm or less of gluten in ISO/IEC 17025 accredited labs. NSF microbiologists test food samples using scientifically valid methods for replicable and reliable results. This includes a step-by-step, systemic approach and duplicate methods and controls for test validity.

Scientists use an analytical biochemistry assay with antibodies and a spectrometer to detect and quantify the presence of gluten. Specifically, NSF uses a sandwich-based enzyme-linked immunosorbent assay, or ELISA, kit from R-Biopharm, one of the same methods the FDA uses. The kit and recommended test procedures, which NSF follows, are performance tested by the AOAC Research Institute.

Global Food Safety Initiative (GFSI) standards (such as SQF and BRC) do not have specific requirements for gluten, but do require training, supply chain assurance, and GMPs. Companies with these procedures in place can combine GFSI and gluten-free audits, and companies already certified to a GFSI standard will likely already meet some of the requirements for gluten-free certification. Likewise, training, supply chain assurance, and GMPs are also core pillars of not only gluten-free compliance, but also of the Food Safety Modernization Act.

Gluten-Free Labeling Globally

Regulations for gluten-free labeling don’t stop at the U.S. border. Companies looking to export need to be aware of other regions’ requirements. In general, the 20 ppm requirement of the FDA rule is consistent with international standards, including Codex Alimentarius Commission’s revised Codex Standard for Foods for Special Dietary Use for Persons Intolerant to Gluten, European Commission Regulation No 41/2009 that concerns the composition and labeling of foodstuffs suitable for people intolerant to gluten, and Health Canada’s Food and Drug Regulations.