Making Food Safer Through Law and Technology

Although some concerns have been raised that certain people can experience adverse effects from levels lower than this, the Gluten Intolerance Group of North America and the Celiac Disease Foundation support the new definition. The FDA recommends individuals who are extremely sensitive to any amount of gluten should consult with their physicians to develop an appropriate diet plan.

One way for companies to ensure a product meets the new FDA standards for gluten-free is to certify it through the NSF Gluten-Free Certification Program. NSF International is an independent, global organization that certifies products for the food, water, health sciences, and consumer goods industries to minimize adverse health effects and protect the environment. The NSF Gluten-Free Certification Program verifies that certified products contain 20 ppm or less of gluten, in line with Codex Alimantarius Commission Standard, the European Commission Regulation Health Canada, and the FDA regulation. When certification is successfully completed, the product earns a NSF Gluten-Free label.

During an onsite NSF inspection for certification, a random sample is collected and tested using ELISA-based methods to establish gluten-free integrity at 10 ppm or less. (Testing for a significantly lower gluten threshold than certification requirement of 20 ppm or less takes into account the variability of ingredient lots and batches and ensures, as well as possible, the food being tested never exceeds the allowed ceiling of 20 ppm of gluten.) The inspector verifies that the manufacturing process prevents gluten contamination of products, and raw ingredients have been tested for gluten. The inspector also verifies the allergen affidavits and certificate of analysis, as well as confirms raw ingredients were sourced from QAI (Quality Assurance International) Gluten-Free suppliers.

According to Jaclyn Bowen, general manager of NSF International Agriculture and QAI, “A well-developed and well-executed gluten-management program goes hand in hand with other food safety management systems. Testing alone is not sufficient to ensure the gluten-free compliance of your product. An investment in a quality management system that evaluates supplier assurance, good manufacturing practices, and ongoing training is your best option to ensure your products reproducibly meet the requirements of the FDA Gluten-Free Final Rule.”

The publication of the gluten-free definition draws more focus on the overall presence of various allergens. The year 2013 saw an advance in allergen testing born from a collaboration between Romer Labs of Tulin, Austria, and ifp Institüt fur Produktqualität of Berlin, Germany, when they launched the AgraQuant F.A.S.T. (Fast, Accurate, Simple Technology) ELISA test kit to meet the increasing number of restrictive government regulations.

Romer Labs gathered feedback from the food industry to help guide the development of the benefits of AgraQuant F.A.S.T. According to the company, it is currently the fastest allergen testing kit on the market, with an extraction time of one minute and an assay performance time of 30 minutes. A 1 gram sample is required, although Romer Labs recommends taking multiple samples that are well-homogenized then subsampled to ensure it is representative of the product. Two capsules, using a proprietary technology developed by ifp, are then added to the sample, one filled with extraction buffer and one with additional extraction enhancement substances. After 20 milliliters of hot water (80 degrees to 100 degrees Celsius) are added, the sample is shaken for 15 seconds so the capsules dissolve and proteins from the sample are extracted. The sample is then filtered or centrifuged so it can be used for the ELISA assay.

In addition to its fast time to results, Elisabeth Halbmayr-Jech, technical manager with Romer Labs, points out, “AgraQuant F.A.S.T. allows the technician to use one extract over multiple test kits to look for several allergens. This feature adds to the speed of the process and reduces the chance for error. Also, the test kit requires very little training.”