Additional Processing Parameters to Protect Your Customers From Gluten

A Google search of the word combination “gluten free” returns a staggering 7 million results. Many provide information regarding gluten-free ingredients, recipes, and prepared foods currently available in the marketplace. This tidal wave of information is the result of the heightened interest in gluten-free diets of an increasing number of people who have been diagnosed with celiac disease (CD).

People affected by CD, a genetic disorder, are predisposed to an autoimmune response that causes damage to the small intestine when they eat foods containing gluten protein. This damage, in turn, causes the small intestine to lose its ability to absorb the nutrients found in food, leading to malnutrition and a variety of other complications. The disease is diagnosed in Australia, Europe, and the United States. The increasing regularity of this diagnosis has forced food manufacturers and regulatory bodies to develop additional processing parameters and methods of educating consumers. The Food and Drug Administration (FDA) recently proposed a gluten-free labeling rule for voluntary use in foods.1

The term gluten-free is actually deceiving: Not all gluten-containing ingredients cause detrimental effects for those with CD. According to the FDA, grains of wheat (including durum wheat, spelt wheat, and kamut), rye, barley, or triticale (a cross between wheat and rye) are prohibited. The effects of oats are undetermined. Complicating matters are similar peptide molecules found in amaranth, buckwheat, corn, Indian ricegrass, Job’s tears, millet, quinoa, ragi, rice, sorghum, teff, and wild rice, all of which are generally well tolerated by those with CD.

Manufacturers who process wheat or other gluten-containing products increase the risk of falling short of regulatory technical needs. Fortunately, systems such as segregation and proper sanitation can ensure that requirements are met. Given the cost of implementing such systems, however, it is understandable that manufacturers might need to charge a premium to maintain a gluten-free status.

Manufacturing Criteria

Gluten-free diets help to minimize CD, but stringent proposed rules for food manufacturers are problematic. Many requirements need further clarification. Over time, strict avoidance of diets containing gluten can resolve symptoms, reduce associated health risks, and possibly even reverse the damage caused by CD.2

This information leads to conjecture that CD may not be caused by an acute reaction to products containing gluten. Studies have shown that while uncontrolled diets containing gluten trigger harmful effects, ingestion of up to 10 grams of gluten (5 grams of gliadin) a day for several weeks is required for adult gluten challenge studies.3 In other words, adequate quantities over a prolonged period are required to provoke a CD response. If this is true, why do manufacturers need to maintain strict parts per million (PPM) levels in order to achieve gluten-free status? The current standard for claiming gluten-free status is no more than 20 PPM. This stringent standard makes sense in the case of allergens, in which even low PPM levels might cause anaphylactic shock.

Companies can achieve gluten-free status by following certain internal procedures. As industry and regulatory bodies finalize standards, additional external criteria will likely evolve. Methods that manufacturers may use to ensure gluten-free products include dedicated lines or even—depending on the volume of gluten-free products they manufacture—fully gluten-free plants.

Manufacturing facilities could be classified into one of the following categories. A facility processing only gluten-free products could be rated “low risk.” A facility with segregated lines—or proper sanitation controls and validations—with proper processing controls could be rated “medium risk.” A facility with many different allergens, fewer controls, and improper documentation could be given a “high risk” rating.

Manufacturers of gluten-free products in facilities that are not 100% gluten free must have segregated areas for receiving raw ingredients from suppliers. These areas must be placarded and kept free of prohibited substances. Plastic sleeves on pallets and color coding may help plant personnel avoid errors in pulling product or lot tracking for identification. Prior to processing lot numbers, product types and quantities pulled must be documented and verified by a supervisor. This step prevents accidental addition or contamination.