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DEFINING THE TERM “GLUTEN-FREE”
When reading food and other product labels, it is important to note that the label “gluten-free” can mean a variety of things. Gluten-free does not ALWAYS mean the complete absence of wheat, barley, rye and oats (WBRO) in the product.
Presently, there remains no national standard in the United States for the term “gluten-free”. The United States Food and Drug Administration (FDA) has proposed a definition for voluntary use of the term which was posted in the Federal Register on January 3, 2007. The entire document is available at http://www.cfsan.fda.gov/~lrd/fr07013.html. The final form of the definition was expected to be published in August, 2008. To date, it remains in draft form.
On the other hand, the Codex Alimentarius Commission (a joint effort of the Food and Agriculture Organization of the United Nations [FAO-UN] and the World Health Organization [WHO]) revised its Standard for Foods for Special Dietary Use for Persons Intolerant to Gluten at its July 2008 meeting. The Codex definition is now the standard for gluten content allowed in a food product to be considered gluten-free for international trade.
The FDA and Codex definitions for “gluten-free” are remarkably similar in their requirements.
CSA has chosen to use a more stringent definition for “gluten-free” for purposes of the CSA Recognition Seal. To assure that products bearing the CSA Recognition Seal are risk-free choices for all celiacs, products must be completely free of wheat, barley, rye, oats, their crosses and derivatives in product, processing and packaging.
The following chart compares requirements for the Codex Alimentarius, FDA, and the CSA Recognition Seal definitions.
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Requirement #1—Gluten-free foods cannot contain any of the following:
Codex revised definition |
FDA proposed definition |
CSA-Recognition Seal definition |
Wheat (all species), barley, rye, oats, all crossbred varieties (WBRO) |
Wheat (all species), barley, rye, all crossbred varieties (WBR) |
Wheat (all species) barley, rye, oats, all crossbred varieties and derivatives (WBRO) |
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Requirement #2—Use of oats in gluten-free foods
Codex revised definition |
FDA proposed definition |
CSA-Recognition Seal definition |
Allowance left to national definitions but if allowed, oats cannot be cross contaminated and must test at less than 0mg/kg (0 ppm) for cross contamination with wheat, barley or rye. |
Allowed, but oats must not be cross contaminated and must test at less than 20 ppm (parts per million) for cross contamination with wheat, barley, or rye. |
Not allowed. Oats are not a risk-free choice for all celiacs. In vivo and in vitro studies indicate that some celiacs have an immune response even to pure, uncontaminated oats. Presently there are no indicators available to determine which celiacs may have such a response. |
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Requirement#3—Ingredients from WBRO grains that have not been processed to remove gluten (e.g.: hydrolyzed wheat protein, farina, barley malt and extract, malt vinegar)
Codex revised definition |
FDA proposed definition |
CSA-Recognition Seal definition |
Not specifically addressed in definition |
Not allowed |
Not allowed—Source ingredients and additives cannot be from WBRO grains |
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Requirement #4—Ingredients “specially processed to remove gluten”—(e.g. food starch, wheat starch, distilled alcohols and vinegars from WBRO grain sources)
Codex revised definition |
FDA proposed definition |
CSA-Recognition Seal definition |
Allowed; gluten content not to exceed 20 ppm in the food as sold or distributed to the consumer |
Allowed: gluten content not to exceed 20 ppm in the food |
Not allowed—with present available methodology, it is difficult to determine the extent or consistency of the purity of such products |
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Requirement #5—Inherently or naturally gluten-free foods (e.g. milk, fruit, vegetables, single ingredient foods, non “gluten containing” grains such as corn, rice, millet)
Codex revised definition |
FDA proposed definition |
CSA-Recognition Seal definition |
Must be less than 20 ppm
May not be labeled “special dietary” or “special dietetic” but may state “this food is by its nature gluten-free” |
Must be less than 20 ppm
Is deemed misbranded unless the labeling clearly indicates that all foods of the same type, not just the brand bearing this labeling claim are gluten-free (e.g., “milk, a gluten-free food,” “all milk is gluten-free”) |
Must be unquantifiable at 5 ppm.
Such products may bear the CSA Recognition Seal as long as they meet the criterion of less than 5 ppm—indicative of the absence of cross or outside contamination. Use of the Seal infers the absence of WBRO source ingredients and does not use the term “gluten-free” |
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Requirement#6—Low gluten foods with gluten content between 20 and 100 ppm.
Codex revised definition |
FDA proposed definition |
CSA-Recognition Seal definition |
Allowance to be determined at the national level. Cannot be labeled as gluten-free; wording of claim to be determined at national level |
Not allowed in labeling—because of insufficient scientific data to recommend a specified level of gluten to define the term “low gluten” |
Not allowed in labeling. The Recognition Seal identifies risk-free choices only |
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Requirement#7—Manner of analysis/sampling and determination of gluten content
Codex revised definition |
FDA proposed definition |
CSA-Recognition Seal definition |
ELISA |
ELISA |
ELISA to verify ingredient review and sourcing, facility procedures to control cross or outside contamination |
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Requirement #8—Upper limit of gluten content
Codex revised definition |
FDA proposed definition |
CSA-Recognition Seal definition |
0 ppm (0mg/kg) in food as sold or distributed to consumer |
20 ppm |
Absence of WBRO—with verification test below level of quantification at 5ppm |
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