Defining "Gluten-Free"

“Gluten-free” on the label has many meanings. Do not assume gluten-free means the complete absence of gluten.

There is no United States standard for use of the term “gluten-free” on labels or products. A proposed definition for voluntary use of "gluten-free" was posted in the Federal Register on January 3, 2007 by the United States Food and Drug Administration (FDA). 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  the "gluten-free" definition in July of 2008. The Codex definition is now the standard for gluten content allowed in a food product to be considered gluten-free for international trade in countries that sign on.

The FDA proposal and Codex definitions for “gluten-free” requirements are remarkably similar.

Seeking a Meaningful, Verifyable and Consistant Definition

Regulations will allow a wide range of gluten in a product labeled "gluten-free". Within this range will be products fine for one person that evoke symptoms for others. CSA members asked for a simple symbol to identify the most risk free products.  In 2004 CSA began a program to recognize those "gluten-free" products suitable for those with celiac disease that meet the most risk free criteria. The sucessful program was based upon results of member surveys.  Products bearing the CSA  Recognition Seal are suitable for all those on a celiac diet -- sensitive or not so.  To assure risk-free choices for all celiacs, products are free of wheat, barley, rye, oats, their crosses and derivatives in product ingredients, processing and packaging. Fees for this communication tool are kept to a minimum.

The following chart compares requirements for the Codex Alimentarius, FDA, and the CSA Recognition Seal definitions.
 
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)
     
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 20 mg/kg (20 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 in products with the Seal. 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 predict which celiacs may have such a response.
     
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
     
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 commercial methodology the extent or consistency of the processes is not measurable.  
     
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.

Any product may bear the CSA Recognition Seal by meeting 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”
     
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
     
Requirement #7—Manner of analysis/sampling and determination of gluten content

Codex revised definition

FDA proposed definition

CSA-Recognition Seal definition
ELISA ELISA Cross reactive ELISA to verify ingredient review and sourcing and that facility procedures control cross or outside contamination (HACCP)
     
Requirement #8—Upper limit of gluten content

Codex revised definition

FDA proposed definition

CSA-Recognition Seal definition
20 ppm (20 mg/kg) in food as sold or distributed to consumer 20 ppm Absence of WBRO—with verification test below level of quantification at 5ppm