Gluten-Free Regulations

The requirements of the Gluten-Free Certification Program (GFCP) rely not only on HACCP and GMP’s to prevent failure of gluten management, but also the requirements and limits set in the regulations made by the national authority of the country in which the product is sold. Each jurisdiction mandates the level of protection for consumer safety within their respective sovereign nation. The GFCP clearly places the burden on industry to ensure that they understand and enforce these regulations into their current food safety management systems.

FDAUSA Regulations

On August 2, 2013, the U.S. Food and Drug Administration (FDA) announced a standard definition for “gluten-free” labeling of foods, which will be enforced starting August 5, 2014.

The FDA defines the term “gluten-free” and “gluten” for voluntary food labeling and standardizes the meaning of “gluten-free” claims across the food industry. The term “gluten” refers to proteins that occur naturally in wheat, rye, barley and cross-bred hybrids of these grains. The USFDA requires facilities and distributors recognize that the levels in gluten-free foods must be managed to use the term “gluten-free” on labels and to meet the definition, including that the food must contain less than 20 parts per million of gluten. The rule also requires foods with the claims “no gluten,” “free of gluten,” and “without gluten” to meet the definition for “gluten-free.” There is provision to add specially processed gluten-sourced ingredients if they have been rendered to be themselves as well as the finished product to be <20 ppm using the appropriate laboratory tests.

Health Canada

Canadian Regulations

A gluten-free claim is any representation in labelling or advertising that states, suggests or implies that a food is gluten-free, as per B.24.018 of the Food and Drug Regulations (FDR) which are administered by Health Canada. (Health Canada’s current position on gluten-free claims.)

The Canadian Food Inspection Agency’s (CFIA) compliance activities and enforcement actions will follow this guidance from Health Canada whereby any gluten that is present due to cross-contamination in a food labelled gluten-free should be as low as reasonably achievable and must not surpass 20 ppm of gluten, a level that is considered protective for the majority of people with celiac disease. (Canadian Food Inspection Agency (CFIA) Compliance and Enforcement of Gluten-Free Claims)

Manufacturers and importers of gluten-free foods are expected to make every reasonable effort to minimize gluten’s presence through cross-contamination. In instances where gluten is present due to cross-contamination at a level of less than 20 ppm, the CFIA will follow up with the manufacturer or importer regarding the presence of gluten in the product. These manufacturers and importers should have good manufacturing/importing practices (GMP/GIP) in place to achieve the lowest levels of gluten possible to avoid cross-contamination. However, based on Health Canada’s position, enforcement action on products containing less than 20 ppm gluten as a result of cross-contamination, will not trigger a recall of the product, nor a request to remove the gluten-free claim.

If more than 20 ppm of gluten are present in a food labelled as gluten-free, the product will be in violation of the FDR Section B.24.018 and/or Section 5.1 of the Food and Drugs Act (FDA) and, on the basis of a health risk assessment provided by Health Canada and subject to appropriate enforcement action by the CFIA, which will include the possibility of recall.

The GFCP parallels the CFIA’s guidance and for precautionary purposes will use the threshold of <20 ppm for gluten required by Health Canada and the CFIA.

If you require further clarification on the information above contact the GFCP or your local CFIA office.

The above applies to gluten-free products under USFDA only. The GFCP requires a similar approach to those under the USDA and the Alcohol, Tobacco Tax and Trade Bureau (TTB). However, definitive statements on their gluten-free rules and policies are not as available as USFDA’s. Therefore manufacturers and distributors are encouraged to contact the USDA or TTB.
For more information:

If you require further clarification on the information above contact the GFCP or your USFDA, USDA or TTB office.