Compliance and enforcement of gluten-free claims

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).

Health Canada's current position on gluten-free claims will be used to guide the CFIA's compliance activities and enforcement actions.

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.

Manufacturers and importers of gluten-free foods are expected to make every reasonable effort to minimize gluten present through cross-contamination. In instances where the gluten is present due to cross-contamination at a level of less than 20 ppm in the food, 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 include a recall of the product, nor a request to remove the gluten-free claim.

In all instances, regardless of source, if more than 20 ppm of gluten is present in a food labelled as gluten-free, the product may 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, subject to appropriate enforcement action by the CFIA, which may include the possibility of recall.

All information appearing on the labels or in advertising, including trademarks, brand names, pictures, logos, or slogans that suggest or imply a food is gluten-free will be assessed against the above criteria and may be subject to appropriate enforcement action by the CFIA if determined to contravene the FDA and/or the FDR.

Intentional addition

As described in Health Canada's position, foods containing gluten as a result of intentional addition may not be represented as being gluten-free. However, if a manufacturer using a cereal-derived ingredient includes additional processing steps which are demonstrated to be effective in removing gluten, the food may be represented as gluten-free.