The committee also agreed with celiac patient organizations, including Celiac Canada, that labels should not create confusion by combining a “gluten-free” claim with a precautionary statement for cereals containing gluten when that precautionary statement is necessary. This gap has created significant confusion for consumers and their families. Although a product may meet the requirement of 20 ppm gluten or less for a gluten-free claim, a “May Contain Wheat” statement may have been intended to alert people with a wheat allergy to potential cross-contact. Celiac Canada’s labelling studies have identified these labels as confusing and unhelpful.

Why “May Contain” matters

Precautionary allergen labels — statements such as “May Contain Wheat” — are currently voluntary in many countries, including Canada. They are intended to warn consumers about the possible unintended presence of allergens or gluten due to cross-contact during manufacturing.

Over time, however, these warnings have become inconsistent and overused. There has been no clear standard to guide manufacturers on when the warning should be applied.

What next?

Once the Codex Alimentarius Commission considers the recommendations, it will be up to member countries, including Canada, to determine how they may implement the guidance in their own national systems.

Celiac Canada has already begun engaging with Health Canada on how these new international standards could be brought into force in Canada, including through policy, guidance, regulation or incorporation by reference. There would likely be a grace period for companies to come into compliance as they update labels and implement the required risk-based assessments.

The role of Celiac Canada

Celiac Canada has been a national champion in these discussions, working alongside Health Canada, international scientific experts and global patient organizations for the past several years. In addition to advocating for changes for decades since allergen and gluten labels entered the market in the mid-2000s, we participated in the recent CCFL49 meeting in Ottawa, made formal written submissions in response to Codex stakeholder consultations and provided consumer survey and research data to support the review.

By working collaboratively with groups including the Celiac Disease Foundation, Coeliac UK, the Association of European Coeliac Societies and other international partners, Celiac Canada has helped ensure that the lived experience of people with celiac disease remains part of the conversation.

This work builds on decades of advocacy that helped strengthen Canadian gluten and allergen labelling regulations in the first place. Canada has long been recognized internationally as a leader in gluten and allergen declaration requirements.

A historic shift at the global level

The challenge for international experts was that reference doses had been established for a wide range of IgE-mediated food allergens, including wheat, but had not fully accounted for the distinct realities of celiac disease. For people with celiac disease, the concern is gluten exposure from wheat, barley and rye, not only wheat as an allergen.

A team of scientific experts, including experts connected to the International Society for the Study of Celiac Disease and led by Dr. Jason Tye-Din of Australia, was asked to consider a reference dose for gluten that could be used in the precautionary allergen labelling framework.

The recommendation was that a reference dose of 4 mg gluten could be used by manufacturers and regulators — not as consumer advice and not as a new gluten-free threshold — but as part of a risk-based assessment of the unintended presence of gluten in mainstream food products.

The standard for foods labelled “gluten-free” is not changing. Foods labelled gluten-free remain subject to the existing standard of no more than 20 parts per million gluten.

The 4 mg gluten reference dose serves a different purpose. It is used to help calculate an action level for a food product. That action level depends on how much of the food someone would reasonably be expected to consume in a single eating occasion.

In simple terms:  Action level = reference dose / amount of food consumed

This means the 4 mg reference dose is an amount of gluten, while the action level is the food-specific concentration that can be calculated using that amount and the expected amount of food consumed.

If the Codex guidance is adopted and then implemented by national authorities, food businesses would be expected to conduct a risk-based assessment to determine whether unintended gluten presence from cross-contact can be prevented or reduced to the relevant action level. A “May Contain” statement would be used when that unintended presence cannot be reduced to the action level. If the unintended presence is at or below the action level, the precautionary statement should not be used.

And for the first time in history, celiac disease and gluten were formally and meaningfully integrated into these global discussions alongside food allergens. That matters enormously.

Historically, precautionary allergen labelling frameworks were largely designed around IgE-mediated food allergies. But celiac disease is different: it is an autoimmune disease triggered by gluten exposure, even at very small levels.

Recognizing gluten and celiac disease within international precautionary allergen labelling guidance acknowledges what the celiac community has long known: people with celiac disease deserve clear, evidence-based protections too.

For more background on precautionary allergen labelling and gluten, read our earlier article: How Do We Solve a Problem Like “May Contain”?