CCA comments on gluten-free labeling regulation

The CCA submitted its response to Health Canada in July.  It’s important that members know what was said on this important issue.

Below is the email sent from Jim McCarthy to Health Canada and the full CCA submission.


We would like to commend Health Canada for this undertaking.  It is tremendously important to the members of our organization, the thousands of others dependent on the availability of gluten-free food, and the supply sector providing food and food services to them
Health Canada can count on the continuing active support and involvement of the CCA in this endeavour, and we urge Health Canada to proceed with haste to a resolution.



Thank you for initiating this consultation and requesting comments on Health Canada’s proposed policy intent for revising the ‘gluten-free’ labelling regulations.

From the results of the Canadian Celiac Association (CCA) survey, Living with a Gluten-Free Diet, done in collaboration with Health Canada and the Fondation québécoise de la maladie coeliaque, it is clear that Canadians with celiac disease want clear and easy to understand food labelling that informs them in an unambiguous manner that a food product is safe for consumption. In addition the gluten-free labelling regulation must reflect on evidence-based science on safe levels of gluten for individuals with celiac disease.

The CCA, with valuable input from its Professional Advisory Board and feedback from the membership, is providing the following commentary on the policy intent. We will look forward to active engagement and involvement in the process of redefining the GF labelling regulations, and urge Health Canada to proceed quickly in an inclusive manner with the revision process.

Several key points serve as the basis for CCA’s views. The regulation must:

Minimize the risk of inadvertent gluten consumption by those with celiac disease and maximize selection of safe gluten-free foods suitable for inclusion in a gluten-free diet.

Harmonize to the fullest extent possible with internationally accepted gluten-free standards and the regulations of key trading partners to protect consumers, reduce confusion among consumers and manufacturers about the gluten content of foods, minimize trade barriers, and reduce costs of gluten-free foods.

Establish a threshold that gluten free means <20ppm of gluten in any product, based on the current scientific evidence supporting the safety of less than 20 parts per million (<20 ppm or <20 mg/kg) of gluten as a safe level for gluten-free products. Health Canada has established a precedent for thresholds in regulation by indicating a specific level for the declaration of sulphites in ppm in Schedule 1220 Enhanced Labelling for Food Allergens and Gluten Sources and Added Sulphites.

CCA Comments on the Policy Intent for Gluten-free labelling

1. Consumers following a gluten-free diet for medical reasons must not consume the protein fraction of certain cereal grains (wheat, including spelt and kamut, – barley, rye or triticale) as defined by less than 20 parts per million (<20 ppm or <20 mg/kg) gluten. The CCA agrees that this level is safe for gluten-free products.

2. Several governments throughout the world have chosen < 20 parts per million (20 ppm or 20 mg/kg) as the standard for labelling a product gluten free. The decisions of food regulatory agencies are based on recent scientific studies. The CCA also recognizes that Codex has revised (2008) Codex Standard 118 – 1979 – ‘Codex Standard for Foods for Special Dietary Use for Persons Intolerant to Gluten’ and establishes this threshold level. This international standard is being used by some trading partners to establish the definition and threshold for ‘gluten-free’.
We suggest that Health Canada adopt the level of < 20 ppm as being safe for ingredients used in gluten-free products and for the final gluten-free products. The CCA understands concerns regarding threshold-based regulation, and recommends that Health Canada consider the actual level <20 ppm gluten be included as a standard or appendix that applies to the gluten-free regulation. This can be revised if the scientific knowledge about safe amounts of gluten changes in the future. We do not anticipate this knowledge to change in the near future.

3. Oats should be removed from the list of cereal grains currently in Food and Drug Regulation B.24.018. Further, ‘pure and uncontaminated oats’ as a cereal or flour may be labeled gluten-free as long as they test <20ppm of gluten. Products that contain ‘pure and uncontaminated oats’ may be labeled as a “gluten-free product” as long as they test <20ppm of gluten.

The CCA and Health Canada have both recommended that moderate amounts of pure and uncontaminated oats (<20ppm of gluten) may be consumed by most individuals with celiac disease.
(References: CCA position statements on Oats and the Health Canada Position Paper “Celiac Disease and Safety of Oats”).

4. Cross-contamination is a major issue with many naturally gluten-free grains and cereals and their flours and starches such as: buckwheat, millet, sorghum, teff, rice, corn and tapioca. The regulation must enable and encourage the use of ‘gluten-free’ labelling for these products if properly manufactured and tested so as to meet the <20 ppm gluten threshold. Likewise, naturally gluten-free seeds, legumes and nuts and their flours must be similarly treated. In other words, gluten-free on a food label should mean that a product has been tested to <20 ppm.

Additional Matters for Consideration
1. A gluten-free level of <20 ppm gluten gives Canadians with celiac disease a wide selection of affordable and safe choices in the marketplace because this regulation corresponds to a scientifically safe amount of gluten contamination chosen by other countries. This will also allow Canadian gluten-free product suppliers to distribute to other countries. The acceptance of the standard of <20ppm gluten for gluten-free products will help to remove trade barriers thereby allowing more choice for consumers and increased markets for Canadian manufacturers. The importance of this consideration with regard to the direction of regulation in the USA cannot be overstated.

2.The ultimate product of this policy intent and regulatory revision must be aligned and harmonized with the labelling for allergens and ‘oats’ should be removed from the definition of “gluten” in proposed Schedule 1220 Enhanced Labelling for Food Allergens and Gluten Sources and Added Sulphites.

3. Health Canada must also take the necessary steps to ensure that the resulting regulatory definition of ‘gluten-free’ be extended consistently to Pharmaceutical, Cosmetic, Natural Health Products, beverages, oral hygiene

4. While recognizing the work of Codex, the CCA does not support the use of the definition of “very-low gluten” (<100 ppm gluten) and any subsequent labelling. The data to support safety of gluten free products above a level 20 ppm gluten are inconsistent. There does not seem to be consistency with the use of this term internationally. The term “very-low gluten” labelling may add to consumer confusion.

5. Products derived from wheat, rye, or barley that meet < 20ppm gluten threshold as a result of various forms of special processing present some unique challenges to establishing and administering a clear regulation. Products such as maltodextrin, glucose syrup and dextrose derived from wheat, rye or barley are some examples of products that can meet that standard. Wheat starch is another. These products may be considered as safe ingredients in products which themselves meet the <20ppm threshold.
Our goal is that any proposed regulatory change must first satisfy basic food safety concerns. It must then address the issue of confusion when gluten-free products include ingredients derived from wheat, rye, and barley.

We recognize when wheat, rye or barley appear on an ingredient list in a gluten free product, even if labelled as <20 ppm, many consumers will be confused. This will need to be the focus of consumer and manufacturer education campaigns. The consumer will need to be educated that <20ppm is gluten-free and safe for individuals with celiac disease.

We do not have a solution to this dilemma, but offer to continue to work within the consultative process to determine the best approach.”

6. While this consultation on regulatory change will be ongoing and not likely completed in the short term, it is also imperative that Health Canada and CFIA agree on a consistent interpretation of the current regulatory requirement and publish this interpretation as a guideline for industry and the consumer.

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