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Food and Nutrition

Notice of Intent to Issue a Food Marketing Authorization - Proposed Marketing Authorization to allow gluten-free claims for specially produced "gluten-free oats" and products containing such oats under certain conditions

Notice to the reader: The online consultation is now closed. Please see Consultation Summary: Notice of Intent to issue a Food Marketing Authorization to Allow Gluten-Free Claims for Specially Produced Gluten Free Oats and Products Containing Such Oats [2015-05-29]

November 14, 2014

Purpose

The purpose of this notice is to inform Canadians and other interested stakeholders of the intent of the Minister of Health to issue a Marketing Authorization (MA) to allow gluten-free claims for specially producedFootnote 1 oats that do not contain more than 20 parts per million (ppm) of gluten from wheat, rye, barley, or their hybridized strains, and for foods containing these "gluten-free oats" as ingredients when sold in Canada.

Background

Celiac disease is a chronic, immune-mediated disease, observed in susceptible individuals, for which the symptoms are triggered by exposure to dietary gluten. Gluten is the main protein component of wheat, with equivalent proteins found in other cereals, including barley and rye and their hybridized strains. A strict lifelong avoidance of gluten sources in the diet is the only effective way to manage this disease and prevent adverse health effects.

Grains containing gluten are widely used in the production of many foods. Gluten can be present in a food as a result of the food's manufacture using ingredients that are sources of gluten. Its presence can also be due to cross contamination of gluten from one grain to other cereal grains as a result of accepted agricultural practices during harvesting, transport and storage. Careful review of food labels and an accurate listing of food ingredients are essential for individuals with celiac disease to determine if gluten-containing ingredients are present. The appropriate use of gluten-free claims on foods allows individuals with celiac disease to readily identify products that they can consume safely.

Historically, individuals with celiac disease have been advised to avoid the ingestion of the gluten protein found in wheat, barley, rye, or their hybridized strains, and oats. In recent years, the safety of oats for those with celiac disease has been an issue of interest and investigation. In 2007Footnote 2, an extensive review of the scientific literature led Health Canada to conclude that the majority of individuals with celiac disease could tolerate limited amounts of oats uncontaminated with wheat, barley, rye or their hybridized strains and that the consumption of such oats could be nutritionally beneficial to individuals with celiac disease who tolerate them. Oats are an important source of proteins and carbohydrates, especially fibre, and would permit a wider choice of grain and cereal-type foods for individuals with celiac disease. In addition, its palatability could help increase compliance with a gluten-free diet. The recommendation at the time was to limit consumption of uncontaminated oats to 20-25 grams per day for children and to 50-70 grams per day for adults, as these were the amounts consumed in the relevant studies. There was no evidence that levels higher than those recommended would be unsafe.

A review of the available scientific literature conducted in 2014 concluded that there is no basis to recommend that individuals with celiac disease limit their consumption of specially produced oats that do not contain more than 20 ppm of gluten from wheat, rye or barley or their hybridized strains. Additional information on this review and the scientific evidence supporting this regulatory proposal can be found at: Celiac Disease and Gluten Free Claims on Uncontaminated Oats.

The Canadian Celiac Association position statement on oats supports the safety of specially produced oats that are free from gluten from wheat, rye and barley for most individuals with celiac disease.

International Context

The Codex Standard for Foods for Special Dietary Use for Persons Intolerant to Gluten (Codex Stan 118-1979) was revised in 2008 to recognize that oats can be tolerated by most people who are intolerant to gluten and states that the decision whether to allow uncontaminated oats in foods with a gluten-free claim may be determined at the national level.

In 2009, the European Union adopted a regulation based on the Codex standard. Under this regulation, uncontaminated oats are "oats that have been specially produced prepared and/or processed in a way to avoid contamination by wheat, rye, barley, or their crossbred varieties and the gluten content of such oats must not exceed 20 ppm".

Similarly, the U.S. Food and Drug Administration issued a final ruling in 2013 allowing "gluten-free" claims on oats provided they contain less than 20 ppm of gluten.

Regulatory Requirements for Gluten-free Foods

Canada's Food and Drug Regulations currently prohibit the use of gluten-free claims on any foods containing gluten protein, including modified gluten protein, derived from the grain of barley, oats, rye, triticale, wheat, or from a hybridized strain of these cereal grains. Specifically, section B.24.018 of the Regulations prohibits the labelling, packaging, sale or advertising of a food in a manner likely to create an impression that the food is gluten-free if the food contains any gluten protein or modified gluten protein, including any gluten protein fraction, referred to in the definition "gluten" appearingin subsection B.01.010.1 (1) of the Regulations.

The current body of scientific evidence supports the safety, for most individuals with celiac disease, of consuming specially produced oats provided that these oats do not contain more than 20 ppm of gluten from wheat, rye, barley or their hybridized strains. This includes foods prepared using these specially produced oats as ingredients, provided that the finished product does not contain more than 20 ppm of gluten from wheat, rye or barley. It is considered that the use of gluten-free claims on such foods would broaden the range of food choices and provide a nutritional benefit for the majority of individuals with celiac disease.

Proposed Marketing Authorization

Pursuant to section 30.2 of the Food and Drugs Act, it is the intention of the Minister of Health to issue a Marketing Authorization to permit the use of gluten-free claimsFootnote 3 for specially produced oats that do not contain more than 20 ppm of gluten from wheat, rye, barley, or their hybridized strains, and for foods containing such oats as ingredients, under certain conditions.

The proposed MA will function by creating an exemption from the relevant prohibition(s) under the Food and Drug Regulations provided that:

  1. The food contains no oats other than specially produced "gluten-free oats";
  2. The finished product does not contain greater than 20 ppm of gluten from wheat, rye, barley or their hybridized strains;
  3. The food contains no intentionally added gluten from wheat, rye, barley, or their hybridized strains; and
  4. The "gluten-free oats" are clearly identified as such in all cases where 'oats' are referenced, including in the list of ingredients.

The identification of specially produced oats as "gluten-free oats" aims to clearly inform the consumer that they are different from regular oats. Regular oats are those that have not been specially produced to contain 20 ppm or less of gluten from wheat, rye, barley, or their hybridized strains and should not be consumed by individuals with celiac disease. The unique identification as "gluten-free oats" will help ensure that individuals with celiac disease do not think that all oats are safe for them to consume, thus helping to prevent the accidental consumption of regular oats and mitigating the risk of potential adverse effects to their health.

All other requirements of the Food and Drugs Act and its regulations would be maintained.
Associated Governor in Council regulations are being developed in order to modify existing provisions in the Food and Drug Regulations pertaining to gluten-free to ensure the greatest level of clarity and coherence between the Regulations and this MA.

The proposed MA would be an enabling measure. It would come into force the date on which it is published in the Canada Gazette, Part II.

Public Comments

Interested persons may make representations, with respect to the Minister of Health's intent to issue this MA, within 75 calendar days, commencing November 14, 2014 and closing on January 27, 2015. All such representations must cite the title, reference number and the publication date of this notice, and be addressed to the contact identified below.

Contact

Dionne Saul-Hamilton
Office of Legislative and Regulatory Modernization
Health Canada
1600 Scott Street - Tower B
Ottawa, Ontario
K1A 0K9

Fax: (613) 941-7104
E-mail: lrm-mlr@hc-sc.gc.ca

Footnotes

Footnote 1

Oats that are grown, transported, stored, prepared and/or processed in a manner that avoids cross-contamination by wheat, barley, rye, or their hybridized strains, or oats that are processed in a way that effectively removes cross-contamination by wheat, barley, rye, or their hybridized strains.

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Footnote 2

See Health Canada's position on the Introduction of Oats to the Diet of Individuals Diagnosed with Celiac Disease (2007).

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Footnote 3

Any representation likely to create an impression that a food is gluten-free.

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