Vol. 149, No. 11 — June 3, 2015

Registration

SOR/2015-114 May 19, 2015

FOOD AND DRUGS ACT

Marketing Authorization for Gluten-free Oats and Foods Containing Gluten-free Oats

The Minister of Health, pursuant to sections 30.2 (see footnote a) and 30.3 (see footnote b) of the Food and Drugs Act (see footnote c), issues the annexed Marketing Authorization for Gluten-free Oats and Foods Containing Gluten-free Oats

Ottawa, May 15, 2015

RONA AMBROSE
Minister of Health

MARKETING AUTHORIZATION FOR GLUTEN-FREE OATS AND FOODS CONTAINING GLUTEN-FREE OATS

INTERPRETATION

Definitions

1. The following definitions apply in this Marketing Authorization.

“gluten” means

“p.p.m.” means parts per million by weight. (p.p.m.)

EXEMPTIONS

Representation or advertisement — gluten-free oats

2. Any representation about gluten on the label of a food that is oats or that contains oats, and an advertisement for the food is exempt from the application of section B.24.018 of the Food and Drug Regulations if

Source of gluten

3. A food that is oats or that contains oats and that satisfies the conditions set out in section 2 is exempt from the application of section B.01.010.1 and subparagraph B.01.010.3(1)(b)(ii) of the Food and Drug Regulations in respect of the requirement to show the source of gluten from oats.

Name for oats

4. A food that is oats or that contains oats and that satisfies the conditions set out in section 2 is exempt from the application of subsection B.01.010(2) of the Food and Drug Regulations in respect of the name by which oats are shown as an ingredient or component in the list of ingredients for the food.

COMING INTO FORCE

Registration

5. This Marketing Authorization comes into force on the day on which it is registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Marketing Authorization.)

Issues and objectives

Gluten is a family of proteins found in some cereal grains including wheat, barley, rye and oats. For individuals with celiac disease, the consumption of dietary gluten results in adverse health effects, many of which may be serious. Currently, the only treatment for celiac disease is to follow a strict gluten-free diet (GFD) for life.

In 1995, section B.24.018 of Canada’s Food and Drug Regulations (FDR) was promulgated to protect the health of individuals with celiac disease by providing limits on the use of the term “gluten-free.” Updated in 2012, it 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 protein. Subsection B.01.010.1(1) of Canada’s FDR currently defines gluten as being any gluten protein or modified gluten protein, including any gluten protein fraction, created from barley, oats, rye, triticale, wheat, or their hybridized strains. This prohibition and definition reflect the understanding of celiac disease at the time the Regulations were issued. Individuals with celiac disease must avoid wheat, barley, rye and other closely related cereals in a GFD. Historically, oats have also been excluded from the GFD, however the understanding of celiac disease has advanced since the Regulations were first developed. Common agricultural practices, including the harvesting, storage, transportation, and processing of oats in the same facilities as wheat, rye, and barley, results in cross-contamination or co-mingling of these different grains. More recently, whether or not individuals with celiac disease can safely consume oats as part of a GFD has been an issue of interest and scientific investigation. In 2007, based on an extensive review of the scientific literature related to the safety of oats in a GFD, Health Canada concluded that the majority of people with celiac disease can tolerate moderate amounts of oats that are uncontaminated with gluten proteins from other cereal grains such as wheat, barley and rye.

A marketing authorization (MA) for “gluten-free” oats will increase the availability of innovative and safe products for individuals with celiac disease in Canada, and make these products easier to identify. The MA will exempt specially produced and processed oats, or specially processed oats, containing no greater than 20 parts per million (p.p.m.) of gluten from wheat, barley, rye, or hybridized strains of these cereals, and foods containing these oats as an ingredient, from the prohibition against making “gluten-free” claims if certain conditions are met. The “gluten-free” claim on such oats would otherwise be prohibited under the FDR. The MA will also exempt these specially produced and/or processed oats from section B.01.010.1 as it applies to gluten. This section defines gluten and requires that the source of allergens and gluten be shown on the label of prepackaged products. This section would still apply to prepackaged products containing “gluten-free oats” with respect to other food allergens. Finally, the MA will exempt gluten-free oats from the requirement in subparagraph B.01.010.3(1)(b)(ii) to show oats as a source of gluten on a label.

Rationale and description

Science has evolved since the drafting of the current Regulations, and evidence now shows that avenin, the gluten protein found in oats, which is structurally different from the gluten found in other cereals, is not a health risk for the majority of individuals with celiac disease. Current scientific data supports Health Canada’s conclusion that it is safe for people with celiac disease to consume specially produced or processed oats, as long as the oats do not contain more than 20 p.p.m. of gluten from wheat, barley, rye, or hybridized strains of these cereals. This includes foods prepared using those specially produced or processed oats, as long as the finished product also does not contain more than 20 p.p.m. of gluten from these cereals. It is believed that the use of the gluten-free claim on foods containing specially produced and/or processed oats would broaden the range and variety of food choices and provide increased health benefits with regard to their diet for the majority of individuals with celiac disease.

For the purpose of this MA, “gluten-free oats” means oats that are produced and processed in such a way as to avoid the presence of gluten from wheat, barley, rye, or hybridized strains of these cereals, in an amount exceeding 20 p.p.m., as well as oats that have been specially processed in a manner to limit or reduce contamination by gluten from wheat, rye, barley, or their hybridized strains, and do not contain more than 20 p.p.m. of gluten from any of these sources.

The marketing authorization for “gluten-free oats” will

Division 24 of Part B, and all other applicable requirements under the Food and Drugs Act and its Regulations will continue to apply.

Consultation

In the summer of 2010, Health Canada consulted stakeholders on gluten-free labelling. At that time, Health Canada invited stakeholders to provide input on proposed principles for guiding the revisions of Canada’s gluten-free labelling policy. This was an online consultation which focused on the safety of oats, and asked stakeholders to identify other issues that should be considered with regards to potential changes to Canada’s gluten-free labelling policy. This initial consultation generated comments from 131 stakeholders, the majority of which expressed support for the proposed principles. Information about the current proposal was published in a notice of intent on November 14, 2014, for a 75-day comment period. A total of 13 comments were received during this period, all of them positive. Stakeholders expressed support for the proposal, and a need for an accompanying educational campaign was highlighted in several of the comments. Further consultation is not considered necessary at this time.

“One-for-One” Rule

The “One-for-One” Rule does not apply to this proposal, since the administrative costs remain the same for businesses, and the impact of the marketing authorization is administratively neutral.

Small business lens

The small business lens does not apply to the proposal, since the Marketing Authorization creates an exemption to a prohibition in the FDR if certain conditions are met and does not impose additional costs on small businesses.

Implementation, enforcement and service standards

The proposed amendment will be incorporated into existing compliance and enforcement activities carried out by the Canadian Food Inspection Agency (CFIA) under the provisions of the Food and Drugs Act and its Regulations, and other applicable food related legislation enforced by the CFIA.

Consumer education and awareness efforts will be a part of the implementation strategy in order to inform consumers that oats that meet the conditions of this MA, and food containing such oats as ingredients, will be eligible to carry gluten-free claims. Health Canada will work with the relevant consumer associations (e.g. Canadian Celiac Association) to facilitate consumer awareness of this change. In addition, Health Canada will post information about the MA on its Web site and will notify stakeholders about the MA through the usual channels.

Contact

Dana Wang
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Tower B, 5th Floor
1600 Scott Street
Ottawa, Ontario
K1A 0K9
Fax: 613-941-7104
Email: LMR_MLR_consultations@hc-sc.gc.ca