To gluten and beyond!

Gluten-free foods in Canada have been regulated as foods for special dietary use in Division 24 in the Food and Drug Regulations (FDR) for the past two decades. Originally such a claim was prohibited when the food contained wheat, (including spelt and kamut), barley, rye, triticale and oat ingredients or parts thereof. In 2011 this was aligned with the definition of gluten that came as part of Canada’s food allergen, gluten and sulphites labelling regulations.

The current FDR prohibits food being represented in a manner that suggests it is gluten-free when it contains added gluten protein, protein fraction or modified protein from wheat, barley, rye, triticale and oats. As a food for special dietary use it must be specifically formulated or processed to meet the needs of a person that as the result of disease, disorder or injury needs to manage a physical or physiological condition. It also includes food in which a controlled intake is needed to have a particular effect.

In November 2014 Health Canada published a notice of intent to issue a marketing authorization (MA) that would permit gluten-free claims for foods containing specifically produced gluten-free oats. This would better align Canadian considerations with those in the U.S. There are, however, still some unique Canadian peculiarities. The MA, if finalized, would not amend current gluten-free regulations. What this would accomplish is an exemption to the current prohibition on oats, when gluten-free representations are made. All other FDR requirements would be maintained. It should be noted that gluten-free claims would still be prohibited when oats are used that are not specifically produced as gluten-free oats.

A few highlights from Health Canada’s intent to create an MA include a requirement that the food contain no other oat ingredient except for specifically produced gluten-free oats, which in turn are not permitted to contain more than 20 ppm of gluten from wheat, rye, barley and triticale. In addition, a gluten-free food to which specifically produced gluten-free oats are added may not contain more than 20 ppm of gluten, nor any intentionally added gluten from wheat, rye, barley and triticale gluten. All references to oat on the label, including in the ingredient list, must be clearly identified as gluten-free oats.

Why prioritize this MA amidst all the regulatory modernization now underway? During the 2011 amendments, Health Canada was aware of the mounting scientific evidence supporting the safety of specifically produced oats when consumed by most individuals with celiac disease. There was not enough time to make changes, without causing further delay in introducing food allergen, gluten and sulphites labelling. This brings us to the second part of this story, MAs, which as a regulatory instrument have interests beyond gluten.

The history of making regulatory changes in Canada can be summarized by the phrase “painfully slow.” In the case of this gluten amendment, Health Canada is exercising its new-found regulatory instrument, MAs. The authority to create regulations is provided by parliament, expressed in the Food and Drugs Act (FDA). In 2012 the FDA was amended to grant authority to the minister of Health to issue MAs. These are ministerial regulations, which escape the much slower classical governor in council (GIC) regulatory process. A number of food-related MAs have already been created, including the 15 that now govern food additives in tandem with the FDR. MAs are regulations under the FDA. They are separate from and are not consolidated under the FDR. Another feature of MAs is that they can, if need be, incorporate documents by reference (IbR) like regulations in the FDR. This was done in the case of the 15 food additive MAs.

While MA’s are published in Canada Gazette II, there is no obligation to pre-publish them in Canada Gazette I. In conventional GIC regulations, consultations are first held, followed by pre-publication in Canada Gazette I, then registration as regulations and publication in Canada Gazette II. MAs allow Health Canada to do pretty much the same thing, but in a much shorter and less painful way. To achieve the same level of openness and transparency, the ministry uses different means to deliver and manage information, such as the notice of intent related to gluten-free oats. This opens up various flanks of information industry must maintain awareness on. In addition, where any document is IbR, industry must also be actively aware of changes. As a trade-off for speed and efficiency in regulatory reform, industry must develop and maintain greater information competencies.

Regulatory in the future will no longer be a sit down dinner with a main course, but is more like a buffet’s smorgasbord. Bon appétit!

Gary Gnirss is a partner and president of Legal Suites Inc., specializing in regulatory software and services. Contact him at president@legalsuites.com