BOTTOM LINE: The Food and Drug Regulations ("Regulations") were amended on August 4, 2012, to include a definition for "gluten" as well as a new description of prohibited claims. Health Canada has also set out its position on the upper limits of gluten permissible (20 ppm), as well as acceptable testing methods for gluten detection.

As "gluten-free" food claims continue to proliferate wildly, Health Canada's new "Position on Gluten-Free Claims" was incorporated into legislation on August 4, 2012. Welcomed by many, it provides a more detailed approach to "gluten-free" regulation.

WHAT'S THE GLUTEN ISSUE?

Individuals with celiac disease experience a wide range of reactions from ingesting foods that contain gluten. Gluten is found in sources such as oat, rye, wheat or barley, but can also migrate into other foods through cross-contamination during manufacturing or distribution. For those with Celiac's Disease, gluten can damage the small intestine, preventing the absorption of necessary nutrients. Other serious conditions can be related to Celiac's Disease, such as certain cancers and infertility.

There are also those who have Gluten "sensitivity." These people have many of the same symptoms as those with Celiac's Disease, but without the autoimmune response. "Gluten-free" claims are therefore regulated as protecting the health and safety of individuals who require the use of foods for special dietary use.

SO WHAT'S NEW?

Previously, the Regulations did not define â€Ügluten' and simply restricted "gluten-free" claims to products that did not contain wheat, spelt, kamut, oats, barley, rye or triticale or any part thereof. Given the realization that it is the protein portion of the cereal grains that is of concern, the regulatory amendments now prohibit "gluten-free" claims (or creating the impression that a food is gluten-free) when the food contains any gluten protein or modified gluten protein, including any gluten protein fraction referred to in the definition of "gluten".

The new definition of "gluten" is: (a) any gluten protein from the grain of any of the following cereals or the grain of a hybridized strain created from at least one of the following cereals: barley, oats, rye, triticale or wheat, kamut or spelt, or (b) any modified gluten protein, including any gluten protein fraction, that is derived from the grain of any of the cereals referred to in (a) or the grain of a hybridized strain referred to in (a). Say that fast ten times!

IS THERE ANY TOLERANCE? AND HOW IS IT TESTED?

As a practical matter, there is a tiny bit of tolerance. Although the Regulations still don't speak to this.

Health Canada's administrative position is that foods labelled "gluten-free" may contain up to 20 parts per million of gluten. As for test methodology, while Health Canada has not specified a standard for gluten detection testing, it generally endorses ELISA-based methodologies such as the R5 (Mendez) ELISA. Health Canada will likely be codifying these administrative positions in the future, so keep your eyes peeled for new announcements.

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