Wednesday, June 20, 2012

Health Canada Releases New Guidelines for Gluten Free

As readers of this blog may know, we write a lot about gluten testing, dedicated facilities, and cross contamination. Readers may also know that, unlike the US, Canada has had regulations for the labelling and sale of gluten free foods for at least 20 years. This has been a huge benefit to Celiacs buying gluten free products made in Canada as there is rarely a question that a product labeled gluten free is safe (ie: contains less than 20ppm gluten).

The regulation was short and sweet consisting of one line.

"A food is not permitted to be labelled, packaged, sold or advertised in a manner likely to create an impression that it is "gluten-free" unless it does not contain wheat, including spelt and kamut, or oats, barley, rye, triticale or any part thereof."

Over the past couple of years or so, Health Canada has been consulting with the medical community, researchers, industry and consumers. It has come up with new guidelines to replace the old one line entry and modernize the regulations.

As of August 4, 2012, section B.24.018 of the Food and Drug Regulations will state that:

It is prohibited to label, package, sell or advertise a food in a manner likely to create an impression that it is a gluten-free food if the food contains any gluten protein or modified gluten protein, including any gluten protein fraction, referred to in the definition "gluten" in subsection B.01.010.1(1).
Subsection B.01.010.1(1) reads:
(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:
(i) barley,
(ii) oats,
(iii) rye,
(iv) triticale, or
(v) 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 subparagraphs (a)(i) to (v) or the grain of a hybridized strain referred to in paragraph (a). (gluten)

Along with the regulations, they have published guidelines which offer interpretations of what this actually means.

The Mostly Good

One of the problems with the old one line regulation was that there have been some instances where the regulations were not entirely clear or conflicted with other regulations.

For example, it was not clear if seasonings that had some gluten containing carrier would have to list that carrier as an ingredient since one part of the food and drug regulations exempted companies for having to list components of seasoning, natural flavours and other similar ingredients. This has resulted in most Celiacs considering anything with these types of ingredients as off limits.

The new guidelines state:  "Based on the enhanced labelling regulations for allergens and gluten sources, any intentionally added gluten sources, even at low levels (e.g. wheat flour as a component in a seasoning mixture which makes up a small proportion of the final food), must be declared either in the list of ingredients or in a "Contains" statement. In these cases, a gluten-free claim would be considered false and misleading."

Health Canada has done a fairly extensive review of the literature and based on this, they have determined that the maximum safe level of gluten in a product is 20ppm. This has been the accepted standard in Canada for years, but this is a reaffirmation of that level.

Based on the available scientific evidence, Health Canada considers that gluten-free foods, prepared under good manufacturing practices, which contain levels of gluten not exceeding 20 ppm as a result of cross-contamination, meet the health and safety intent of B.24.018 when a gluten-free claim is made.

Now I know a lot of people will say that 20ppm is too much and that the number should be much smaller. I believe Health Canada is taking a view to risk vs. benefit; that for most Celiacs, the broader availability of products with the higher threshold outweighs the risk to the portion of the population that react at a lower level. For those who do react at lower levels or those who feel that level is too high, the only option is to look for companies like Kinnikinnick who test to < 5ppm.

One thing, that as a Celiac, I have some reservations about is "With respect to gluten-free foods, only those foods that have been specially processed or formulated to meet the needs of individuals, including individuals with Celiac disease, who need to follow a gluten-free diet in order to protect their health, are considered foods for special dietary purposes and are allowed to carry a gluten-free claim."

On one hand this is a good thing as it eliminates plainly silly claims such as water labeled gluten free, which I have seen. However, taken strictly, this might prevent a mass market company from labeling a product gluten free even if it is.

The guidelines do go on to say "If a food is determined to be protective of the health of people with Celiac disease, and meets the other requirements of Division 24 (specially processed and formulated), it follows that such a food should be able to use the claim "Gluten-free", as long as it is being done in a manner that is truthful and not misleading."

This seems to give companies who are not specifically targeting people with Celiac the ability to label a product gluten free, provided they meet the standards. If that is the intent then I think that's a good thing for Celiacs.

The Not So Good (possibly, actually quite bad)

The one thing in the regulations that raises some red flags is: "If, however, a manufacturer using a cereal-derived ingredient includes additional processing steps which are demonstrated to be effective in removing gluten, then the food may be represented as gluten-free."

My interpretation of this is that companies could be using ingredients based on gluten containing grains such as wheat starch, provided they test below the threshold of 20ppm. If this is the case, this is concerning from 2 perspectives.

Firstly, do we really need to add more confusion to what is gluten free by saying "completely avoid wheat, barley, rye and oats, (except if they are specially treated and contain less than 20ppm gluten)". What are newly diagnosed Celiacs to make of that? How is it regulated, tested and enforced?

Secondly, do we know that intentionally adding gluten based grains to gluten free foods isn't going to be harmful to more sensitive individuals? As with our position with oats (more on that in a minute), we think that intentionally allowing gluten containing grains to be added to gluten free foods is a very bad idea. Our position is that if it isn't safe for all celiacs, it shouldn't be allowed.

The Really Good

As readers will know, Kinnikinnick has been opposed to allowing the use of oats in gluten free foods (even when specially raised and harvested) due to confusion, unknown risks and a clinically proven number of Celiacs who can not tolerate oats in any amount. The link above, along with the comments to the post formed the basis of our submission to Health Canada opposing any change allowing oats in gluten free foods.

We are very pleased the new regulations continue the status quo and do NOT allow oats to be included in products labelled gluten free in Canada. As a Celiac, you will still have the ability to buy and consume oats if you choose to, but they won't be labeled gluten free. As we outline in our previous post, we believe it is a very good thing that Health Canada has kept oats off the gluten free table.

Not Perfect but Not Bad.

Overall, I think Health Canada has done a pretty good job of balancing all the various factors in coming up with the new regulations. For us as a company, it's business as usual. We'll keep producing products in our dedicated gluten free facilities, testing incoming ingredients and outgoing products to <5ppm and providing consumers the safest and best tasting products we can make. As a Celiac, I look forward to being even more confident in products acceptable for sale in Canada that are labelled gluten free.

Now, FDA, about those regulations due in 2008......