Information for Canadians with Soy Allergy

January 2013


Health Canada would like to inform Canadians with soy allergies that cereal grains, such as wheat, oats or barley, may contain low levels of soy because of the way these grains are grown, harvested, transported and stored.  This cross contamination, or adventitious presence, is not a new issue, but rather has always been present as part of normal agricultural practices. The possibility of this adventitious presence is reflected in  cereal grain quality grading standards.

Based on the low levels of soy that have been detected in grain-based foods, Health Canada has determined that exposure is not likely to represent a health risk for soy allergic individuals. As such, the department has advised the food industry that the use of food allergen precautionary labelling, in cases where low levels of soy present in grain-based foods has been determined to be due to adventitious presence, is not considered to be the best approach, and would not benefit the interests of soy allergic consumers as it would potentially limit food choices.


In late 2012, Health Canada organized a meeting between representatives of the federal government (Health Canada, the Canadian Food Inspection Agency (CFIA), Agriculture and Agri-Food Canada (AAFC), the Canadian Grain Commission (CGC), the food industry and Anaphylaxis Canada).  At issue was the potential for low levels of soy to be present in wheat and foods containing wheat ingredients due to the way that grains are grown, harvested, transported and stored.  A key focus at the meeting was what measures could or should be taken to protect individuals allergic to soy, whether food allergen precautionary labelling, specifically, use of the statement "may contain soy", was warranted for flour and other wheat based products.

In general, when a precautionary statement appears on an ingredient used in the manufacture of a prepackaged food, this statement is often carried forward onto the prepackaged food itself.  If food allergen precautionary labelling for soy was added to the labels of flour and other wheat based ingredients, then a very large number of products which use wheat or wheat derivatives as ingredient(s) would also begin to have precautionary labelling for soy listed on their labels. This would make it more difficult for soy allergic individuals to find safe choices of food to eat.  In addition, seeing this kind of precautionary labelling on products that have been available without such labelling for many years, and whose formulation has not changed, would likely be confusing. Health Canada has consulted with major food allergic patient associations and has not been made aware of any reports of adverse reactions in soy allergic individuals caused by the inadvertent presence of low levels of soy in wheat. 

Health Canada's policy for enhancing the protection of food-allergic consumers in Canada is based on two guiding principles:

  1. prevent the inadvertent consumption of undeclared allergens by sensitive consumers;
  2. enable a variety of safe and nutritious food choices for the allergic consumer.

The policy supports the appropriate use of food allergen precautionary statements on pre-packaged foods, as a risk management tool, where warranted.

Health Canada's position on food allergen precautionary labelling indicates that the Department considers the use of allergen precautionary statements to be a useful tool in mitigating adverse reactions to priority food allergens if the statements are used appropriately. Additionally, the Department provides the guidance that precautionary labelling should only be used when, despite all reasonable measures, the inadvertent presence of allergens in food is unavoidable.

In late 2012, Health Canada initiated a two year process to gather information and data necessary to fully evaluate the issue of soy in wheat and to develop standards and guidance for industry regarding appropriate labelling.  To support the development of these standards and guidance, Health Canada will be working with various stakeholders from the food industry and food allergy associations to gather more information about the unintended presence of soy in wheat, the range of levels of soy that can be found in wheat based products, as well as clinical data regarding the levels of soy that are associated with adverse reactions in allergic individuals. 

Currently, Health Canada is advising the food industry that precautionary labelling for soy on wheat based products, unless it is warranted by specific concerns regarding allergen controls and possible cross contamination at the manufacturing level, is not considered an appropriate response to this issue.  Based on the limited information available at this time, the use of a "may contain"  statement on flour and other wheat based products in response to the inadvertent presence of low levels of soy is also not expected to be of benefit  to the soy allergic community.

For more information on this initiative, please contact the Food Directorate's Bureau of Chemical Safety at

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