2013-2014 Soy in Pre-Packaged Grain-Based Foods

Executive Summary

Targeted surveys are used by the Canadian Food Inspection Agency (CFIA) to both support the prioritization of the Agency's activities to areas of greater concern and provide scientific evidence to address areas of lesser concern. Originally started under the Food Safety Action Plan (FSAP), targeted surveys have been incorporated into the CFIA's regular surveillance activities as a valuable tool for generating essential information on certain hazards in foods, identifying/characterizing new and emerging hazards, informing trend analysis, prompting/refining human health risk assessments, assessing compliance with Canadian regulations, highlighting potential contamination issues, and promoting compliance.

The main objectives of this targeted survey were to obtain baseline information regarding the presence and levels of undeclared soy in single and multiple ingredient prepackaged grain-based foods, and to identify potential food safety concerns related to undeclared soy for the soy-allergic population.

In Canada and in other countries, as part of normal and long-standing agricultural practices, cereal grains are often grown in close proximity to other types of grains, oilseeds, and pulses. In addition, these other grains, oilseeds, and pulses can be harvested, stored, and transported using the same equipment and facilities as those used for cereal grains. Therefore, it is extremely difficult to keep low levels of different crops from getting mixed in with each other, and may lead to the adventitious, or inadvertent, presence of a food allergen, like soy, in other finished grain products (such as wheat-based foods). Soy may also be present in prepackaged food products as a result of cross-contamination prior to or during manufacturing, which may indicate a breakdown in good manufacturing practices or allergen controls.

The presence of an undeclared allergen (like soy) in a food may represent a serious or life-threatening health risk for allergic or sensitive individuals. Health risk assessments have determined that the low levels of soy due to adventitious presence would not be expected to cause a serious, adverse allergic reaction in those with a soy allergy. The Canadian Food Inspection Agency and Health Canada have advised manufacturers and importers that precautionary labelling for soy is not recommended on finished grain-based foods when a low level of soy is detected due to adventitious presence.

A total of 388 samples were collected and analysed for the presence of soy. Samples included a variety of prepackaged grain-based foods that did not declare soy either as an ingredient or in a precautionary statement. Products were either single ingredient (e.g., oat flour) or multiple ingredient finished foods (such as cookies). Of the 388 samples, 171 (44%) were positive for soy and nearly all of these positives were at a very low concentration. Comparing product types in the survey, wheat flours and baking mixes (many with wheat flour as a main ingredient) had the highest percentage of samples positive for undeclared soy, 54% and 71% respectively.

Since not all detectable levels of soy pose a risk to consumers, positive results were first considered by the CFIA for their potential risk. Appropriate follow-up actions were initiated that reflected the magnitude of the human health concern. Actions may include further analysis, notification to the producer or importer, follow-up inspection, additional directed sampling, a food safety investigation (which may involve a health risk assessment conducted by Health Canada), and recall of products.

The CFIA will continue its surveillance activities and inform the Canadian public and stakeholders of its findings.

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