2013-2014 Undeclared Milk in Soy-Based Infant Formula

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 milk in soy-based infant formula, and to identify potential food safety concerns related to undeclared milk for the allergic and sensitive population.

A wide variety of soy-based infant formula is available on the Canadian market. In some cases, undeclared milk may be present in these products due to incomplete labelling or cross-contamination prior to or during manufacture of the final product, which may indicate a breakdown in good manufacturing practices or allergen controls. The presence of undeclared milk in a food may represent a serious or life-threatening health risk for allergic or sensitive individuals.

For this survey, 199 samples of soy-based infant formula were collected and analyzed for the milk proteins beta-lactoglobulin and casein. Soy-based infant formula sampled in this survey included powder and liquid concentrate products that did not declare milk in the list of ingredients. All samples contained at least one statement indicating that the product did not contain milk (e.g., free of lactose, no milk products or milk proteins, recommended for babies who cannot consume milk-based products). A precautionary statement indicating that products were manufactured on equipment also used to process dairy was present on 111 (55.8%) of the samples. Two (1.8%) of these samples tested positive for casein; both samples were from the same production lot. None of the remaining 88 samples tested positive for milk.

Both positive results were evaluated by the CFIA, taking into account the fact that not all detectable levels of undeclared milk pose a risk to consumers. The CFIA initiated appropriate risk management actions based on health risk assessments by Health Canada. Actions may include 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 other stakeholders of its findings.

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