Risk Assessment of Trace and Undeclared Allergens in Processed Foods

In the absence of guidance from public health authorities regarding food allergen thresholds, the food industry has implemented the widespread use of various forms of voluntary advisory or precautionary “may contain” labeling in an attempt to manage the risk and protect food-allergic consumers. All stakeholders (regulators, food industry, clinical researchers and food-allergic consumers) agree it is essential to address the current lack of action levels and thresholds for food allergen labeling as the ramped use of advisory labeling and lack of transparency of its use limit food choices and decrease the quality of life of allergic individuals. This study aims to build upon initial work with peanut and develop a global thresholds database for all priority food allergens. Clinical publications and unpublished clinical data were screened for data regarding objective, individual challenge data for priority food allergens. Minimal eliciting doses were found for 13 priority allergens and include over 1800 individuals from published clinical literature or unpublished clinical data. The results of this study show there are sufficient clinical data from food allergic individuals to use for risk assessment purposes and developing regulatory thresholds for several allergenic foods. Allergic populations did not vary when analyzed by age, geographic region, or gender and only slightly varied by study population and challenge material. Expert judgment must be used when developing regulatory thresholds or action levels (reference doses) and evaluating the clinical challenge methods that provide data on relevant food allergic-individuals. In order to benefit all stakeholders, clinical food challenge studies are recommended to start below 1 mg protein from the allergenic food and proceed at a log or semi-log scale dose increases,