Food allergens are critical food safety hazards for manufacturers, regulators, and allergic consumers. Despite many improvements in recognition of the importance of food allergen management, undeclared food allergens remain the most frequent cause of recalls in the U.S. At the same time, there has been no apparent slowdown in the use of precautionary allergen labeling (PAL), also commonly known as "may contain" labeling. To some extent, both outcomes result from the absence of regulatory thresholds for food allergens, which leads to zero-tolerance approaches to allergen management decisions.
Risk-based approaches for food allergens offer a path forward for both allergen management and PAL decision-making. After many years of research, a clearer picture has emerged of the population-level, threshold-dose distributions for major food allergens using data generated in double-blind, placebo-controlled food challenge studies. In other words, the risk assessment community has a better understanding of the amounts of food allergens that are likely to cause reactions in allergic individuals. Notable initiatives to structure the implementation of risk-based approaches for food allergens include the Voluntary Incidental Trace Allergen Labelling (VITAL) Program from the Allergen Bureau, and ongoing meetings of the ad hoc Food and Agriculture Organization of the United Nations (FAO)/World Health Organization (WHO) Expert Consultation on Risk Assessment of Food Allergens. These efforts have provided clarity on the application of scientific evidence for food allergen risk assessment, which may ultimately lead risk managers and regulatory authorities to develop quantitative action levels for food allergens. If action levels are established, a critical question will be: Can we reliably and accurately quantify food allergens at those action levels?