D2.313 - Scientific Evidence Gaps in FAO/WHO Food Allergen Threshold Guidance: Implications for Risk Assessment and Regulatory Decision-Making

International initiatives led by the Food and Agriculture Organization and the World Health Organization have attempted to define reference doses for priority allergens to improve consistency in allergen management. These thresholds are intended to support food industry practices and help regulators determine when advisory labelling is necessary and when products may require withdrawal or recall from the market. However, the scientific assumptions, data transparency, and methodological approaches used in these recommendations remain the subject of ongoing debate within the scientific and clinical community.

A technical review was conducted of the FAO/WHO food allergen threshold guidance and related public consultation documents, including FDA Docket FDA‑2021‑N‑0553. Based on this review, a technical comment was prepared for submission. The sources included published FAO/WHO threshold reports, materials from the February 2026 public webinars, and peer-reviewed literature on IgE-mediated food allergy.

The review assessed study populations, age groups, food matrices, recorded symptom to define the individual thresholds levels, and statistical methods used for deriving thresholds at population levels. Published literature was also compared to these reports to evaluate consistency and robustness. The FAO/WHO guidance presents expert recommendations on food allergen thresholds; however, the basis for these recommendations is not fully transparent. Information on the resources and underlying data are not publicly available, preventing independent verification by experts outside the consultation. These gaps raise concerns about the robustness of the guidance and its implications for precautionary allergen labeling (PAL) and product recalls, with potential public health consequences.

Recommendations and guidelines should incorporate additional considerations until methodological uncertainties are resolved, and raw data, metadata, statistical methods, analytical methods should be accessible to allow independent verification and ensure thresholds are protective for all allergic consumers