Risk-based allergen labeling: reference doses, Japan's 10-ppm policy, and emerging challenges

To summarize current advances in risk-based management of unintended food allergen presence, with a particular focus on Japan's unique 10-ppm labeling threshold and precautionary allergen labeling (PAL) prohibition, and to contextualize these within emerging international frameworks based on eliciting doses (EDs) and reference doses (RfDs).

Quantitative risk assessment has shown that the aforementioned threshold offers a wide safety margin for most consumers allergic to egg, milk, and wheat, with estimated inadvertent exposures below the FAO/WHO RfDs. However, this threshold is associated with overly stringent requirements and a substantial management burden for some allergens, such as crustaceans. The FAO/WHO guidelines, Voluntary Incidental Trace Allergen Labeling (VITAL) 4.0, Codex, and regional initiatives are converging on ED-based RfDs alongside HACCP-based allergen management. In Japan, rapid shifts in nut consumption have altered allergy prevalence and ED distributions, highlighting the need for periodic threshold updates.

Future allergen policy should integrate robust thresholds with realistic, HACCP-based allergen management in packaged foods and food-service settings, anticipate shifting dietary patterns, and support internationally harmonized, evidence-based PAL that enhances the safety and quality of life of food-allergic individuals.