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Updated: May 4, 2026

Humanized Mediator Release Assay as a Read-Out for Allergen Potency
Published on: June 29, 2021
Risk-based allergen labeling: reference doses, Japan's 10-ppm policy, and emerging challenges
Tatsuki Fukuie1, Hiroshi Akiyama2
1Allergy Center, National Center for Child Health and Development.
Japan
Area of Science:
- Food science and safety
- Allergen management
- Risk assessment
Background:
- Current food allergen management practices
- Japan's 10-ppm threshold and PAL prohibition
- International frameworks for allergen labeling
Purpose of the Study:
- Summarize advances in risk-based allergen management
- Analyze Japan's unique labeling threshold and PAL prohibition
- Contextualize findings within international ED/RfD frameworks
Main Methods:
- Quantitative risk assessment
- Review of international guidelines (FAO/WHO, VITAL 4.0, Codex)
- Analysis of Japanese dietary shifts and allergy prevalence
Main Results:
- Japan's 10-ppm threshold provides a wide safety margin for common allergens but is burdensome for others (e.g., crustaceans)
- International convergence on ED-based RfDs and HACCP-based allergen management
- Shifting nut consumption in Japan necessitates threshold updates
Conclusions:
- Future allergen policy requires integrated thresholds and HACCP-based management
- Anticipate dietary pattern shifts and support harmonized, evidence-based PAL
- Enhance safety and quality of life for food-allergic individuals
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