Allergen Eliciting Dose Thresholds
Evidence-based population-level eliciting doses (ED01, ED05, ED10) for major food allergens, drawn from authoritative scientific and regulatory sources including the VITAL® Program, FAO/WHO Expert Consultations, ILSI Europe, EuroPrevall, NIH/NIAID, FDA, and FARRP.
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Threshold values are based on published population-level research and are intended for educational purposes only. Individual reactions vary widely. People with food allergies should always follow the guidance of their allergist and avoid allergens according to their personalized medical advice.
ED01 = eliciting dose predicted to provoke a reaction in 1% of the allergic population. ED05 = 5%. ED10 = 10%.
All doses are expressed in milligrams (mg) of total allergenic protein unless otherwise noted. Thresholds represent population estimates and should never be used to determine an individual's safe exposure level.
What you're viewing
- Ingredient labels are what manufacturers print on packaged food (e.g., "Contains: Milk"). They list declared allergens — not the actual amount of allergenic protein present.
- Clinical eliciting dose is the amount of allergenic protein predicted to trigger a reaction in a given percentage of an allergic population (ED01, ED05, ED10). These come from controlled clinical food-challenge studies, not from product labels.
- Scientific threshold research synthesizes those clinical studies into population-level reference doses (e.g., VITAL®, FAO/WHO). Thresholds are statistical estimates for populations — never a personal "safe" exposure level.
Manufacturers generally do not publish eliciting-dose thresholds for their products. The values here come from peer-reviewed research and authoritative bodies, not from food companies.
FDA Regulatory Context
The U.S. Food and Drug Administration (FDA) regulates the labeling of major food allergens under the Food Allergen Labeling and Consumer Protection Act (FALCPA, 2004) and the Food Allergy Safety, Treatment, Education, and Research Act (FASTER Act, 2021). FDA labeling rules are regulatory thresholds — they are distinct from the clinical ED01/ED05/ED10 eliciting-dose values shown in this table, which come from scientific dose-distribution research (VITAL®, FAO/WHO). The FDA does not currently publish population-level eliciting doses for individual allergens.
Nine major food allergens recognized by the FDA
Sesame became the 9th major food allergen on January 1, 2023 under the FASTER Act.
FDA "gluten-free" labeling threshold
For a food to bear a "gluten-free" claim, the FDA requires that unavoidable gluten be present at less than 20 parts per million (ppm). This rule is codified at 21 CFR 101.91 and is a regulatory concentration limit — not a clinical eliciting dose. It applies to celiac disease management, not IgE wheat-allergy thresholds.
Official FDA resources
- FDA — Food Allergies (hub)Official FDA overview of major food allergen labeling, the FALCPA (2004) and FASTER Act (2021) framework, and enforcement.
- FDA — The FASTER Act: Sesame Is the Ninth Major Food AllergenAs of January 1, 2023, sesame must be declared on packaged foods and dietary supplements. FDA explains the addition of the 9th major allergen.
- FDA — Questions and Answers on the Gluten-Free Food Labeling Final RuleFDA final rule defining "gluten-free": unavoidable gluten must be less than 20 parts per million (ppm). Codified at 21 CFR 101.91.
- FDA — "Gluten-Free" Means What It Says (consumer update)Plain-language FDA consumer update explaining the <20 ppm gluten threshold and how it protects people with celiac disease.
| Allergen | ED01 (mg) | ED05 (mg) | ED10 (mg) | Additional Doses | Population Studied | Year | Source | Notes |
|---|---|---|---|---|---|---|---|---|
| Peanut | — | 2.00 | — | — | Pooled peanut-allergic patients from DBPCFC dose-distribution modelling used by the FAO/WHO Expert Consultation | 2022 | FAO/WHO FAO/WHO. 2022. Risk Assessment of Food Allergens — Part 2: Review and establish threshold levels in foods for the priority allergens. Meeting report of the ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens. Food Safety and Quality Series. Rome. (OpenKnowledge handle cc2946en) ✓ CitedView source | FAO/WHO Reference Dose (RfD) based on the ED05 (eliciting dose predicted to provoke a reaction in 5% of the allergic population). ED01/ED10 pending population from the underlying dose-distribution data. Thresholds are population estimates, not individual safe-exposure levels. |
| Hazelnut | — | 3.00 | — | — | Pooled hazelnut-allergic patients from DBPCFC dose-distribution modelling used by the FAO/WHO Expert Consultation | 2022 | FAO/WHO FAO/WHO. 2022. Risk Assessment of Food Allergens — Part 2: Review and establish threshold levels in foods for the priority allergens. Meeting report of the ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens. Food Safety and Quality Series. Rome. (OpenKnowledge handle cc2946en) ✓ CitedView source | FAO/WHO Reference Dose (RfD) based on the ED05. ED01/ED10 pending population from the underlying dose-distribution data. Thresholds are population estimates, not individual safe-exposure levels. |
| Soy | — | 10.00 | — | — | Pooled soy-allergic patients from DBPCFC dose-distribution modelling used by the FAO/WHO Expert Consultation | 2022 | FAO/WHO FAO/WHO. 2022. Risk Assessment of Food Allergens — Part 2: Review and establish threshold levels in foods for the priority allergens. Meeting report of the ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens. Food Safety and Quality Series. Rome. (OpenKnowledge handle cc2946en) ✓ CitedView source | FAO/WHO Reference Dose (RfD) based on the ED05. ED01/ED10 and VITAL 3.0 ED01 pending verification from the underlying dose-distribution publications. Thresholds are population estimates, not individual safe-exposure levels. |
| Hen's Egg | — | 2.00 | — | — | Pooled hen's-egg-allergic patients from DBPCFC dose-distribution modelling used by the FAO/WHO Expert Consultation | 2022 | FAO/WHO FAO/WHO. 2022. Risk Assessment of Food Allergens — Part 2: Review and establish threshold levels in foods for the priority allergens. Meeting report of the ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens. Food Safety and Quality Series. Rome. (OpenKnowledge handle cc2946en) ✓ CitedView source | FAO/WHO Reference Dose (RfD) based on the ED05. ED01/ED10 pending population from the underlying dose-distribution data. Thresholds are population estimates, not individual safe-exposure levels. |
| Cow's Milk | — | 2.00 | — | — | Pooled cow's-milk-allergic patients from DBPCFC dose-distribution modelling used by the FAO/WHO Expert Consultation | 2022 | FAO/WHO FAO/WHO. 2022. Risk Assessment of Food Allergens — Part 2: Review and establish threshold levels in foods for the priority allergens. Meeting report of the ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens. Food Safety and Quality Series. Rome. (OpenKnowledge handle cc2946en) ✓ CitedView source | FAO/WHO Reference Dose (RfD) based on the ED05. ED01/ED10 pending population from the underlying dose-distribution data. Thresholds are population estimates, not individual safe-exposure levels. |
| Wheat | — | 5.00 | — | — | Pooled wheat-allergic patients (IgE-mediated) from DBPCFC dose-distribution modelling used by the FAO/WHO Expert Consultation | 2022 | FAO/WHO FAO/WHO. 2022. Risk Assessment of Food Allergens — Part 2: Review and establish threshold levels in foods for the priority allergens. Meeting report of the ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens. Food Safety and Quality Series. Rome. (OpenKnowledge handle cc2946en) ✓ CitedView source | FAO/WHO Reference Dose (RfD) based on the ED05; later follow-up discussion proposed a separate gluten-based value (~4 mg). ED01/ED10 and VITAL 3.0 ED01 pending verification from the underlying dose-distribution publications. Thresholds are population estimates, not individual safe-exposure levels. |
| Sesame | — | 2.00 | — | — | Pooled sesame-allergic patients from DBPCFC dose-distribution modelling used by the FAO/WHO Expert Consultation | 2022 | FAO/WHO FAO/WHO. 2022. Risk Assessment of Food Allergens — Part 2: Review and establish threshold levels in foods for the priority allergens. Meeting report of the ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens. Food Safety and Quality Series. Rome. (OpenKnowledge handle cc2946en) ✓ CitedView source | FAO/WHO Reference Dose (RfD) based on the ED05. ED01/ED10 and VITAL 3.0 ED01 pending verification from the underlying dose-distribution publications. Thresholds are population estimates, not individual safe-exposure levels. |
| Hen's Egg | 0.200 | — | — | — | Pooled hen's-egg-allergic patients (adult & pediatric) from DBPCFC dose-distribution modelling | 2019 | VITAL® (Allergen Bureau) Allergen Bureau. VITAL® 3.0 Reference Doses and Action Level Grid (2019); Remington et al., Allergy (2020). ✓ CitedView source | VITAL 3.0 Reference Dose based on the ED01. ED05/ED10 pending population from the underlying dose-distribution publication. Thresholds are population estimates, not individual safe-exposure levels. |
| Peanut | 0.200 | — | — | — | Pooled peanut-allergic patients (adult & pediatric) from double-blind placebo-controlled food challenge (DBPCFC) dose-distribution modelling | 2019 | VITAL® (Allergen Bureau) Allergen Bureau. VITAL® 3.0 Reference Doses and Action Level Grid (2019); Remington et al., 'Updating the VITAL allergen risk analysis: the 2019 VITAL reference doses', Allergy (2020). ✓ CitedView source | VITAL 3.0 Reference Dose based on the ED01 (eliciting dose predicted to provoke a reaction in 1% of the allergic population). ED05/ED10 pending population from the underlying dose-distribution publication. Thresholds are population estimates, not individual safe-exposure levels. |
| Cow's Milk | 0.200 | — | — | — | Pooled cow's-milk-allergic patients (adult & pediatric) from DBPCFC dose-distribution modelling | 2019 | VITAL® (Allergen Bureau) Allergen Bureau. VITAL® 3.0 Reference Doses and Action Level Grid (2019); Remington et al., Allergy (2020). ✓ CitedView source | VITAL 3.0 Reference Dose based on the ED01. ED05/ED10 pending population from the underlying dose-distribution publication. Thresholds are population estimates, not individual safe-exposure levels. |
| Hazelnut | 0.100 | — | — | — | Pooled hazelnut-allergic patients from DBPCFC dose-distribution modelling | 2019 | VITAL® (Allergen Bureau) Allergen Bureau. VITAL® 3.0 Reference Doses and Action Level Grid (2019); Remington et al., Allergy (2020). ✓ CitedView source | VITAL 3.0 Reference Dose based on the ED01. ED05/ED10 pending population from the underlying dose-distribution publication. Thresholds are population estimates, not individual safe-exposure levels. |
Peanut
2022Population: Pooled peanut-allergic patients from DBPCFC dose-distribution modelling used by the FAO/WHO Expert Consultation
FAO/WHO Reference Dose (RfD) based on the ED05 (eliciting dose predicted to provoke a reaction in 5% of the allergic population). ED01/ED10 pending population from the underlying dose-distribution data. Thresholds are population estimates, not individual safe-exposure levels.
Hazelnut
2022Population: Pooled hazelnut-allergic patients from DBPCFC dose-distribution modelling used by the FAO/WHO Expert Consultation
FAO/WHO Reference Dose (RfD) based on the ED05. ED01/ED10 pending population from the underlying dose-distribution data. Thresholds are population estimates, not individual safe-exposure levels.
Soy
2022Population: Pooled soy-allergic patients from DBPCFC dose-distribution modelling used by the FAO/WHO Expert Consultation
FAO/WHO Reference Dose (RfD) based on the ED05. ED01/ED10 and VITAL 3.0 ED01 pending verification from the underlying dose-distribution publications. Thresholds are population estimates, not individual safe-exposure levels.
Hen's Egg
2022Population: Pooled hen's-egg-allergic patients from DBPCFC dose-distribution modelling used by the FAO/WHO Expert Consultation
FAO/WHO Reference Dose (RfD) based on the ED05. ED01/ED10 pending population from the underlying dose-distribution data. Thresholds are population estimates, not individual safe-exposure levels.
Cow's Milk
2022Population: Pooled cow's-milk-allergic patients from DBPCFC dose-distribution modelling used by the FAO/WHO Expert Consultation
FAO/WHO Reference Dose (RfD) based on the ED05. ED01/ED10 pending population from the underlying dose-distribution data. Thresholds are population estimates, not individual safe-exposure levels.
Wheat
2022Population: Pooled wheat-allergic patients (IgE-mediated) from DBPCFC dose-distribution modelling used by the FAO/WHO Expert Consultation
FAO/WHO Reference Dose (RfD) based on the ED05; later follow-up discussion proposed a separate gluten-based value (~4 mg). ED01/ED10 and VITAL 3.0 ED01 pending verification from the underlying dose-distribution publications. Thresholds are population estimates, not individual safe-exposure levels.
Sesame
2022Population: Pooled sesame-allergic patients from DBPCFC dose-distribution modelling used by the FAO/WHO Expert Consultation
FAO/WHO Reference Dose (RfD) based on the ED05. ED01/ED10 and VITAL 3.0 ED01 pending verification from the underlying dose-distribution publications. Thresholds are population estimates, not individual safe-exposure levels.
Hen's Egg
2019Population: Pooled hen's-egg-allergic patients (adult & pediatric) from DBPCFC dose-distribution modelling
VITAL 3.0 Reference Dose based on the ED01. ED05/ED10 pending population from the underlying dose-distribution publication. Thresholds are population estimates, not individual safe-exposure levels.
Peanut
2019Population: Pooled peanut-allergic patients (adult & pediatric) from double-blind placebo-controlled food challenge (DBPCFC) dose-distribution modelling
VITAL 3.0 Reference Dose based on the ED01 (eliciting dose predicted to provoke a reaction in 1% of the allergic population). ED05/ED10 pending population from the underlying dose-distribution publication. Thresholds are population estimates, not individual safe-exposure levels.
Cow's Milk
2019Population: Pooled cow's-milk-allergic patients (adult & pediatric) from DBPCFC dose-distribution modelling
VITAL 3.0 Reference Dose based on the ED01. ED05/ED10 pending population from the underlying dose-distribution publication. Thresholds are population estimates, not individual safe-exposure levels.
Hazelnut
2019Population: Pooled hazelnut-allergic patients from DBPCFC dose-distribution modelling
VITAL 3.0 Reference Dose based on the ED01. ED05/ED10 pending population from the underlying dose-distribution publication. Thresholds are population estimates, not individual safe-exposure levels.
This reference table is designed to grow as new data become available. Additional eliciting doses (ED05, ED10, and others), allergens, and sources — including future FAO/WHO recommendations, FDA guidance, ILSI Europe and EuroPrevall outputs, and peer-reviewed dose-distribution studies in journals such as JACI, Allergy, Clinical & Experimental Allergy, and The Journal of Food Protection — will be added as they are verified against the original publications.
About this data
Threshold values on this page are drawn from authoritative scientific and regulatory sources, including the VITAL® Program (Allergen Bureau), FAO/WHO Expert Consultations, ILSI Europe, EuroPrevall, NIH/NIAID, FDA, and FARRP. Every record lists its source organization, full citation, and a direct link to the original publication where available.
While we strive for accuracy, information may change over time. Always double-check and verify against official sources before relying on it.