Allergen Threshold: Definition & Risk Assessment
Allergen Threshold
How much peanut is too much? It’s the question behind every “may contain” label ever printed — and it turns out there’s a scientific answer, or at least the beginnings of one.
Definition
An allergen threshold is the amount of an allergenic food below which most allergic people wouldn’t react. It’s expressed as a reference dose in milligrams of allergenic protein, and it’s what makes quantitative allergen risk assessment possible.
Key facts
- Thresholds come from clinical oral food-challenge data — real allergic volunteers, real doses — modeled to find the dose that would affect a small fraction (say 1% or 5%) of the allergic population. These are the ED01/ED05 values you’ll see cited.
- The VITAL program publishes practical reference doses (for example, 0.2 mg of peanut protein) that manufacturers use to decide whether a precautionary label is actually warranted.
- FAO/WHO expert consultations spent 2021–2023 reviewing reference doses for priority allergens to feed into Codex work on precautionary labeling.
- Important caveat: thresholds describe population risk. They don’t promise any individual won’t react — which is why no threshold makes an undeclared allergen “legal.”
Why it matters
“May contain” labels have multiplied until allergic consumers started ignoring them — which defeats the entire purpose. Thresholds are the way out of that trap: measure your actual cross-contact, do the math against the reference dose, and label only when the risk is real. It’s better for allergic consumers and more honest for everyone else. The alternative — slapping “may contain everything” on every pack — protects the manufacturer while abandoning the consumer.
Sources: VITAL program; FAO/WHO expert consultations.
Quick reference
| Concept | Meaning |
| Reference dose | mg of allergenic protein protecting most allergic consumers |
| ED01 / ED05 | Dose affecting 1% / 5% of the allergic population |
| VITAL | Industry program applying reference doses to labeling |
| Key source | FAO/WHO allergen risk assessment reports |