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Resources  /  Knowledge Base  /  HACCP & Hazard Controls  /  Current Article

Allergen Threshold: Definition & Risk Assessment

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

ConceptMeaning
Reference dosemg of allergenic protein protecting most allergic consumers
ED01 / ED05Dose affecting 1% / 5% of the allergic population
VITALIndustry program applying reference doses to labeling
Key sourceFAO/WHO allergen risk assessment reports