Reference Doses (Thresholds) per Allergen: NL ED05, VITAL 3.0 and VITAL 4.0
Overview of all reference doses (thresholds) used in quantitative risk assessment (QRA) for precautionary allergen labelling (PAL). Values in mg allergenic protein.
Reference Doses per Standard
| Allergen | NL ED05 | VITAL 3.0 (ED01) | VITAL 4.0 (ED05) |
|---|---|---|---|
| Gluten-containing cereals | 5.0 | 0.7 | 5.0 |
| Crustaceans | 200.0 | 25.0 | 200.0 |
| Egg | 2.0 | 0.2 | 2.0 |
| Fish | 5.0 | 1.3 | 5.0 |
| Peanut | 2.0 | 0.2 | 2.0 |
| Soy | 10.0 | 0.5 | 10.0 |
| Milk | 2.0 | 0.2 | 2.0 |
| Almond | 1.0 | 0.1 | 1.0 |
| Hazelnut | 3.0 | 0.1 | 3.0 |
| Walnut | 1.0 | 0.03 | 1.0 |
| Cashew | 1.0 | 0.05 | 1.0 |
| Pecan | 1.0 | 0.03 | 1.0 |
| Brazil nut | 1.0 | 0.1 | 1.0 |
| Pistachio | 1.0 | 0.05 | 1.0 |
| Macadamia | 1.0 | 0.1 | 1.0 |
| Celery | 1.0 | 0.05 | 1.0 |
| Mustard | 0.4 | 0.05 | 1.0 |
| Sesame | 2.0 | 0.1 | 2.0 |
| Lupin | 15.0 | 2.6 | 10.0 |
| Molluscs | 20.0 | 25.0 | 20.0 |
What Do These Values Mean?
The reference dose is the amount of allergenic protein (in mg) that serves as the safe threshold. When calculated exposure through cross-contamination exceeds this threshold, precautionary allergen labelling (PAL) is required.
The action level (in mg/kg product) is calculated by dividing the reference dose by the consumption size in kg:
Action level = reference dose / consumption size in kg
Example: for peanut (reference dose 2.0 mg) with a consumption size of 100 g, the action level is 2.0 / 0.1 = 20 mg peanut protein per kg product.
Differences Between Standards
NL ED05 is the Dutch standard based on the Staatscourant 2025-14337. It uses ED05 values and an additional action level cap of 20 mg/kg for gluten-containing cereals.
VITAL 3.0 uses ED01 values (the dose at which 1% of the allergic population reacts). These are significantly lower thresholds, leading to more PAL requirements. Relevant for export to markets that follow VITAL 3.0.
VITAL 4.0 uses ED05 values (5% of the population) and is largely comparable to NL ED05. Small differences exist for mustard (0.4 vs 1.0 mg) and lupin (15.0 vs 10.0 mg). Published by the Allergen Bureau.
How Does Eclarion Use These Values?
Eclarion uses these reference doses automatically in the PAL assessment. You don't need to enter them manually. Per allergen, Eclarion calculates the Hazard Quotient (HQ) for all three standards simultaneously.