Threshold values for allergens
Threshold values can be used to estimate the risks of cross-contamination with allergens. Also when testing results of analyses threshold values are very useful. However, threshold values are NOT ALLOWED used to determine whether an ingredient should be included in the ingredient declaration. After all, there is a zero limit for this, except for sulphite.
Cross-contamination
The "may contain" statement (Precautionary Allergen Labelling (PAL)) is NOT ALLOWED regulated by European regulations. Only the 14 allergens used as ingredients must be listed on the packaging. Unintended presence is considered voluntary food information under Regulation (EU) No. 1169/2011. Various European member states have therefore established their own guidelines and regulations. The Netherlands is one of them. As of January 1, 2026, the use of PAL be substantiated by a risk assessment based on reference doses.
This warning should only be used if cross-contamination occurs in quantities that pose a risk and it is impossible to prevent this cross-contamination. Precautionary measures should always be taken, wherever possible, such as recipe management, cleaning, proper layout of rooms and equipment, and rework procedures.
Some other European countries have also developed guidelines for labeling cross-contamination. Several countries outside Europe also have their own regulations. See the overview of legislation on cross-contamination and PAL for more information.
Reference dose
A reference dose (RfD) is the absolute amount of allergenic protein (mg) that has been deemed safe for people with an allergy. A specific limit has been established for each allergen. Sulfites are not proteins and cause different reactions (especially in people with asthma). Therefore, no reference dose has been established for sulfites, but a concentration of 10 ppm applies. This is used for listing in the ingredients list and can also be used for a PAL.
The reference dose is milligrams of protein of an allergenic product and is therefore no concentration in mg/kg (ppm).
To convert a reference dose to concentration (mg protein of an allergen / kg product = ppm) the RfD must be divided by the consumption size:
Action limit (mg/kg) = Reference dose (mg) / consumption size (kilo product per meal)
This means that the safe concentration (ppm) depends on the amount consumed of a product. The higher the consumption, the lower the safe concentration.
The safe concentration in the product is called an action level or action limit. If the allergen concentration remains below this limit, no cross-contamination warning is displayed on the label. If the action limit is exceeded, a warning is displayed, namely "may contain."
The reference doses (RfD) in the Netherlands, Belgium, and Germany are based on the recommended values by FAO/WHO (ED05). This choice is supported by patient organizationsIt is also expected that these values will be harmonized at international level in the foreseeable future through Codex Alimentarius.
Threshold values in EU countries
(see subscription for other countries)
| Allergen/Reference Dose |
FAO / WHO |
VITAL 4.1 | The Netherlands | Belgium | Germany | Czech Republic | |
|---|---|---|---|---|---|---|---|
| Unit mg allergenic protein (not ppm*), unless otherwise stated | ED05 | ED05 | ED05 | ED05 | ED05 | ppm calculated based on RfD and 100g consumption | ppm allergenic protein (fixed limit) |
| Nuts | |||||||
| cashew | 1,0 | 1,0 | 1,0 | 1,0 | 1,0 | 10 ppm | 2,5 ppm |
| almond | 1,0 | 1,0 | 1,0 | 1,0 | 1,0 | 10 ppm | 2,5 ppm |
| walnut | 1,0 | 1,0 | 1,0 | 1,0 | 1,0 | 10 ppm | 2,4 ppm |
| pecan | 1,0 | 1,0 | 1,0 | 1,0 | 1,0 | 10 ppm | - |
| pistachio | 1,0 | 1,0 | 1,0 | 1,0 | 1,0 | 10 ppm | 1,0 ppm |
| Brazil nuts | 1,0 | 1,0 | 1,0 | 1,0 | 1,0 | 10 ppm | - |
| macadamia nuts | 1,0 | 1,0 | 1,0 | 1,0 | 1,0 | 10 ppm | - |
| hazelnut | 3,0 | 3,0 | 3,0 | 3,0 | 3,0 | 30 ppm | 2,5 ppm |
| Celery | 1,0 | 1,0 | 1,0 | 1,0 | 1,0 | 10 ppm | 1,0 ppm |
| Ei | 2,0 | 2,0 | 2,0 | 2,0 | 2,0 | 20 ppm | 2,5 ppm |
| Fish | 5,0 | 5,0 | 5,0 | 5,0 | 5,0 | 50 ppm | - |
| Peanut | 2,0 | 2,0 | 2,0 | 2,0 | 2,0 | 20 ppm | 2,5 ppm |
| Lupine | 10 | 10 | 15 | 10 | 10 | 100 ppm | 1,0 ppm |
| Milk | 2,0 | 2,0 | 2,0 | 2,0 | 2,0 | 20 ppm | 2,5 ppm |
| Mustard | 1,0 | 1,0 | 0,4 | 1,0 | 1,0 | 10 ppm | 1,0 ppm |
| Sesame | 2,0 | 2,0 | 2,0 | 2,0 | 2,0 | 20 ppm | 2,5 ppm |
| Crusteaceans | 200 | 200 | 200 | 200 | 200 |
250 ppm |
- |
| Soybean | 10 | 10 | 10 | 10 | 10 | 100 ppm | 2,5 ppm |
| Gluten-containing grains/Wheat |
5,0 (wheat only) 4,0 (gluten total for wheat, rye and barley) |
5,0 for all grains and maximum action limit 20 mg gluten/kg ** |
5,0 for all grains and maximum action limit 20 mg gluten/kg ** |
5,0 |
5,0 |
50 ppm (gluten based) |
20 ppm (gluten based) |
| Molluscs | - | 20 | 20 | 200 | - | - | - |
The deviations from the FAO/WHO advice are shown in red. This advice is included in the Codex Committee for Food Labelling (page 52-53) discussed.
* A reference dose is measured in mg. Converting to ppm (mg per kilogram) is done using the formula:
Action limit (mg/kg) = Reference dose (mg) / consumption size (kilo product per meal)
** cut off to 20 ppm, see explanation in Q&A document NVWA
View full overview of legislation
cross-contamination allergens