News item from 28-10-2025
Q&A allergen policy published by NVWA
The NVWA has published a Q&A with the most frequently asked questions from the food industry about the Dutch allergen policy. The answers were developed in collaboration with the NVWA, FNLI, CBL, Allergenen Consultancy and have been reviewed by the Food Allergy Foundation, the Dutch Celiac Disease Association, ProVeg Netherlands, and the Ministry of Health, Welfare and Sport. The aim is to provide clarity on the implementation of the policy, labeling, and risk assessment regarding allergens and cross-contamination. The Q&A includes many questions and answers. The most important ones are listed below.
Implementation of the new policy
From January 1, 2026, all labels must comply with the new rulesThe starting point is the production date: products produced before January 1, 2026, may still be sold, provided they are safe.
Import, export and European harmonization
Dutch policy is aligned with European regulations and international developmentsMutual recognition applies to products from other Member States, where the PAL justification may differ. Dutch policy allows two types of wording to meet wording requirements in other countries. The principle of risk assessment using reference doses is not established in all countries. Exports to other EU countries are sometimes subject to other reference doses or action limitsAlthough no European country prescribes the use of ED01, this reference dose is still sometimes used internationally. Within the Codex Alimentarius, ED05 has been chosen as the starting point for the use of PAL. Discussions on this are well advanced.
Once this is finally established, broad harmonisation within Europe and beyond can be expected.
Wording and display of PAL
Only the terms "May contain xxx" or "Not suitable for xxx" are permitted. If "Not suitable for" is selected, the condition must be specified. For gluten-containing grains, this could be either celiac disease or, for example, wheat allergy. This wording can be confusing if only the cross-contamination allergens are listed and not the allergens that are also present as ingredients. Patient organizations therefore prefer "May contain."
A PAL label doesn't have to be in a different font, like "May contain PEANUTS." However, it's allowed.
A PAL should not be used if an allergen has been deliberately added; in that case, it must always be listed on the ingredients list.
For assortment packaging, ingredients and PAL may be combined, but labelling per component is preferred.
Allergen name in a PAL
Allergens must be listed in the ingredients list according to Annex II of Regulation (EU) No 1169/2011. This is a specific reference to the allergen. This also applies to the information in the PAL. For example: "May contain milk" if cross-contamination with whey powder is possible.
The Regulation specifically identifies the individual types of gluten-containing grains and nuts in a so-called "exhaustive list." Four types of grains are listed for gluten-containing grains (wheat, rye, barley, and oats), and eight for nuts. Other types of grains are not covered by the legislation.
The basic principle is that the named species must be specifically identified in the list of ingredients and therefore also in a PAL. There are some exceptions; see below. For the allergen groups crustaceans, fish, and mollusks, the specific species are not named in the Regulation. There are dozens of species, and there is no "exhaustive list." Therefore, in a PAL, the term crustacean, fish, or mollusk can be used, and the specific species need not be named.
Singular or plural can both be used: “May contain almonds” or “May contain almonds”.
Nuts
People with nut allergies often react to specific nuts, such as cashews and pistachios, or walnuts and pecans, while they tolerate other nuts. Therefore, it's important to distinguish between different types of nuts. In a PAL (Precautionary Allergen Labeling), the generic term "nuts" may be used if there is a demonstrable risk of cross-contamination with all legal nut types, despite preventive measures. For example, if "may contain nuts." If certain nuts are already listed as ingredients, "may contain other nuts" can be used.
Cross-contamination with all nut types doesn't necessarily have to occur simultaneously. For example, with varying production or raw materials, cross-contamination with a particular nut type can sometimes occur and sometimes not. It's important to prevent the PAL, and therefore the label, from changing too often on the same product.
Grains and gluten
Grains contain gluten and other proteins. For people with a specific grain allergy, such as a wheat allergy, the distinction between grains is important. Spelt is a type of wheat, so "may contain wheat" is sufficient. "Spelt" and "gluten" may be added, but not in place of "wheat." Therefore, in the case of cross-contamination with wheat or spelt, the following can be stated:
- “may contain wheat”
- “may contain wheat (gluten)”
But not: "may contain gluten." Gluten is not the allergen, but the grain that contains gluten. If the type of grain cannot be determined, "may contain gluten-containing grains" may be used. If gluten-containing grains are already listed as ingredients, "may contain other gluten-containing grains" may be used.
Raw material information and cross-contamination in the chain
Raw material suppliers or B2B suppliers can perform a risk assessment, but cannot verify the allergen content due to cross-contamination against safe limits. This requires insight into how their raw materials are used in end products. Furthermore, consumer product manufacturers may also experience additional cross-contamination in their processes. For a complete assessment of whether a PAL is required, both sources must be considered. To enable a quantitative assessment by manufacturers of consumer end products, provide suppliers with information about the amount of allergen at the next link in the chain.
For example, this can be done by allergen template being used.
Risk assessment: quantitative and qualitative
A risk assessment is required for each final product, taking into account both cross-contamination from raw materials and in the production process. validation of the cleaning forms an essential part of the process risk assessment. This assumes the worst-case scenario. This is not simply forgetting to clean, which is considered an incident. When selecting a product transition for validation, important considerations for this worst-case scenario are:
- Cleaning method: choose a transition after the mildest cleansing.
- Removability: Choose a product that is difficult to remove (e.g. sticky).
- Allergen protein content: Choose a product with the highest amount of allergenic protein.
The Q&A also describes alternative ways to easily perform a quantitative risk assessment, such as weighing particles found on the line after cleaning.
A qualitative risk assessment may be performed for artisanal products. In this case, no cross-contamination concentration is known, for example, from analysis, but only whether cross-contamination can or cannot occur. The steps of a qualitative risk assessment are the same as those of a quantitative risk assessment. There must also be evidence that cross-contamination actually occurs (see also below for production in the same space). Artisanal foods are prepackaged products that are delivered directly in small quantities to the end consumer or to local retailers, who supply directly to the end consumer.
Production in the same space
Processing different allergens in the same space is not automatically a reason to use a PAL. Airborne transmission rarely leads to food contamination at levels that pose a risk to allergy sufferers. The odor poses no risk to the products prepared there. Only in exceptional situations, such as high dust levels or the use of compressed air, can significant amounts of product particles be contaminated. The particle count then exceeds the ED05 limit.
It is important to differentiate between food allergy and inhalation allergy:
- Food allergies cause symptoms after eating an allergen. A visible amount of allergen is required for this to occur.
- Inhalant allergies cause symptoms after inhaling allergens. The amount required is much smaller than with oral exposure and can lead to respiratory problems such as hay fever or asthma. A common example is baker's asthma caused by wheat flour in the air.
Some allergens, such as egg powder, wheat flour, fish, and shellfish, can become airborne as microscopic particles (aerosols). These can cause symptoms in sensitive individuals when inhaled. However, if these particles land on other products, the quantity is too small to cause an oral reaction. Airborne allergens can pose a health risk for staff and visitors. Therefore, it is important to take preventive measures, such as good ventilation and avoiding compressed air near dusty products.
Scientific research shows that when processing wheat flour, a distance of 2 meters is sufficient to safely prepare gluten-free products in the same space.
Reference dose and concentration
The reference dose (ED05) is the basis for determining action limits. The reference doses are widely applicable and also cover vulnerable groups such as children. reference dose (RfD) is a fixed amount of allergen protein (in mg) per meal, and differs from a concentration (ppm = mg/kg product), also called an action limit. The action limit depends on the size of the meal and is therefore variable: for smaller meals, the concentration may be higher, and for larger meals, it must be lower.
For all European allergens from Annex II Regulation (EU) No 1169/2011 a separate reference dose has been established. These reference doses are in de Precautionary Allergen Labelling Policy Rule to find. For sulphites, the limit of 10 ppm stated in the Annex to the Regulation is maintained.
The ED05 of 5 mg for wheat applies to all grains containing gluten. However, a fixed limit of 20 ppm applies to gluten-free products. For consumptions up to 250 grams, the action limit for wheat is higher than 20 ppm. Therefore, the strictest limit is applied: if the calculated action limit is above 20 ppm, the gluten-free standard is still applied. And for higher consumptions, the action limit based on the ED05 is applied. This is called "truncating" the action limit to 20 ppm, and applies to each individual gluten-containing grain and to the total amount of gluten in the event of cross-contamination.
When is cross-contamination too high?
No upper limits have been established. A reference dose or action limit is a lower limit: if it is exceeded, a PAL is used. Higher concentrations of cross-contamination can occur even when preventive measures are taken. For example, in processes that are difficult to clean or in cases of point contamination.
However, an incident can also occur if, for example, cleaning has been overlooked. In such cases, concentrations of an allergen in a product of hundreds or even thousands of ppm can be present. This is considered an out-of-control situation for which a PAL is not appropriate. The reason for the higher values must therefore be determined and assessed on a case-by-case basis.
Enforcement and supervision
During inspections, the Netherlands Food and Consumer Product Safety Authority (NVWA) will assess whether PALs are being used correctly. To determine whether a PAL is being used for the right reasons, an assessment of the production process is required. A PAL without substantiation or in the absence of a risk is not permitted.
Products with excessive cross-contamination must be removed from the market and reported to the Netherlands Food and Consumer Product Safety Authority (NVWA). A cross-contaminated product is considered harmful if the allergen content exceeds the action limit and there is no warning (PAL) on the label.
The Dutch government can analyze consumer products marketed in the Netherlands but produced abroad. Foods without PAL that still contain too many allergens are considered harmful.
What should be done if the product is harmful?
When harmful products are identified, the Netherlands Food and Consumer Product Safety Authority (NVWA) must be notified. The harmful batches must be removed from the market, and the cause of the allergen's presence must be eliminated. An amended PAL can be added as a temporary exception only. In that case, foods that are no longer considered harmful due to this additional information may be sold. Re-labeling the entire label is always permitted.
If it proves impossible to eliminate the cause and keep cross-contamination below the action limit at all times, the label will have to be permanently adjusted.
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