New allergen legislation as of 1 January 2026: what's changed and how to prepare

Why this change? 

“The main reason for the new legislation is that consumers with a food allergy currently cannot fully rely on allergen information,” says Willemsen. “Warnings such as ‘may contain traces of …’ are often added to the label as a precaution. Many producers do this to cover themselves, even when the chance of cross-contamination is actually small. As a result, these kinds of warnings appear on a great many product labels. For the consumer, that's difficult: a warning no longer automatically says anything about the actual risk. You no longer know whether the warning is accurate or not.” 

The new legislation is intended to remove this uncertainty, by providing clear frameworks for when a warning may and may not be used. The new rules are laid down in the Precautionary Allergen Labelling Policy Rule (Dutch Ministry of Health, Welfare and Sport, April 2025) and are supported by the Cross-Contamination Allergens guideline (FNLI, CBL and NVWA, 2024). 

What changed as of 1 January 2026

Two fixed warning phrases

From 2026, only two phrases are permitted for allergens that may unintentionally occur in your product (from PAL: Precautionary Allergen Labelling). These are: 

1. “May contain"
2. “Not suitable for people with a … allergy” 

All other variants are prohibited, including the folllowing:

• “May contain traces of…” 
• “Produced in a factory where … is also processed” 
• “May cause allergic reactions in…” 

You may only use a warning, moreover, if you can substantiate the risk. 

Warnings are a last resort

“The new rules require that you first do everything possible to prevent an allergen, before resorting to a warning on the label. You may only use an allergen warning on your label once: 

• you have carried out a full risk assessment, such as QRA or VITAL; 
• you can demonstrate that you have applied all control measures to prevent allergens from ending up in your product; and 
• the calculated exposure to allergens is above the established threshold value. 

Without evidence, you may not place a warning on your label, not even as a precaution,” explains Willemsen. 

New (higher) reference values

“Based on patient data, new threshold values have been established,” says Willemsen. “These are, in many cases, higher than before. That means your product may contain more of an allergen before you need to place a warning on your label. For example, the threshold value for hazelnut goes from 0.01 mg/kg to 3 mg/kg, and for egg the threshold value goes from 0.0045 mg/kg to 2 mg/kg.” 

“The new standards are based on the ED05 approach: a scientific method that calculates how much allergen is needed before a maximum of 5% of the allergic population experiences mild symptoms. The legislation follows this scientifically substantiated risk approach.” 

What does this mean for your label?

"The new rules have quite a significant impact. Many labels will need to be revised, but you don't have to recall existing packaging; the new rules apply to products manufactured from 1 January onwards. Products manufactured before 1 January 2026 therefore do not need to be recalled," Willemsen says. 

What does this mean for your production process? 

“The biggest change isn't on the label, but in the factory. The key question becomes: have you done everything to prevent allergens?” Where exactly should you start? Our tips, listed below: 

• Cleaning plan. Ensure a validated and verifiable cleaning process between production runs. Its effectiveness must be demonstrable (preferably via ATP, swabs, or allergen-specific validations). If effective removal of allergens cannot be confirmed, a PAL warning may be unavoidable. 
• Production sequence (run order). Plan production from allergen-free to allergen-containing products, unless process or safety requirements make this impossible. A correct run order minimises cross-contamination. 
• Physical separation. Consider physical separation of spaces, zones or equipment for specific allergens. This also includes separate storage, colour coding, and material management. 
• Walking routes & logistics. Manage staff and raw material flows to prevent allergen carry-over. Think of specific walking routes, clear clothing/tool protocols, and controlled transport movements. 
• Supplier information. Request complete, up-to-date specifications for all raw materials and semi-finished products. Incomplete information means you cannot complete a risk analysis. Without relevant data, you cannot substantiate the PAL, which poses a compliance risk during NVWA inspections. 
• Staff training. Ensure all employees know and correctly apply the new working method, run order, cleaning requirements, allergen risks, and communication lines. Awareness is crucial within the PAL guideline. 
• Documentation & safeguarding. Update HACCP, hazard and risk assessment (GIRA), the allergen matrix (with new ED05 reference values), work instructions, supplier assessments and cleaning validations. Also update the production run planning and internal checks. Ensure risk assessments per product are complete and traceable. 

We regularly get the question: “Can't I just do an analysis to check whether allergens occur in my product?” Willemsen tells us: “Analyses can be useful as a spot check or verification, but a lab test alone is not sufficient to substantiate a PAL warning on your label. Traces can occur randomly: out of 30 negative tests, the 31st  can still turn out positive. The legal basis is always the risk analysis, in which you assume the worst-case scenario.”