The European Commission has announced plans to introduce harmonised EU-wide rules for precautionary allergen labelling (PAL) - the "may contain" statements found on food packaging. An implementing regulation is expected to be adopted in the fourth quarter of 2027. This initiative, currently in the preparatory phase, aims to address a long-standing gap in EU food labelling law that has created confusion for consumers and inconsistent practices across markets.
Under current EU law, food manufacturers must clearly declare any of the 14 regulated allergens (such as nuts, milk, or gluten) that are intentionally used as ingredients. However, there are no harmonised rules for warning consumers about the unintentional presence of allergens that results, for example, from cross-contamination during manufacturing.
This regulatory gap has led to widespread but inconsistent use of precautionary statements such as "may contain traces of nuts" or "produced in a facility that handles milk". Without standardised EU-level guidance, food business operators sometimes apply these warnings broadly to minimise legal risk, even when the actual risk of allergen presence is minimal or has not been properly assessed. This practice can unnecessarily limit food choices for allergy sufferers who are left unable to distinguish between genuine risks and overly cautious labelling, but is also in breach of the guidance adopted by some Member States.
Several Member States have already begun addressing this gap at national level. The emerging consensus is that precautionary allergen labelling should only be used when preventive measures to avoid cross-contamination cannot be efficiently implemented and the product may genuinely present a risk to allergic consumers based on an appropriate risk assessment. Recent developments in countries such as the Netherlands and Spain provide valuable insight into the likely direction of the EU-level harmonisation.
Article 36 of Regulation (EU) No 1169/2011 on food information to consumers explicitly empowers the Commission to adopt implementing rules on voluntary information concerning the possible unintentional presence of allergens in food.
According to the Commission's 'Have Your Say' initiative, the implementing regulation is scheduled for adoption in Q4 2027, following a public consultation period expected to open in the coming months. Once adopted, the implementing regulation is expected to require food business operators to conduct rigorous, documented risk assessments before applying any precautionary allergen statement. Businesses will need to demonstrate that precautionary labelling is not being used as a substitute for proper preventive measures. Furthermore, they will be required to justify the use of PAL with quantitative data on allergen presence where cross-contamination risks cannot be eliminated.
The Commission is expected to publish a draft implementing regulation for public consultation in the coming months. Food industry stakeholders, consumer organisations and advocacy groups will have the opportunity to provide input to ensure the final regulation achieves an appropriate balance between consumer safety and practical feasibility.
This harmonisation represents a significant development in EU food labelling policy, addressing a gap that has persisted since 2011. Food business operators should begin preparing now by reviewing their current allergen management practices and precautionary labelling policies.