Codex Alimentarius Commission guidance promotes a harmonised risk assessment approach to precautionary allergen labelling to improve consumer confidence and provide greater clarity for food businesses.
An estimated 4.3% of the global population are affected by food allergies with reactions ranging from mild symptoms to life-threatening anaphylaxis1.
While the labelling of intentionally added allergen ingredients is mandated in regulations, the procedure for “may contains” statements covering the unintentional presence of allergens varies widely and remains unregulated in many parts of the world.
As a result, it can be difficult for consumers to judge the actual level of risk and some may unnecessarily avoid foods that are safe or lose confidence in the warnings and simply ignore them.
The unintended presence of food allergens or cross-contamination can occur during food production, even when the allergen is not an ingredient. For example, a cereal bar without nuts produced on the same line as nut-containing products may still contain traces of nuts despite cleaning procedures.
Allergens may also be transferred during ingredient handling and storage and therefore precautionary allergen labelling (PAL), including statements such as “may contain”, is often used to alert consumers to potential residual risks.
However, guidance is needed to prevent unnecessary PAL by ensuring warnings are only used when the risk has been scientifically assessed and cannot be adequately controlled through good allergen management practices.
The new Codex guidance recommends a qualitative risk assessment which can be supplemented with a quantitative risk assessment of unintended food allergen presence.
Reference doses for individual allergens are also included in the guidance and serve as the basis for establishing action levels.
The intention is that PAL shall only be used when, following the application of appropriate measures, the unintended presence of a food allergen(s) is above the action level for the allergenic food based on the reference doses for IgE-mediated food allergy and for coeliac disease.
PAL should not be used when the unintended presence of a food allergen(s) is at or below the action level.
The guidance also includes other points of clarification as for example, how to label in the case where the unintentional source of the gluten cannot be verified by risk assessment and how and where the PAL should appear on label.
The guidelines were adopted as part of the 49th Session of the Codex Alimentarius Commission2, held in Geneva, Switzerland, from 6 to 10 July 2026 and will be included as an annex to CCFL’s General Standard for the Labelling of Pre-packaged Foods (CXS 1-1985)3.
The guidance complements existing Codex standards on allergen declaration and food allergen management, including the Code of Practice on Food Allergen Management for Food Business Operators (CXC 80-2020)4.
While Codex guidance is voluntary, it often serves as an internationally recognised benchmark that supports national legislation and assists international trade.
Currently the European Commission5 is considering the adoption of harmonised requirements for the use of voluntary PAL statements and the UK are also exploring options6.
Notes: Established by FAO and WHO, the Codex Alimentarius Commission develops international food standards, guidelines and codes of practice to protect consumer health and promote fair practices in the food trade.
