New Codex Guidelines for PAL: From “May Contain” to Demonstrably Risk-Based Allergen Management

10 November 2026

Precautionary Allergen Labeling (PAL), better known as warnings such as “may contain,” is on the verge of a fundamental change. In July 2026, the Codex Alimentarius Commission approved new international guidelines that link PAL to a scientifically based risk assessment. This means that a general precautionary warning is becoming increasingly difficult to justify under this Codex approach. The question is shifting from “Could cross-contamination occur?” to “What level of exposure could actually occur, how does it compare to a reference dose, and what control measures have been demonstrably implemented?”

Why Codex is taking action regarding the use of “may contain”

PAL is intended to warn consumers when an allergen may be unintentionally present in a product, for example due to shared production lines, storage, transportation, or handling. In practice, however, warnings are not applied consistently across the board. This can lead to consumers with allergies unnecessarily avoiding products, or conversely, ignoring warnings because they are not sufficiently distinctive. Codex aims to restore that breach of trust by allowing the use of PAL only when a residual risk has actually been identified after proper allergen control measures have been implemented.

The essence of the new guideline: control first, then assess, and only then label

The new provisions have been added as an annex to the General Standard for the Labeling of Pre-packaged Foods, CXS 1-1985. The basic principle is clear: PAL must not be a substitute for good manufacturing practices or effective allergen management. A company must first take reasonable and feasible measures to prevent or minimize cross-contamination. Only if unintentional presence is still possible after that should a qualified risk assessment be conducted. The outcome of that assessment determines whether a warning is necessary.

This transforms PAL from a generic disclaimer into the final step of a demonstrably controlled process. For QA, this requires a coherent rationale in which supplier information, recipes, process flows, cleaning, changeovers, reuse, dust dispersion, rework, storage, and transport are linked to realistic consumption data and the potential concentration of the allergen in the final product. Furthermore, the assessment must be revised whenever raw materials, suppliers, recipes, equipment, line layout, cleaning procedures, or packaging information change.

An employee wearing protective clothing uses a tablet for inspection and quality control at a production facility with stainless steel storage tanks.

Reference doses make the assessment quantitative

A key innovation is the use of scientifically derived reference doses. These doses are expressed in milligrams of total protein from the allergenic source and represent an exposure level that poses no significant health risk to the vast majority of the allergic population. The joint FAO/WHO expert consultations recommend, among other things, 1.0 mg for walnuts, pecans, cashews, pistachios, and almonds; 2.0 mg for eggs, milk, peanuts, and sesame; 3.0 mg for hazelnuts; 5.0 mg for fish and wheat; and 200 mg for shellfish. Additional values or risk management values have been established for soy, celery, mustard, and lupine, among others.

In practice, the reference dose is not the same as a fixed concentration limit in mg/kg. The relevant concentration depends on the amount of product expected to be consumed during a single meal. This means that portion size, analytical method, sampling, and variability in cross-contact are decisive factors in the quality of the conclusion. Furthermore, a reference dose is not intended to support a claim such as “allergen-free.”

What are the legal implications for food companies in the EU?

The Codex Guidelines are an international standard and do not automatically become directly applicable EU law. In the European Union, Regulation (EU) No. 1169/2011 remains the legal framework for food information. The fourteen allergens designated in the EU must be clearly listed when used as ingredients. A warning may be used in cases of unintentional presence, but according to the European Commission, it must be based on a thorough risk assessment and must not replace good manufacturing practices.

Nevertheless, the new Codex approach is directly relevant to European QA teams. Codex texts serve as an international reference point and can influence future legislation, oversight, trade conditions, customer requirements, and private standards. The European Union and its member states have actively participated in the development of the PAL guidelines. Furthermore, companies that supply internationally will encounter markets and customers that may incorporate the Codex methodology into their requirements more quickly.

From Label Verification to a Robust Decision-Making Dossier

For QA managers, the biggest challenge lies not in adjusting a single sentence on the label, but in demonstrably linking control, data, and decision-making. A strong PAL dossier demonstrates where unintended contamination can occur, what preventive measures have been implemented, what assumptions and data underpin the exposure calculation, and why the chosen warning is or is not necessary. Laboratory results can support that dossier, but a single negative analysis does not prove that cross-contamination is structurally absent. The rationale must be consistent with the process, the distribution of contamination, and the performance of the analytical method used.

Now is the time to reassess your PAL approach

There’s no need to wait for further European harmonization to start working more effectively right now. Verify that existing “may contain” warnings are based on a documented, product-specific risk assessment. Assess whether the selected consumption levels, analytical methods, and data on cross-contact are still up to date. Establish responsibilities for reassessment in the event of changes and ensure that R&D, procurement, production, labeling, and supplier management operate according to the same decision-making logic. This way, you not only prepare your organization for potential future requirements but also improve the reliability of allergen information and consumer confidence today.

Sources

FAO/WHO, Ad hoc Joint Expert Consultation on Risk Assessment of Food Allergens – Guidance for risk assessment: Summary and Conclusions, 2025.

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