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Codex sets global thresholds for ‘may contain’ labels

Codex Alimentarius has adopted its first global guidance on when to use “may contain” allergen warnings, setting thresholds intended to stop the label being used as blanket legal cover.

The global food standards body, Codex Alimentarius Commission, approved the guidelines at its 49th session in Geneva, which took place between 6 and 10 July 2026, as an annex to the General Standard for the Labelling of Prepackaged Foods (CXS 1-1985).

At a glance:

• Codex adopted precautionary allergen labelling guidelines at its 49th session, which closed on 10 July 2026.
• Reference doses have been given for 21 allergenic foods, ranging from 1mg for almonds to 200mg for crustacea.
• The guidelines are voluntary. The thresholds would only take effect once nations write them into law.

Precautionary allergen labelling (PAL), which refers to the “may contain nuts” or “made in a factory that also handles milk” line on a pack, is unregulated in many parts of the world, and its use varies widely across products and countries according to the Food and Agriculture Organization of the United Nations (FAO).

“As a result, consumers often face inconsistent information that can make it difficult to judge the real level of risk,” the FAO added.

Of the global population, around 4.3% are affected by food allergies, and these warnings impact them in both directions.

“Some people unnecessarily avoid foods that are safe for them, while others may lose confidence in the warnings and choose to ignore them,” the FAO said.

The annex restricts precautionary labelling to situations where cross-contact “cannot be prevented or controlled” through the allergen management practises set out in the Codex code of practise for food business operators.

The FAO explained that the decision to apply a PAL warning “should be based on the findings of a risk assessment, which begins with qualitative risk assessment and may be supplemented with quantitative risk assessment”, and a warning is required only where unintended allergen presence is shown to sit above an action level derived from the reference doses.

The reverse obligation is also outlined in the annex: “PAL should not be used when unintended presence of a food allergen(s) is at or below the action level.”

Annex sets reference doses for 21 allergenic foods

The annex sets reference doses (milligrams of total protein) for 21 allergenic foods. A reference dose refers to the amount of allergen protein a person can eat without reacting.

The doses begin at 1mg for almond, Brazil nut, cashew, pistachio, macadamia, pine nut, walnut, pecan, celery, and mustard; 2mg for peanut, egg, milk, and sesame; 3mg for hazelnut; 5mg for wheat and fish; 10mg for buckwheat, lupin, and soy; and 200mg for crustacea.

Where a food has no reference dose, “regional/national competent authorities can establish a reference dose consistent with recognised principles”.

Converting a reference dose into an action level – the reference dose divided by the amount of product someone typically eats in a single sitting – shifts that number into a second measure: a limit in milligrams per kilogram of the food. Foods consumed in quantity, therefore, face stricter concentration limits.

Gluten is handled separately, and on a different basis. Coeliac disease is not an IgE-mediated allergy, which means it is not caused by IgE allergy antibodies. The annex gives it its own table and a single reference dose of 4mg of total gluten, which covers wheat, rye, barley, and related species including spelt and Khorasan.

No reference dose is set for oats: people with coeliac disease may react to oats through cross-contact with wheat, barley, or rye, rather than to oats themselves.

That separation has a direct impact on labelling. Where a gluten warning is necessary, the annex bars the term “gluten-free” from being claimed on pack. Manufacturers who cannot control gluten cross-contact below the action level are therefore not able to use the claim.

How ‘may contain’ must appear on pack

The guidance also changes the wording and position of the warning.

A PAL statement “shall commence with the words ‘May contain’ (or equivalent words such as ‘may be present’, as determined by the competent authorities)”, the annex reads.

It must be located in a separate statement directly under or close to the ingredient list and be as clearly presented as the allergen declaration itself.

Where gluten is present above the action level, but its source cannot be established by risk assessment, the three cereals – wheat, barley, and rye – must all be named.

The annex does not require end-product testing, and it sets no analytical methods.

The sequence it describes runs from allergen controls to qualitative risk assessment, with quantitative assessment as a supplement, as opposed to a starting point.

FoodDrinkEurope backs the text but wants clarity on gluten

“The Codex text is a significant step forward and reflects many elements FoodDrinkEurope has called for, notably a harmonised, science-based approach and ED05-based reference doses,” a spokesperson for FoodDrinkEurope, which represents the European food and drink industry and published its own position paper on precautionary labelling in 2024, told Ingredients Network.

“Some practical issues still require clarification, particularly regarding cereals containing gluten,” the spokesperson added.

Gluten was a question Codex referred back to scientists. Two FAO/WHO expert consultations took place in 2025 to settle the reference doses for gluten and cereals containing gluten. Once the outcomes of the consultations had been reported, the guidance was finalised in May 2026.

FoodDrinkEurope also rejected the premise that manufacturers currently label indiscriminately.

“We would not characterise current industry practice as ‘blanket’ labelling,” the spokesperson said, adding that many food business operators already apply allergen risk-assessment approaches, including quantitative risk assessment.

Regarding analysis, the spokesperson said: “systematic end-product testing is neither the objective nor the appropriate basis for PAL decisions.”

The annex agrees with this point. It requires a risk assessment that begins with qualitative methods and sets no testing requirement.

When precautionary allergen labelling rules become law

Codex standards are not binding.

They are the reference point that national and regional regulators draw on, and their adoption into local law determines compliance.

The European Union has faced growing calls to harmonise allergen labelling across member states. The Netherlands, for example, already has a national allergen policy applied from January 2024, with a two-year transition, which required all operators to comply by January 2026.

Asked how quickly the EU should turn the reference doses into binding rules, the FoodDrinkEurope spokesperson said: “Whilst we want it to be done in a timely fashion, the priority must be a framework that is clear, scientifically robust and practically feasible, developed with appropriate stakeholder consultation.”

Any new framework should also come with education for consumers, healthcare professionals, and food business operators, the spokesperson added.