World Health Organization (WHO) and the Food and Agriculture Organization of the United Nations (FAO) : the new 4 mg reference dose for gluten – InfoCons Consumer Protection informs you
In November 2025, the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) convened a major international expert consultation in Rome, Italy. The outcomes of this meeting represent a significant step forward in food safety policy, particularly for people worldwide living with coeliac disease.
The Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens introduced a scientifically grounded reference dose (RfD) of 4 mg of gluten for the application of precautionary allergen labelling (PAL). This recommendation marks a pivotal development in improving protection for consumers affected by gluten-related conditions.
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Understanding coeliac disease and gluten exposure
Coeliac disease is a long-term, immune-mediated condition affecting the intestine and other body systems in genetically susceptible individuals following exposure to gluten. Gluten proteins are found in wheat (including spelt and khorasan wheat), rye, barley, oats, their hybrid varieties, and derived products. Unlike IgE-mediated food allergies, which trigger immediate reactions, coeliac disease involves chronic exposure and cumulative harm.
Continued ingestion of gluten in affected individuals damages the intestinal lining and can lead to serious health consequences such as impaired nutrient absorption, osteoporosis, and a range of systemic complications. At present, the only effective treatment is strict, lifelong adherence to a gluten-free diet.
Maintaining such a diet is challenging due to the widespread presence of gluten in the food supply. Undeclared ingredients, cross-contact during production, and contamination throughout the supply chain all contribute to unintended gluten exposure. Ensuring access to safe, affordable, and clearly labelled food therefore remains a major concern for individuals with coeliac disease.
The expert consultation: scope and purpose
The consultation took place from 3 to 7 November 2025 at FAO headquarters and involved 14 experts from multiple scientific disciplines and regions of the world. The panel was chaired by Melanie Downs (University of Nebraska–Lincoln), with Jason Tye-Din (Walter and Eliza Hall Institute) acting as Rapporteur. Experts participated from countries including Spain, China, Italy, the Netherlands, Canada, Norway, Germany, Thailand, the United Kingdom, Australia, and the United States.
This meeting was convened in response to a formal request from the Codex Committee on Food Labelling (CCFL), which sought scientific advice on appropriate reference doses and concentrations for gluten and gluten-containing cereals. The work builds on a series of FAO/WHO expert consultations initiated in 2020 that systematically examined food allergen risk assessment.
The key outcome: a 4 mg gluten reference dose
The central conclusion of the expert panel was the establishment of a reference dose of 4 mg of gluten for assessing the risk of unintended gluten presence in foods. This value serves as a benchmark for determining when precautionary allergen labelling for cereals containing gluten should be applied.
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Scientific basis for the 4 mg threshold
Unlike IgE-mediated food allergies, where reactions can occur after a single exposure, coeliac disease requires consideration of long-term, cumulative intake. As a result, the panel adopted a risk assessment approach similar to that used in toxicology for chronic exposure.
The experts aimed to ensure that total daily gluten intake would not exceed 10 mg per day, a threshold rooted in existing Codex Alimentarius standards. Under the Codex definition of “gluten-free” (≤20 mg/kg), consumption of 500 g of food would result in a maximum intake of 10 mg of gluten per day.
This limit is supported by clinical evidence, including a double-blind, randomised controlled trial showing that daily consumption of 50 mg of gluten over three months caused intestinal damage in most participants, while effects at 10 mg were not statistically significant.
Modelling chronic gluten exposure
To determine an appropriate reference dose, the panel conducted detailed modelling exercises evaluating potential RfDs between 1 and 10 mg of gluten. These models were designed to reflect realistic, cumulative daily exposure rather than isolated eating events.
Key variables included:
- differing frequencies of unintended gluten presence;
- daily food consumption patterns across populations and countries;
- multiple food categories consumed throughout the day;
- varying gluten concentrations in foods;
- maximum concentrations allowed without PAL under a risk-based framework.
The modelling was intentionally conservative and grounded in peer-reviewed scientific data. Even when accounting for foods exceeding 20 mg/kg of gluten per eating occasion and lacking risk communication, predicted daily intakes rarely surpassed 10 mg.
While RfDs between 5 and 10 mg generally maintained exposures below the 10 mg daily threshold, the panel opted for 4 mg to provide an additional safety margin and avoid inconsistencies arising from multiple reference doses.
Updating the wheat protein reference
In addition to the gluten RfD, the experts recommended replacing the previously established 5 mg total wheat protein reference dose with the new 4 mg gluten-based value. This change harmonises guidance for both coeliac disease and IgE-mediated wheat allergy, offering clearer and more consistent consumer protection.
Impacts on food labelling and consumer protection
Adopting a 4 mg gluten RfD within a risk-based PAL framework has the potential to improve food safety, enhance consumer confidence, and provide greater regulatory clarity for food producers and authorities.
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Improved clarity and safety
Manufacturers will benefit from clear, science-based criteria for applying precautionary labelling, helping consumers better understand and trust food labels. The new approach also addresses the problematic coexistence of “gluten-free” claims and precautionary statements on the same product, which has historically caused confusion.
Reducing excessive precautionary statements
With a defined reference dose, manufacturers can move away from overly broad “may contain” warnings. Instead, PAL can be applied only when a genuine risk of exceeding the RfD exists, improving the usefulness of labels without compromising safety.
Practical and analytical challenges
The consultation identified several issues requiring attention during implementation:
Analytical limitations
- Current methods cannot differentiate between gluten sources (wheat, rye, barley);
- Robust performance criteria and improved reference materials are needed;
- Matrix effects may influence assay accuracy across food types;
- Greater transparency regarding assay reagents, particularly antibodies used in ELISA methods, is essential;
- Measurement uncertainty must be carefully considered near detection limits.
Communicating risk effectively
The panel highlighted scenarios that could lead to consumer misunderstanding:
- foods containing declared gluten cereals alongside cross-contact from other sources;
- the need to explicitly name “wheat” when PAL relates to wheat cross-contact, to protect individuals with IgE-mediated wheat allergy;
- products with large serving sizes that may meet gluten-free criteria by concentration but still exceed the 4 mg RfD per portion, potentially causing confusion and health risks.
Preventing such situations was strongly recommended.
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Responsibilities within food safety systems
Gluten and gluten-containing cereals should be managed through established food safety management systems, consistent with earlier FAO/WHO allergen guidance. Unintended gluten presence may arise from agricultural practices, manufacturing processes, or food preparation.
Food business operators are responsible for identifying and controlling these risks. Beyond labelling, the 4 mg RfD can support decisions related to recalls, compliance checks, and process improvements. Where exposure is measured as total protein, conversion to gluten equivalents is necessary for comparison with the RfD.
Broader FAO/WHO framework and future steps
This consultation concludes a multi-year FAO/WHO effort on food allergen risk assessment, following earlier reports published between 2022 and 2023 on priority allergens, thresholds, labelling, and exemptions.
The summary report released in November 2025 will support deliberations by Codex committees, with a full technical report to follow in the Food Safety and Quality Series. National authorities will now consider how to integrate these recommendations into domestic regulations, in consultation with industry, healthcare professionals, consumer groups, and coeliac disease organisations.
Food producers and standard-setting bodies will likewise need to update allergen management systems and labelling practices to align with the new gluten reference dose framework.
What is Gluten ?
Gluten is a family of elastic storage proteins, primarily gliadin and glutenin, found in grains like wheat, barley, and rye, acting as a binder that gives dough its stretchy quality, chewiness, and structure in baked goods like bread and pasta. While beneficial for most, it causes issues for people with celiac disease or gluten sensitivity, leading to health problems, though it’s also used as a texture enhancer and protein additive in many processed foods.
Where it’s found – InfoCons Informs You !
- Grains: Wheat (including spelt, durum, farro), barley, rye, and triticale (a wheat-rye hybrid).
- Common Foods: Breads, pastas, cereals, pastries, beer, crackers, and sauces (like soy sauce).
- Hidden Sources: Due to cross-contamination or additives, it can be in oats, processed meats, ice cream, and some seasonings.
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