May Contain: New Thinking on Allergen Risk

Food allergies have long been part of the food industry landscape, with allergen considerations shaping manufacturing, handling and consumption of food products on a global scale. The Food and Agriculture Organization of the United Nations (FAO) estimates about 220 million people worldwide live with food allergies. A 2019 study published in the American Medical Association’s JAMA Network Open estimated that about 10.8% of U.S. adults — more than 26 million people — have at least one convincing food allergy, and nearly 19% believe they have a food allergy.

Several factors deem allergen management a crucial aspect that food industry stakeholders need to consider; for example, there is no clear cure for food allergies, and responses such as anaphylactic shock can be fatal. Add to the mix the unpredictability of how food allergies develop and affect individuals over time, and allergen management becomes a critical part of risk management for food manufacturers.

Global approaches to allergen management have remained largely precautionary, often assuming any potential allergen presence poses a risk, even with the advent of new detection technologies and clinical data. In recent years, however, the FAO, in collaboration with the World Health Organization (WHO), conducted five joint expert consultations to examine a new, risk-based approach to allergen management.

Framework Goals.

Beginning in 2020, FAO and WHO convened a series of expert consultations on food allergen risk assessment, intended to update findings from a consultation in 1995. The resulting reports and guidance documents released between 2022 and 2025 form the foundation of a new risk-based framework for allergen management.

The FAO/WHO expert consultations outlined several goals for this framework, including:

1. Priority allergens. The FAO/WHO expert consultations evaluated priority allergens of global public health importance based on the risk posed by IgE-mediated allergic responses to high-risk foods. The group adopted a science-based approach, considering factors such as prevalence, potency and severity. Experts noted that alongside globally recognized allergens, some, like mustard or buckwheat, may be regionally significant and should be considered in allergen risk management frameworks.
2. Reference doses. The establishment of reference doses, or RfDs, was a key step in the new framework. RfDs are defined as milligram amounts of allergenic protein that “reflect a range of exposure without appreciable health risk.” Derived from dose-response data collected around the globe, these values represent exposure levels unlikely to cause allergic reactions in most allergic individuals.
3. Allergen labeling. Unintended allergen presence (UAP) — the unintentional contamination of food with allergens through cross-contact during manufacturing — poses a serious threat to individuals suffering from food allergies. To address this risk, manufacturers often use Precautionary Allergen Labeling (PAL), such as “may contain” statements, but declaration is voluntary. The new framework suggests using RfDs to help inform more risk-based decisions about when such labeling is warranted.
4. Highly processed products. Under traditional approaches to allergen management, highly processed products, such as soybean oil, may still carry allergen warning labels. The new framework suggests that reference doses could be used to determine whether such products can be exempted from allergen warning labels when the amount of allergenic protein present is unlikely to trigger reactions. “Allergen-free” claims were not studied during the formulation of the new framework.

In with the New.

The goals outlined above provide plenty for food manufacturers to consider. However, the question remains: Why is a new framework necessary? Put simply, accepted methods of allergen management have created challenges for manufacturers and consumers alike.

With the expansion of the global supply chain, a single product may be manufactured using ingredients sourced from multiple countries. As food products move across international markets, differing allergen labeling requirements can create compliance challenges for manufacturers, according to a 2025 study published in the journalAllergy, Asthma & Immunology Research. For example, New Zealand and Australia require a separate allergen summary statement in addition to allergen ingredient declarations. In Argentina, allergen declarations must appear on labels in Spanish.

International differences in labeling requirements and allergens of concern also pose risks to consumers. Variations in priority allergen lists and labeling practices can create confusion for individuals trying to avoid specific allergens, particularly when traveling across countries with different regulatory systems.

On the other end of the spectrum, different allergen management frameworks also could lead to overly cautious labeling, meaning consumers are unnecessarily shielded from food products that pose little to no risk. Because PAL is voluntary, inconsistent use can discourage allergic individuals from purchasing foods that may in fact be safe, reported the World Allergy Organization Journal.

What It Means for Manufacturing.

Allergen classification and labeling requirements affect the food manufacturing community at a global scale. Harmonizing a global allergen management framework could help simplify the system. But how would a food safety or a quality assurance manager at a small-to-medium-sized food or beverage company implement such a framework while adhering to local and regional requirements?

A good first step: Conduct a UAP risk assessment to evaluate where unintended allergen presence may occur in the manufacturing process and what changes may be needed once RfDs for allergenic proteins are considered. FAO and WHO also suggest that such risk assessments quantify potential allergenic contamination in units of milligrams of total protein from allergenic foods per kilogram of food analyzed to allow easier comparison with reference doses.

The new framework emphasizes the use of both qualitative and quantitative information. Risk assessments are expected to incorporate both types of data, recognizing that analytical results alone are not enough for a robust risk assessment.

To provide further guidance for food safety and quality assurance professionals, FAO and WHO released a video on YouTube, titled “A new method to manage food allergens — a risk-based approach,” summarizing the goals and key takeaways from the new framework and how it may influence daily manufacturing and handling practices.

What Comes Next.

One challenge in developing a harmonized international allergen framework is ensuring that regional differences in allergen prevalence and dietary patterns are still considered. While some allergens are globally recognized, others may pose greater risks in specific populations due to regional diets and food production practices.

Another key question to consider is whether the implementation of a new framework should be voluntary or enforced through legislation. Some countries, like Japan and Switzerland, have introduced strict legislation governing allergen declaration, while others take a voluntary approach. Determining how risk-based approaches should be incorporated into regulatory systems likely will remain an ongoing discussion.

Although a fully harmonized, internationally recognized allergen framework that effectively protects both consumers and manufacturers may still be several years away, the work of FAO and WHO is expected to inform future discussions with international bodies such as the Codex Alimentarius Commission, which requested the expert consultations to provide scientific advice on food allergen risk assessment.

The author is a freelance food safety and hygiene consultant, trainer, auditor and technical writer.