Time to ACT-UP: Rethinking Precautionary Allergen Labelling

Food allergies are a growing public health concern worldwide, affecting millions of individuals and significantly impacting their quality of life. For those managing food allergies, the risk of accidental allergen exposure is a constant worry, often compounded by the inconsistent and unregulated use of Precautionary Allergen Labelling (PAL). This article explores the current challenges and proposed solutions for improving PAL, as detailed in the comprehensive review by Turner et al., published in the World Allergy Organization Journal.

The Problem with Current PAL Practices

Precautionary Allergen Labelling, often recognised through phrases such as “may contain” or “produced in a facility that also processes,” is intended to inform consumers about the unintended presence of allergens in food products. This unintended presence, or Unintended Allergen Presence (UAP), can occur due to cross-contact during various stages of food production, such as harvesting, storage, or manufacturing. Despite the widespread use of PAL, its application remains unregulated in many countries, resulting in inconsistency and confusion.

The World Allergy Organization (WAO) highlighted these issues in 2014, calling for an international framework to standardise PAL application. Yet, as of 2024, the problem persists, with many food businesses using PAL as a blanket measure to mitigate potential liability rather than to convey specific risk information to consumers. This has led to a scenario where PAL is often seen as a “safety net” rather than a meaningful risk communication tool.

Global Regulatory Efforts and Inconsistencies

Currently, about 100 countries have legislation requiring mandatory declaration of allergenic ingredients. However, few have regulations specifically addressing UAP. The Codex Alimentarius, a collection of internationally recognised food standards overseen by the FAO and WHO, has been adopted by many countries for allergen declaration. Still, the application of PAL varies widely.

For example, in the European Union, allergen declaration is required for 14 priority allergens, but PAL is not regulated, leading to inconsistent use across member states. In contrast, Japan has implemented specific thresholds for UAP, mandating that allergens present above 10 parts per million (ppm) must be declared, whether intentional or not. Switzerland has set similar action levels, but these differ from those in Japan, highlighting the lack of harmonisation even among countries with existing regulations.

Impact on Food-Allergic Individuals

For those living with food allergies, the inconsistent use of PAL can have a profound impact. The uncertainty over whether a product with PAL genuinely poses a risk leads many consumers to avoid such products altogether, limiting their food choices and increasing anxiety. Studies have shown that consumers often interpret different PAL statements as conveying different levels of risk, even when the actual risk may be the same. This confusion can lead to both over-avoidance, which restricts dietary variety, and under-avoidance, which increases the risk of accidental exposure.

Living with food allergies also imposes a financial burden, as shopping for safe foods can be more time-consuming and costly. This is particularly challenging for low-income families, exacerbating existing health inequalities. Moreover, the stress associated with managing food allergies can lead to social isolation, as affected individuals and their families may avoid social situations where food is present.

Evaluating the Effectiveness of PAL

Several studies have examined whether foods with PAL actually contain the allergens in question. The results are mixed. While many products with PAL do not contain detectable levels of the allergen, a small but significant number of products without PAL do, posing an unexpected risk to consumers. For instance, one study found that 32% of prepacked foods with PAL for peanuts actually contained peanuts, but so did 25% of those without any PAL.

This inconsistency is partly due to the nature of UAP. Particulate contamination, where allergen particles are not uniformly distributed, can lead to some batches being contaminated while others are not. This sporadic distribution makes it difficult to assess risk accurately and contributes to the perception that PAL is used indiscriminately.

Towards a Regulated Framework for PAL

The article advocates for a more regulated approach to PAL, grounded in risk-based assessments. The authors suggest using reference doses (RfDs) derived from eliciting doses (EDs), which are based on the amount of allergen expected to cause a reaction in a certain percentage of the allergic population. For example, an ED05 represents the dose that would trigger a reaction in 5% of allergic individuals.

By using RfDs informed by ED05, it is possible to establish a more accurate and consistent basis for when PAL should be applied. This approach would help to minimise unnecessary use of PAL while ensuring that products with a real risk of UAP are clearly labelled. The FAO/WHO Expert Consultation on food allergens has endorsed this approach, recommending its adoption in global food standards.

Addressing the Challenges Ahead

Despite the promise of a risk-based approach to PAL, several challenges remain. Achieving international consensus on a standardised framework is difficult due to differences in local legislation and consumer expectations. Additionally, there are concerns about how to protect the most sensitive individuals who may react to even very low levels of allergens.

One proposed solution is to use a two-tiered PAL system, where products with UAP below a certain threshold carry a specific label indicating that they are safe for 95% of allergic consumers. However, this approach has been met with resistance, as it could be seen as downplaying the risk to the most sensitive individuals.

The Way Forward

To move towards a more effective and trustworthy PAL system, it is essential to involve all stakeholders, including regulators, food businesses, and consumers. Education and awareness campaigns are needed to help consumers better understand PAL and make informed choices. For food businesses, clearer guidelines and a standardised risk assessment process would reduce the current over-reliance on PAL and improve consumer confidence.

In conclusion, the current use of PAL is inadequate and often misleading. A shift towards a regulated, risk-based approach is necessary to ensure that PAL serves its intended purpose: protecting the health and well-being of food-allergic individuals. As the FAO/WHO continues to work towards a global standard, it is hoped that future regulations will bring much-needed clarity and consistency to allergen labelling, making the world a safer place for those living with food allergies.

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