Global Shifts in Precautionary Allergen Labelling: Embracing a Risk-Based Approach

By Beatrice Povolo  

Food labelling plays a vital role in today’s global marketplace, providing essential information that enables consumers to make informed choices and confidently navigate grocery store aisles. Accurate labelling allows consumers to align their health needs with their purchasing decisions and acts as a safeguard from inadvertent exposure to foods that may be harmful to them. No one relies on this information more than individuals living with food allergy – for them, the ingredient label is a crucial lifeline. 

The Increasing Impact of Food Allergies 

Over the past 20 years, there has been a significant growth in food allergy, with it now affecting as much as 10 percent of the global population. It substantially impacts an individual’s quality of life as it transforms something as basic as eating into a daily challenge that requires careful planning and vigilance. Consumers at risk rely on avoidance of their allergen(s) to prevent severe and potentially life-threatening allergic reactions (anaphylaxis).

By adopting a risk-based strategy guided by expert advice, manufacturers can ensure accurate labelling practices and help rebuild consumer confidence.

As a result, food allergy has become a growing food safety concern worldwide, prompting allergic consumers to seek transparency from the food industry on their allergen management practices, and reassurance in the accuracy of food labelling. As such, there is a growing interest in tackling one of the most significant labelling challenges faced by manufacturers and consumers:  precautionary allergen labeling (e.g. may contain statements). 

Precautionary Allergen Labelling Challenges 

Various jurisdictions globally have taken actions to enhance consumer protection for individuals living with food allergy. These efforts have focused on improving food labelling practices, particularly in the declaration of allergenic ingredients deliberately added to prepackaged food. However, the same cannot be said for the use of precautionary allergen labelling (PAL).

PAL was intended to be a risk communication tool to warn consumers against the potential unintended presence of a food allergen in a product. This type of labelling is permitted in many jurisdictions worldwide but, for the majority, is not specifically regulated by local authorities, including in the United States, Canada, Australia, UK, and many countries in the European Union. With this lack of regulation or specific guidance, overuse and misuse of PAL has occurred. This has resulted in the proliferation of PAL statements.   

For consumers with food allergies, the increased and inconsistent use of PAL has eroded their trust in this type of warning. Furthermore, this has led to reduced quality of life and higher levels of risk for allergic consumers who frequently disregard PAL. Recent studies have revealed instances where PAL has been applied despite no detectable levels of the allergen, while in other cases the amount of allergen present exceeded incidental cross-contact levels. These findings suggest that consumers may unnecessarily restrict their food choices, while others may take risks that could potentially lead to harmful consequences. 

For food manufacturers, the use of PAL is also difficult to navigate. Many acknowledge the importance of effective allergen management to mitigate consumer risk. However, without defined industry guidance or government regulation, manufacturers apply a variety of approaches when it comes to PAL.  This inconsistency confuses consumers and makes it difficult for them to assess the meaning of a PAL statement. Compounding this is the complex process of how to assess the risk of allergen cross-contact. Accurate and consistent allergen information from suppliers is crucial for PAL accuracy, yet, coordinating allergen information across complex supply chains and multiple suppliers adds logistical challenges. Small and medium-sized enterprises may also face challenges in the form of limited resources.  

Risk-Based Approach to PAL on the Horizon 

To improve allergen management practices and the effectiveness of PAL on a global scale, collaboration between the food industry, regulators, healthcare, academia, and consumer advocacy groups is key. This issue has attracted the attention of both domestic and international stakeholders, looking to both assist the food industry and support allergic consumers.  

New guidance is emerging from the recent work undertaken by the Codex Committee on Food Labelling (CCFL), informed by advice provided from an FAO/WHO Expert Consultation on Risk Assessment of Food Allergens.   

The CCFL is currently considering the following recommendations from the FAO/WHO expert group during their upcoming international meeting this fall: 

• Use of PAL: restricted to those situations in which the unintended presence of a food allergen(s) cannot be prevented or controlled using effective allergen management practices and may result in exposure above a set level (e.g., reference dose) 

• Decision to use PAL: based on the findings of a risk assessment of unintended allergen presence to determine exposure above a set reference dose  

• Use of allergen thresholds: threshold levels of allergenic protein in a food, based on reference doses, should determine the use of PAL. A reference dose is the amount of allergenic protein below which most allergic consumers would not experience a reaction. The use of thresholds for PAL based on reference doses that would protect 95 percent of the allergic population (“ED05”) has been recommended by the FAO/WHO Expert Group. See the full list of FAO/WHO allergen threshold recommendations here. 

Recommending the adoption of a risk-based approach, including the use of allergen thresholds, is a significant advancement toward a more consistent approach to PAL. 

“Implementing a consistent, scientifically grounded approach to PAL will greatly benefit the global food industry, said Samuel Godefroy, Professor of  Food Risk Analysis and Regulatory Policies at Université Laval. “By adopting a risk-based strategy guided by expert advice, manufacturers can ensure accurate labelling practices and help rebuild consumer confidence.”  

The Netherlands Leads the Way 

These expert recommendations have prompted immediate action by one international jurisdiction that implemented a new PAL policy January 1, 2024. The Netherlands’s Ministry of Health, Welfare and Sport passed legislation that requires food business operators to follow the proposed recommendations currently under consideration by the CCFL, namely the use of a robust risk assessment to inform PAL based on published reference doses.

In addition, the Netherlands’ policy requires that manufacturers provide proof of when PAL is needed, as well as when it is not; they must gather evidence to investigate if cross-contact and unintended allergen presence actually occurs. This represents a significant shift and a positive step forward in making PAL more meaningful for consumers with food allergy. To help manufacturers comply with the new policy by January 1, 2026, the Netherlands has also issued a guidance document. 

Moving Forward on PAL 

As we navigate the challenges that PAL poses, the importance of integrating robust, science-based risk management practices to inform the use of PAL is underscored. This approach will benefit consumers living with food allergy by providing greater confidence in the labelling practices they rely on, and will provide industry with the tools needed to implement consistent best practices.  

About the Author:
Beatrice Povolo is the Director of Food Safety and Regulatory Affairs at Food Allergy Canada. She oversees food safety initiatives, focusing on accurate ingredient labelling. Povolo has also been involved in international allergen management discussions as part of the Health Canada delegation for the CODEX Committee on Food Labelling, and has co-led a project to develop Allergen Management and Precautionary Allergen Labelling Guidelines for the Canadian food industry.