Should may contain labeling be used under the regulation?

January 6, 2026 •

3 min read

According to the Food Allergy Research and Education (FARE), over 33 million Americans have food allergies, with many relying on food labels to avoid potentially life-threatening reactions. This growing public health concern drives the critical question: should may contain labeling be used under the regulation to improve consistency and consumer confidence?

Quick Summary

Current precautionary allergen labeling ('may contain') is voluntary and inconsistent, causing confusion and uncertainty for food-allergic individuals. This voluntary system has led to calls for regulation based on scientific risk assessments to provide clearer, more reliable allergen warnings for consumers.

Key Points

Problem with Voluntary Labels: Inconsistent, varied wording leads to consumer confusion, anxiety, and the potential for dangerous risk-taking by allergic individuals.
Risk-Based Regulation: International bodies like the FAO and WHO advocate for a standardized, threshold-based approach to replace voluntary labels with scientifically backed warnings.
Enhancing Safety and Trust: A regulated system would provide more accurate, reliable information on actual allergen risk, boosting consumer confidence and safety.
Potential Challenges: Implementing a regulated system requires investment in standardized testing, robust allergen management controls, and global harmonization efforts.
Manufacturer Responsibility: Prioritizing robust allergen control plans and using precautionary labels only as a last resort is a best practice for food businesses.
Expanded Consumer Choices: Preventing manufacturers from over-labeling low-risk products could increase safe food options for people with food allergies.

The Current State of Voluntary 'May Contain' Labeling

'May contain' statements, also known as precautionary allergen labeling (PAL), are voluntary labels used by food manufacturers to indicate the potential, unintended presence of allergens through cross-contamination during production. The lack of regulation allows manufacturers to apply these warnings inconsistently, making it hard for consumers to assess the actual risk. This practice is sometimes influenced by a desire to reduce legal liability.

Inconsistency and Consumer Confusion

The voluntary nature of PAL results in varied wording and application, causing significant confusion for consumers with food allergies. Different phrases are used inconsistently, and consumers may misinterpret these variations as different risk levels. Research indicates that allergic individuals employ complex reasoning to interpret labels, sometimes disregarding warnings. This can lead to a 'boy who cried wolf' effect, where overuse of warnings makes them less effective and potentially dangerous. The consequence is not only restricted dietary choices and increased anxiety but also a decrease in the perceived value of the warnings.

The Case for Regulating 'May Contain' Statements

Proponents of regulation argue that standardized, risk-based labeling is essential for public health and consumer trust. International bodies like the FAO and WHO have highlighted issues with current PAL systems and advocate for a framework based on Quantitative Risk Assessment (QRA) to guide labeling decisions.

A risk-based system would use scientific data to determine if a label is needed based on a scientifically defined threshold for an allergen. This approach offers several benefits:

Enhanced Consumer Safety: Provides a more accurate representation of risk, enabling safer food choices.
Clearer Labels: Replaces inconsistent wording with standardized alerts.
Expanded Options: Reduces unnecessary labeling of low-risk products, potentially increasing food choices.
Increased Trust: An evidence-based system can rebuild confidence in allergen warnings.

Implementing a Regulated System: Challenges

Transitioning to a regulated, risk-based system presents challenges, including the costs of more stringent allergen testing and monitoring for businesses. Small and medium-sized enterprises (SMEs) may face particular difficulties. Harmonizing regulations internationally also poses a challenge for global manufacturers. However, the long-term benefits in safety and transparency are considered to outweigh these initial obstacles.

Comparison: Voluntary vs. Regulated Precautionary Labeling


Feature	Voluntary Labeling (Current)	Regulated, Risk-Based Labeling (Proposed)
Basis	Manufacturers' discretion, often driven by liability concerns.	Quantitative Risk Assessment (QRA) and scientific thresholds.
Consistency	Highly inconsistent wording and application.	Standardized language and clear criteria.
Consumer Interpretation	Confusing; often distrusted or ignored, leading to anxiety or risk-taking.	Reliable; provides clear information for informed decisions.
Dietary Impact	Overuse of labels can lead to unnecessarily restricted diets.	Prevents over-labeling, potentially expanding food options.
Incentive for Manufacturers	Focus on legal protection rather than genuine risk communication.	Strong incentive for robust allergen control and accurate communication.

Alternatives and Best Practices for Manufacturers

Manufacturers should prioritize effective allergen management controls before using precautionary statements. The Food Standards Agency offers guidance on best practices to reduce cross-contamination, such as:

Rigorous Cleaning: Implementing thorough cleaning procedures or using dedicated equipment.
Segregated Storage: Storing allergenic ingredients separately.
Dedicated Equipment: Using separate equipment for products with different allergens when possible.
Production Scheduling: Running non-allergenic products before those with allergens.
Supplier Communication: Tracking allergen information from suppliers.

PAL should be used as a last resort only after a risk assessment indicates an unavoidable risk.

Conclusion: A Clearer Path Forward

The current voluntary system for 'may contain' labeling is problematic due to its inconsistency, which fosters mistrust and can endanger individuals with allergies by diluting the impact of warnings. The global shift towards a risk-based regulatory framework, supported by organizations like the FAO and WHO, offers a promising alternative. A regulated system using scientific data and thresholds can provide clear, dependable allergen information, enabling consumers to make truly informed choices. Despite implementation challenges, the long-term benefits of improved public health and consumer confidence strongly support a mandatory, regulated approach to precautionary allergen labeling. More information can be found through resources like the Food Standards Agency guidance on PAL.

Frequently Asked Questions

A 'may contain' label, or precautionary allergen labeling (PAL), is a voluntary statement used by food manufacturers to indicate the unintentional presence of an allergen due to cross-contamination during production.

No, in many countries, 'may contain' statements are voluntary and are not mandated by food labeling laws. This lack of regulation is a key part of the current debate.

The confusion stems from the lack of a consistent standard for when and how to apply these labels. Different wording and frequent overuse make it difficult for allergy sufferers to gauge the actual level of risk, leading to mistrust or dismissal of the warnings.

A risk-based approach uses quantitative risk assessment (QRA) and established allergen thresholds to scientifically determine if a 'may contain' label is truly necessary. It moves away from the hazard-based method of applying labels for even the slightest possibility of contamination.

Regulation would provide clearer, more reliable information based on scientific evidence. This would reduce the anxiety and confusion caused by current labeling practices, allowing people to make genuinely informed and safer decisions about their food choices.

This effect occurs when a cautionary warning, like 'may contain,' is used so often and without a clear basis that consumers start to ignore it. This poses a significant risk, as the label may be ignored when a genuine danger actually exists.

Manufacturers can implement robust allergen control plans by segregating raw materials, using dedicated equipment, scheduling production to minimize cross-contact, and conducting thorough cleaning and validation procedures.

Some believe that manufacturers use these labels broadly to avoid legal liability should a consumer have an adverse reaction. This mindset can detract from the labels' primary purpose of informing consumers of a genuine risk.