The End of “May Contain” Chaos? How New Standards are Redefining Allergen Risk Assessment

For years, Precautionary Allergen Labelling (PAL) has been a source of frustration for both manufacturers and consumers. Before 2021, “May contain” statements existed in a legal grey zone—often used inconsistently as a “safety net” for legal protection rather than a reflection of actual risk.

This lack of clear standards left allergic consumers with two dangerous options: disregarding labels as meaningless (risking anaphylaxis) or avoiding a vast range of safe products due to a total lack of transparency.

1. The Global Scientific Shift (2021–2023)

In response to this “trust gap,” the Codex Committee on Food Labelling (CCFL) tasked FAO/WHO experts with a formal scientific risk assessment. This work has fundamentally changed the landscape of allergen management:

• From Zero Tolerance to Reference Doses (RfDs): Experts established the ED05 (the dose at which only the most sensitive 5% of the allergic population might react). This moves the industry away from “analytical zero”—which is technically impossible—to “clinically insignificant risk.”
• Harmonized Analytical Methods: For the first time, there are global guidelines for testing these proteins and interpreting the data.
• Quantitative Risk Assessment (QRA): The trend is clear: PAL should be applied only if a rigorous, documented QRA demonstrates a genuine risk to the consumer.

2. Regional Implementation: Who is Leading the Way?

While the science is global, the legislation is currently being implemented at different speeds across Europe.

The Netherlands: The First National Mandate (2025–2026)

The Netherlands is the proactive leader in this space. New Dutch policy (with full enforcement by January 1, 2026) represents the first national law in the EU to mandate specific PAL rules:

• Mandatory Risk Assessment: PAL can only be used if a documented assessment proves an actual risk based on ED05.
• Standardized Phrasing: The law aims to eliminate vague wording like “may contain traces of,” favoring clear, standardized statements.
• Goal: To ensure PAL is a meaningful safety tool, not a substitute for poor cleaning practices.

Spain: AESAN’s Technical Guidelines

Spain’s food safety agency (AESAN) has published a non-mandatory but highly influential guideline (Procedimiento para la gestión del contacto cruzado).

• It promotes the use of Action Levels (AL) derived from the FAO/WHO work.
• It provides a framework for manufacturers to justify the presence (or absence) of PAL through quantitative data, providing a “gold standard” for auditors and inspectors.

The European Union: Harmonization by 2027

The European Commission is working to close the regulatory gap for the unintentional presence of allergens (cross-contamination) across all Member States.

• The Initiative: An Implementing Regulation is scheduled for adoption at the end of 2027.
• The Requirement: Once active, PAL will remain a voluntary statement but must be supported by a rigorous, documented risk assessment. FBOs will have to prove that PAL is not being used to cover up a lack of Good Manufacturing Practices (GMP).

3. Summary: What this means for Food Businesses

The transition from “qualitative” (guessing) to “quantitative” (measuring) allergen management is no longer optional. To stay compliant, businesses should:

1. Review Cleaning Validations: Can your cleaning processes meet the new mg/kg thresholds defined by ED05?
2. Update Risk Assessments: Move away from “Just in Case” labeling. Document the specific Reference Doses (RfDs) used for your facility.
3. Prepare for Transparency: Be ready to justify every “May Contain” statement on your packaging with analytical data.

How We Help

Navigating the shift to ED05 and quantitative risk assessment is complex. At Mérieux NutriSciences, our expert consultants provide:

• Quantitative Allergen Risk Assessments (including VITAL® 4.0 analysis).
• On-site Cleaning Validation and analytical testing.

Label Check Services to ensure your PAL statements meet the specific requirements of Dutch, Spanish, and upcoming EU laws.