Allergen Declaration Compliance & Risk Management

From Mandatory Allergen Labeling to Quantitative Risk Assessment (QRA)

Allergen management is one of the most critical aspects of food safety and a leading cause of product recalls. Beyond listing ingredients, food businesses must comply with complex allergen regulation requirements related to cross-contact and precautionary statements. As regulatory expectations evolve, allergen labeling becomes increasingly challenging and requires careful review to help protect consumers and support compliance.

At Mérieux NutriSciences, we help you master allergen declarations through a combination of regulatory expertise, laboratory testing, and advanced Quantitative Risk Assessment (QRA).

Mandatory Allergen Labeling

In most jurisdictions, including the EU (Regulation 1169/2011) and the US (FASTER Act), highlighting major allergens is a legal requirement.

The “Big 14”: We ensure all mandatory allergens—from cereals containing gluten to mollusks—are correctly identified and emphasized (bold, italic, contrasting color or dedicated statements) in your ingredient list.
Terminology Audit: We verify that you are using the legally required names for allergenic ingredients to avoid consumer confusion and regulatory non-compliance.

Precautionary Allergen Labeling (PAL): The “May Contain” Dilemma

One of the greatest challenges for the food industry is managing the unintentional presence of allergens (cross-contact).

The End of “Cover-all” Labeling: Regulators are moving away from inconsistent “May contain” statements. In markets like the Netherlands, new laws require that PAL (Precautionary Allergen Labeling) only be used if a documented risk assessment proves an actual risk.
Threshold-Based Decisions: We help you move toward a Quantitative Risk Assessment (QRA). By using Reference Doses (such as ED05), determining if an allergen level is clinically significant, we help you avoid “over-labeling” while ensuring total consumer safety.

Our Integrated Approach for Allergen Declaration & Management

We provide a 360° solution to secure your allergen strategy:

Label Audit: Verification of ingredient lists and allergen highlighting.
On-Site Consulting: Auditing your production lines to identify cross-contact points.
Quantitative Risk Assessment: Applying VITAL® 4.0 standards to justify the use (or removal) of PAL statements.

Contact us and get support on your allergen declaration

Frequently Asked Questions (FAQ) | Mastering your Allergen Declaration

Specification Management