Allergen Labelling Rules: US vs EU Differences

Allergen labelling is one of the areas where companies most often assume their domestic approach will transfer cleanly to a new market, and it's also one of the areas where that assumption causes the most real problems. The underlying goal — telling consumers with allergies what's actually in a product — is shared across major markets, but the specific requirements for which allergens must be declared, how they must be declared, and what triggers a declaration obligation differ meaningfully between the US and EU in ways that aren't always obvious until a labelling review catches a gap.

Introduction to Food Labelling Compliance covers both frameworks in detail. Here's a look at where the real differences sit, and why they matter more than they might initially seem.

One of the more consequential differences is simply which substances are formally recognized as major allergens requiring declaration. The US recognizes a defined list of major food allergens under federal law. The EU's list of substances requiring allergen declaration is structured differently and includes some items not on the US list, and vice versa.

This matters directly for any product sold in both markets: a formulation that's fully compliant with US allergen declaration requirements can still be missing a required declaration under EU rules, or including an unnecessary one, simply because the two lists don't map onto each other exactly. Checking both lists independently, rather than assuming one covers the other, is a basic but commonly skipped step.

Beyond which substances require declaration, the US and EU differ in how that declaration must actually appear on a label. US requirements generally focus on allergen declaration either within the ingredient list itself or through a separate "contains" statement. EU requirements place strong emphasis on allergens being emphasized within the ingredient list itself, typically through specific formatting such as bold text or distinct typeface, rather than relying primarily on a separate statement.

This formatting difference is easy to overlook when adapting a label from one market to another, since it's not just about whether the information is present, but about the specific visual and structural way it needs to be presented.

Assuming a US-compliant label just needs translation for EU markets. Allergen declaration differences mean a literal translation of a US label can miss required EU-specific formatting or declaration requirements entirely, independent of the language itself.

Treating precautionary statement language as interchangeable. Given the differing regulatory expectations around precautionary statements, copying this language directly between a US and EU label without reviewing it against each market's specific guidance risks either overstating or understating actual cross-contamination risk in a way that doesn't meet either market's expectations well.

Not revisiting labels when formulations change. An allergen declaration that was accurate for an original formulation can become inaccurate after even a minor ingredient substitution, and the specific documentation and review process needed to catch this varies between regulatory systems, making this an easy gap to miss when managing products across multiple markets simultaneously.

Underestimating how differently "major allergen" is actually defined. Because both markets use broadly similar language — major allergens, priority allergens — it's easy to assume the underlying substance lists are more similar than they actually are, when in practice checking the specific lists independently for each market is a necessary step, not a formality.