Allergen Labeling Requirements & Compliance
Allergen labeling requirements differ meaningfully by destination market in both which allergens must be declared and how the declaration must appear on packaging — a label compliant in one market is frequently non-compliant in another without relabeling, which makes this a genuine per-market compliance task rather than a one-time global standard.
The Major Allergen Lists Differ by Market
The US FDA requires declaration of nine major allergens (milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, sesame — sesame added in 2023); the EU requires declaration of fourteen allergens under EU Regulation 1169/2011, including some (like mustard, celery, and sulphites) not on the US list — a product compliant for US allergen labeling is not automatically compliant for EU import without checking the additional EU-specific allergens.
Precautionary Allergen Labeling ("May Contain")
"May contain" or "produced in a facility that also processes" statements are voluntary in most markets (not a legal requirement, but a risk-management practice) and are used inconsistently across suppliers — some apply it conservatively to any shared-facility risk, others use it sparingly, which means a buyer can't assume equivalent risk between two products just because neither carries a precautionary statement.
Format and Placement Requirements
Beyond which allergens must be declared, markets differ in how the declaration must be formatted — the EU requires allergens to be emphasized within the ingredient list itself (commonly bolded), while US requirements allow either an in-list emphasis or a separate "Contains" statement below the ingredient list — a label meeting one format convention doesn't automatically meet the other market's formatting rule even if the correct allergens are listed somewhere.
Verifying Compliance Before First Shipment
The practical compliance step is confirming, market by market, that the destination country's full allergen list is declared on the label in the required format — for private-label or reformulated products this needs re-verification each time the formulation changes, since a new ingredient can introduce a new allergen the existing label doesn't cover.
Consequences of Non-Compliant Allergen Labeling
Allergen labeling errors are among the most common causes of food recalls generally, and candy is not exempt — an undeclared allergen is a genuine safety issue (not just a technical violation) and the recall, liability, and reputational cost of an allergen-labeling failure is disproportionate to the cost of getting the label right before the first shipment.
FAQ
Frequently asked questions
Not automatically — the EU requires declaration of fourteen allergens under Regulation 1169/2011, several of which (mustard, celery, sulphites) aren't on the US FDA's nine-allergen list, so a US label needs review before EU market entry.
No, in most markets they're voluntary risk-management practice rather than a legal requirement, and suppliers apply them inconsistently — the absence of a precautionary statement doesn't guarantee equivalent cross-contact risk between two products.
Ready to get started?
Contact our team to discuss volumes, pricing, and supply structures for your market.