Allergen declaration: US, EU and Mexico rules compared
Which allergens each market requires, how they must be shown on the label, what precautionary statements mean, and how to generate the declaration from data instead of typing it.
この記事は英語とスペイン語で提供されています。
Allergen labeling is the area where a single missing word causes the most recalls. The lists differ by market, the presentation rules differ too, and a product sold in three countries needs all three right. Codex Alimentarius provides the base list most regulators start from.
The lists side by side
| Market | Regulation | Mandatory allergens |
|---|---|---|
| United States | FALCPA 2004 + FASTER Act 2021 | 9: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, sesame |
| European Union | Regulation (EU) 1169/2011, Annex II | 14: cereals containing gluten, crustaceans, eggs, fish, peanuts, soybeans, milk, nuts, celery, mustard, sesame, sulphites ≥ 10 mg/kg, lupin, molluscs |
| Mexico | NOM-051-SCFI/SSA1-2010 (2020 amendment) | Cereals containing gluten, crustaceans, eggs, fish, peanuts, soybeans, milk, tree nuts, sulphites ≥ 10 mg/kg — declared with "Contiene…" |
| Canada | Food and Drug Regulations, enhanced labelling 2012 | Priority allergens incl. mustard and sulphites; gluten sources named |
How each market wants it shown
- US: a "Contains" statement right after the ingredient list, or the allergen source in parentheses within it (e.g., "whey (milk)"). Species required for fish, crustacean shellfish and tree nuts. Font must be at least as large as the ingredient list.
- EU: allergens are emphasized inside the ingredient list with a typeface that clearly distinguishes them — bold, capitals or color. A separate "Contains" box is not permitted when there is an ingredient list. Minimum x-height of 1.2 mm applies to all mandatory text.
- Mexico: allergens declared in the ingredient list and/or with the legend "Contiene" followed by the allergen names, immediately after the ingredients; may be listed with the phrase "Puede contener" only for genuine cross-contact risk.
Precautionary allergen labeling ("may contain")
Advisory statements are voluntary in all three markets and must never substitute the mandatory declaration of an ingredient. Regulators increasingly expect them to reflect a documented risk assessment rather than a blanket disclaimer: the EU is working toward harmonized thresholds and the FDA has stated that "may contain" must be truthful and not misleading. Best practice is one standardized wording per language, controlled centrally, applied only where cross-contact is real.
Where errors actually come from
- A reformulation adds an ingredient (a new emulsifier with soy) and the label text is not regenerated.
- The same product exported to the EU keeps the US wording, missing mustard, celery or lupin emphasis.
- Bold emphasis lost when the design is converted between printer languages or exported as plain text.
- A translation error turning "tree nuts" into a generic word that does not name the species.
How EtikStudio handles this
Allergens live in the product master as structured data with a translation per market. The template composes the ingredient list and the "Contains" line from that data, applies bold emphasis to allergen terms automatically for EU labels, and a rule per market decides which list applies. Change the formulation once and every label in every language updates — with version history for the recall file you hope never to open.
本ガイドは情報提供を目的としており、法的助言ではありません。規制は変更されるため、印刷前に必ず最新の公式文書をご確認ください。