Differences in Allergen Labelling: European Union, United States and Canada - A Practical Overview for the Food Industry

Published: 19 November 2025 | Author: Tomasz Krawczyk

Have you noticed how food labels change depending on the market?

Lists of Major Allergens - Number and Scope

- United States: The Food Allergen Labeling and Consumer Protection Act of 2004 and the Food Allergy Safety, Treatment, Education, and Research Act of 2021 list 9 major allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, sesame. Gluten relates exclusively to wheat; sources such as barley or rye are not included.

- Canada: Food and Drug Regulations and Safe Food for Canadians Regulations specify approximately 11 priority allergens: eggs, milk, mustard, peanuts, crustaceans and molluscs, fish, sesame, soy, sulphites, tree nuts, wheat. Gluten sources (barley, rye, oats) are also covered. Labels must be bilingual (English-French).

- European Union: Regulation (EU) No 1169/2011 on the provision of food information to consumers defines 14 allergens: cereals containing gluten (wheat, rye, barley, oats), crustaceans, eggs, fish, peanuts, soybeans, milk, nuts, celery, mustard, sesame seeds, sulphur dioxide and sulphites, lupin, molluscs.

Key difference: The European Union applies the broadest list, while the United States limits its requirements to the most common allergens.

"Contains" Statement - Requirement or Option?

- United States: Mandatory for major allergens present (e.g., "Contains: milk"). Does not cover cross-contamination risk.

- Canada: Required for priority allergens and gluten sources (e.g., "Contains: barley, milk / Contient: orge, lait"). Always bilingual.

- European Union: No separate statement - allergens must be highlighted within the ingredient list (e.g., in bold).

Key difference: The USA and Canada use a separate statement, while the EU integrates the information into the ingredient list.

"May Contain" - Precautionary Allergen Labelling (PAL)

- United States: Voluntary, recommended for cross-contamination risk with major allergens (e.g., "May contain: eggs"). Does not cover gluten beyond wheat.

- Canada: Voluntary, but recommended for priority allergens and gluten (e.g., "May contain: barley / Peut contenir: orge"). Bilingual and based on risk assessment.

- European Union: Voluntary, but must be credible. Often in the form of "May contain traces of...".

Difference: Canada and the EU include gluten sources in this statement, while the USA limits it to major allergens.

Other Important Elements

- Gluten-free: A common threshold of below 20 ppm gluten, but the EU and Canada are stricter regarding gluten sources.

For exporting companies: Adapting labels is crucial to avoid product recalls from the market!

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