Food Allergen Declarations: What FDA and CFIA Actually Require on Your Label

There is a mistake on a lot of labels printed before 2023: they declare eight major food allergens instead of nine. Sesame became the ninth major allergen under US law on January 1, 2023, added by the Food Allergy Safety, Treatment, Education, and Research Act (the FASTER Act), signed in April 2021. If your label was built before that date and has never been reviewed, there is a real possibility it is non-compliant right now.

That is one category of allergen problem. There are others. Founders selling into both the US and Canadian markets often discover that what FDA requires and what Health Canada requires are not the same list. A label that correctly declares all nine US major allergens can still be missing a required Canadian declaration. Products with shellfish face different rules north of the border. Mustard is regulated in Canada in ways it is not in the US. Sulphites require declaration in Canada that is separate from anything FDA mandates.

Here is what each framework actually requires, and where the two systems part ways.

The Nine US Major Food Allergens

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) established the original eight major food allergens under section 201(qq) of the Federal Food, Drug, and Cosmetic Act:

1. Milk
2. Eggs
3. Fish
4. Crustacean shellfish
5. Tree nuts
6. Peanuts
7. Wheat
8. Soybeans

The FASTER Act added sesame as the ninth, effective January 1, 2023. All FDA labeling requirements that apply to the original eight apply to sesame as of that date. Products on retail shelves before January 1, 2023 were not required to be removed or relabeled, but any label going to print after that date must include sesame in the allergen declaration if sesame is present.

If your product contains tahini, sesame oil, sesame seeds, or any ingredient derived from sesame, and your label predates 2023, it needs to be reviewed.

The Two Ways to Declare Allergens on a US Label

Under section 403(w)(1) of the FD&C Act, every major food allergen used as an ingredient must be declared on the label by its food source name. There are two accepted methods for doing this, and you can use one or both on the same label.

Method one: parenthetical declaration in the ingredient list. The allergen source name appears in parentheses immediately after the ingredient name. For example, “enriched flour (wheat),” “lecithin (soy),” or “whey (milk).” This is the most common approach and works well for products where the allergen name and ingredient name are different.

Method two: a “Contains” statement. A separate statement appears immediately after or adjacent to the ingredient list, beginning with the word “Contains” and listing all major allergen sources present in the product. For example: “Contains: Wheat, Milk, Soy, and Tree Nuts (Cashews).” This statement must be printed in type no smaller than the font size used for the ingredient list itself.

A critical rule: if you use a “Contains” statement, it must include all major food allergens in the product. A “Contains” statement that lists wheat and milk but omits soy would render the label misbranded, even if soy appears correctly in the ingredient list. The statement is all-or-nothing.

You may use both methods simultaneously. Many manufacturers use parenthetical declarations in the ingredient list and a “Contains” statement, because the latter is more immediately visible to consumers scanning a label quickly. Both are permissible under FDA guidance (Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling, Edition 5, released January 2025).

Three Categories That Require Specific Names

For tree nuts, fish, and crustacean shellfish, a broad category name is not enough. You cannot declare “Contains: Fish” or list “tree nuts” without specifying which one.

For tree nuts, you must name the specific nut: almonds, cashews, walnuts, pecans, hazelnuts, Brazil nuts, macadamia nuts, pine nuts, pistachios, or whichever types are present. A product containing both cashews and almonds needs both declared.

For fish, you must name the species: salmon, tuna, cod, halibut, anchovies, and so on. The same applies to crustacean shellfish: crab, lobster, shrimp, and related species must be named. A “Contains: Fish” statement without the species name does not satisfy the requirement.

Note that mollusks (clams, oysters, scallops, mussels) are not included in FDA’s definition of crustacean shellfish and are not a major food allergen under US law. If your product contains mollusks, you are not currently required to declare them as major allergens on a US label, though many manufacturers do voluntarily.

What Canada Requires: A Longer List

Canada’s priority food allergens are governed by the Food and Drug Regulations (FDR), specifically sections B.01.010.1 through B.01.010.3. The list of priority allergens is broader than the FDA’s.

Canada’s current list of priority food allergens includes:

1. Peanuts
2. Tree nuts (almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios, walnuts)
3. Sesame seeds
4. Milk
5. Eggs
6. Fish
7. Crustaceans
8. Molluscs (not required in the US)
9. Soy
10. Wheat or triticale
11. Mustard (not required in the US)

Beyond the allergen list itself, Canada also requires declaration of gluten sources (wheat, barley, rye, oats, and triticale) by their specific grain name. And added sulphites at 10 parts per million or more must be declared, a category that has no equivalent in FDA’s major allergen framework.

The practical differences matter most for products with shellfish, mustard-containing sauces or dressings, or any product made with oat, rye, or barley ingredients. A label reviewed only against FDA requirements will be missing required Canadian declarations in any of those cases.

Canada added sesame to its priority allergen list before the US did. If your Canadian label was built several years ago and has not been reviewed since, sesame was almost certainly already required, and the US side of the review caught up in 2023.

For declaration format in Canada, the requirements parallel the FDA approach: allergens must appear either in the ingredient list by their prescribed common name, or in a “Contains” statement after the ingredient list. If a “Contains” statement is used, it must be complete for all priority allergens present.

The “May Contain” Question

Precautionary allergen labeling (statements like “May contain: Peanuts” or “Produced in a facility that also handles tree nuts”) is a separate category from mandatory declaration.

In the US, precautionary allergen labeling is voluntary. There is no FDA rule that requires manufacturers to include advisory statements about cross-contact risk. What is mandatory under 21 CFR 117 is that food manufacturers implement controls to manage allergen cross-contact. The decision to communicate that risk on the label is left to the manufacturer.

In Canada, Health Canada and CFIA characterize these statements as voluntary but recommend them when cross-contact risk exists. The practical position from CFIA guidance is that pre-packaged foods where a priority allergen is present due to cross-contamination, and no precautionary statement appears on the label, are subject to enforcement action. In other words, if the risk is real and documented in your preventive controls, you should disclose it.

The recommended Canadian format for precautionary statements is “May contain: [allergen name],” using the same prescribed source name as would appear in the ingredient list.

Why Allergen Review Is Not a One-Time Step

Most founders approach allergen declarations as a box to check early in the label process. Name the ingredients, identify the allergens, list them, done.

The problem is that formulas change. Ingredients get swapped. A supplier changes a sub-ingredient and introduces a new allergen the label never anticipated. Sesame slips into a spice blend. A contract manufacturer switches to equipment shared with tree nuts.

Each of those changes is a label change, even if it looks minor from a culinary standpoint. A reviewed label reflects the formula it was built against. If the formula shifts in any way that touches an allergen category, the declaration needs to catch up.

The other pressure is market expansion. The majority of US-based food brands that move into Canada discover their label needs at least three additional declaration reviews: molluscs if shellfish is involved, mustard if any savory ingredients are sourced from mustard-adjacent processes, and gluten grains if barley, rye, or oats appear anywhere in the ingredient chain. These are not small edits to an existing panel. They are regulatory requirements with real consequences for non-compliance.

At Complion, allergen declaration is part of the full label build. Our food compliance experts verify the declaration against both FDA and Health Canada requirements before anything goes to print. If you are building a first label or reviewing a label that has not been touched since before 2023, book a free call to start.