Allergen Labeling: What You Need to Know
Allergen labeling is one of the most critical and highly scrutinized parts of food labeling.
However, getting allergen labeling right isn’t always straightforward. Packaged food, beverage, and supplement teams need to navigate:
- Sub-allergen labeling (labeling specific species or types of allergen groups)
- Precautionary allergen labeling (for example, “May contain” statements)
Allergen labeling plays a key role in protecting consumers, and getting it wrong can introduce serious regulatory and safety risks.
Here’s what you need to know for compliant allergen labeling in the U.S. and Canada.
Allergen Labeling in the U.S.
In the U.S., there are 9 “major food allergens”. Under section 201(qq) of the FD&C Act, a “major food allergen” is one of the following foods or food groups, or an ingredient that contains protein derived from one of the following:
- Milk
- Eggs
- Peanuts
- Wheat
- Soybeans
- Sesame
- Fish
- Crustacean Shellfish
- Tree Nuts
However, for three of these allergen categories, you must declare the specific species or type on the label:
- Fish
- Crustacean shellfish
- Tree nuts
For Fish and Crustacean Shellfish, you can find a list of acceptable names on this website.
For Tree Nuts, the FDA now only recognizes the following 12 tree nuts as major allergens: Almond, Black walnut, Brazil nut, California walnut, Cashew, Filbert (Hazelnut), Heartnut/Japanese walnut, Macadamia nut/Bush nut, Pine nut (Pinon nut), Pistachio, Walnut (English, Persian).
Recent FDA guidance also clarifies that:
- Milk from non-cow sources must be specified (e.g., goat milk)
- Eggs from non-chicken sources must be specified (e.g., duck eggs)
Allergen Labeling in Canada
Allergen labeling in Canada is defined under Health Canada/CFIA requirements for allergen labeling in section B.01.010.1(1), FDR. In Canada, a food allergen means any protein from any of the following foods, or any modified protein, including any protein fraction, that is derived from any of the following foods:
- Almonds, Brazil nuts, Cashews, Hazelnuts, Macadamia nuts, Pecans, Pine nuts, Pistachios or Walnuts
- Peanuts
- Sesame seeds
- Wheat or Triticale
- Eggs
- Milk
- Soybeans
- Crustaceans
- Molluscs
- Fish
- Mustard seeds
For three of these allergen categories, Fish, Crustaceans and Molluscs, you must declare the specific species or type on the label. A list of acceptable names can be found on this website.
Per the requirements, sources of gluten (barley, oats, rye, triticale or wheat) must also be declared if present in the product, and sulfites should be declared if the formula has more than 10 mg/kg or PPM.
Source: Food and Drug Regulations, B.01.010.1(1)
Precautionary Allergen Labeling
Precautionary allergen statements, such as “May contain peanuts”, are widely used on packaged goods but often misunderstood.
In both the U.S. and Canada, precautionary allergen labeling is voluntary and not mandated by law.
That said, regulators expect these statements to be:
- Truthful and not misleading
- Based on real cross-contact risk, not used as blanket protection
Why This Matters for R&D and Regulatory Teams
Sub-allergen details and precautionary statements aren’t edge cases - they’re essential for:
- Consumer safety
- Regulatory compliance
- Accurate label generation
- Audit readiness
As formulations become more complex, with more suppliers, ingredients, and global markets, manual tracking gets increasingly risky.
How ENTR Helps
ENTR supports complete allergen labeling requirements for the U.S. and Canada.
With ENTR, teams can:
- Automatically flag major allergens and sub-types
- Generate accurate “Contains” statements
- Add and manage “May contain” (precautionary) statements
- Ensure consistency across formulations and labels
Allergen labeling isn’t just about checking a box - it’s about precision and protection. The details matter, and getting it right requires systems that are built for it.
