The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) mandates that packaged food items must declare, in plain language, the presence of any major food allergens on the product packaging.
The law defines a major food allergen to mean any one of the following nine foods or food groups (or an ingredient that contains their proteins): Milk, Egg, Fish, Crustacean shellfish, Tree nuts, Wheat, Peanuts, Soybeans, and Sesame.
To comply with FALCPA requirements, food packages must display allergens using their common name and list them either:
Or
Below we will discuss each of the U.S. allergens and their declaration requirements, including allowable synonyms and specific types/species.
Single-ingredient products, or products containing milk or milk protein, must include “milk” in the Contains statement or ingredient statement. No synonyms apply.
For Fish and Crustacean Shellfish, you must declare the specific species of seafood by using either the common name or acceptable market name. The Scientific name (the Latin name for the genus and species of the fish) or Vernacular name is NOT acceptable.
When determining how to appropriately label a seafood allergen, you can check The Seafood List and search by Market Name, Common Name, and/or Scientific Name. There are nearly 2,000 records of fish and shellfish in this list, which is updated regularly. An asterisk (*) next to the Market Name indicates that a regulation pertains to that species. Additional information can be found in the Seafood List Guidance on the FDA’s website.
Please note: Some records may display the vernacular names for species. This is for cross-reference ONLY. The scientific and vernacular names are not acceptable to list on the product package.
This table shows examples of acceptable market names and common names when listing fish species in an allergen statement.
Single-ingredient products, or products containing soybeans or soybean protein, must include “soybean” (or one of the approved synonyms) in the Contains statement or ingredient statement.
However, “Soybeans” should be used as the common or usual name to properly identify the ingredient for packaged foods using soybeans as an ingredient or as part of a multi-component ingredient (e.g., miso or tofu). The appropriate declaration would appear as such within the ingredients list: miso (fermented soybeans, salt, koji).
Synonyms: soybean, soy, and soya.
Single-ingredient products, or products containing sesame or sesame protein, must include “sesame” in the Contains statement or ingredient statement. No other synonyms apply.
Genesis Foods offers features to help with compliance. Check out these related resources:
To learn more, read this article Guidance for Industry: Questions and Answers Regarding Food Allergens (Edition 4) on the FDA’s website.