US food allergen labeling: the 9 major allergens and FDA rules
In the United States, nine major food allergens must be declared on the label: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame. The law sets how to declare them, in the ingredient list or in a “Contains” statement. Unlike the declaration of allergens present as ingredients, precautionary statements such as “may contain” are not subject to specific presentation rules. The FDA still reminds manufacturers that they must not be misleading. And the FDA guidance of January 2025 changed the scope of milk, eggs and tree nuts.
The nine major food allergens
The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) defined eight major food allergens. The FASTER Act, signed on April 23, 2021, added sesame as the ninth, effective January 1, 2023. Each must be declared by the name of its food source, with more detail for some of them. The examples in the table reflect US requirements.
| Major allergen | How to declare it |
|---|---|
| Milk | Milk from cows, goats, sheep or other ruminants. Declare each source separately, for example “milk, goat milk” |
| Eggs | Eggs from chickens, ducks, geese, quail or other fowl, for example “eggs, duck eggs” |
| Fish | The species, for example bass or cod |
| Crustacean shellfish | The species, for example shrimp or crab |
| Tree nuts | The specific nut, from the FDA tree nut list. Coconut is no longer on it as a major allergen, but it is still declared as an ingredient |
| Peanuts | “Peanuts” |
| Wheat | “Wheat” |
| Soybeans | “Soybeans”, or the synonyms “soy” and “soya” |
| Sesame | “Sesame”, since January 1, 2023 |
Some highly refined oils derived from a major allergen are exempt, under the conditions set by US law. Incidental additives and processing aids are not: if one is or contains a major allergen, you must declare it, even though it does not appear in the ingredient list.
How to write the “Contains” statement
You declare each major allergen in one of two ways. Either the ingredient list names the source, for example “lecithin (soy)”. Or a “Contains” statement appears immediately after or next to the ingredient list.
“May contain”: what the FDA allows
Allergen labeling requirements do not apply to cross-contact. An allergen present through shared equipment or production sequencing is not declared in the ingredient list or in the “Contains” statement. The law does not regulate advisory statements such as “may contain” or “produced in a facility that also processes”.
The FDA still sets limits. An advisory statement must be truthful and not misleading. It is never a substitute for good manufacturing practices or for the allergen preventive controls of 21 CFR part 117. A product that contains milk as an ingredient must not also say “may contain milk”. A “milk-free” claim cannot sit next to a “may contain milk” statement either.
The United States has no regulatory threshold for cross-contact. The FDA held a public meeting on allergen thresholds on February 18, 2026, without a rule so far.
What changed with the January 2025 guidance
On January 6, 2025, the FDA finalized the fifth edition of its questions and answers on food allergens, after a draft of November 29, 2022. It clarifies, in particular, which animal species fall under the “milk” and “eggs” categories. The tree nut list dropped coconut and eleven other nuts, such as shea nut and chestnut. These must still appear in the ingredient list, but not in the “Contains” statement. The same day, the FDA finalized its approach for evaluating allergens other than the nine.
The uniform compliance date of January 1, 2028 does not apply to these changes. The FDA accepts that labels that no longer present coconut as a major allergen are corrected at the next printing. Coconut must still be declared as an ingredient when the recipe contains it. For goat milk and duck eggs, it recommends label changes as soon as practicable.
From raw material to label with beCPG
A correct label starts with raw material data. In beCPG, you enter each allergen on the raw material, present voluntarily or through cross-contact. Linking an allergen to an ingredient in the administration adds it to every raw material containing that ingredient, and you can add allergens, for example goat milk next to cow milk.
Cross-contact is declared on resources that represent a production line or a site, with a “May contain” field and an “Is the risk managed” field. Formulation rolls voluntary and cross-contact allergens up to the finished product. beCPG never applies a precautionary statement to an allergen declared as voluntary, which matches the FDA position. For your own threshold policy, beCPG ships the VITAL 3.0, VITAL 4.0 and Dutch reference dose frameworks, which compute an action limit from the serving size.
beCPG generates the ingredient list and the allergen statements according to the labeling rules configured for the target market. A rename rule handles the US “contains less than 2% of” wording. The same formula also produces the US Nutrition Facts label in the FDA formats. For the general method, see our post on allergen control.
The nine allergens are easy to list; keeping them right across recipes and supplier changes is the real work. To see it on your products, request a demo.
Frequently asked questions
Is a “may contain” statement mandatory in the US?
No. The law does not require advisory statements, and no specific presentation rules apply to them. If you use one, it must be truthful and not misleading, and it cannot replace good manufacturing practices or allergen preventive controls.
Do I have to declare coconut as a tree nut?
No, not since the January 2025 FDA guidance. Coconut is no longer on the tree nut list. You still name it in the ingredient list, but it does not belong in the “Contains” statement.
Is mustard a major allergen in the United States?
No. The United States has nine major allergens, and mustard is not one of them, unlike in the European Union or Canada. Do not add it to the “Contains” statement; a separate statement is possible if it is truthful.
Sources
- FDA, Food Allergies: What You Need to Know
- FDA, Questions and Answers Regarding Food Allergens (Edition 5), January 2025
- FDA, Frequently Asked Questions: Food Allergen Labeling Guidance for Industry
- FDA, Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens
- 21 CFR part 117 and FASTER Act of 2021 (Pub. L. 117-11)
