Last verified 16 Sep 2026 · Sources
Nine ingredients trigger mandatory allergen disclosure on a U.S. food label: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. The Food Allergen Labeling and Consumer Protection Act (FALCPA, 21 U.S.C. 343(w)) named the first eight; the FASTER Act added sesame as the ninth, effective January 1, 2023. You can disclose them one of two ways: name the allergen source in parentheses right in the ingredient list, or add a separate “Contains” statement immediately after it. For tree nuts, fish, and crustacean shellfish, you have to name the specific species, not just the category.
| Quick facts | Allergen "Contains" statement |
|---|---|
| Regulation | 21 U.S.C. 343(w) (FALCPA), FASTER Act of 2021 |
| Applies to | Any packaged food containing milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, or sesame |
| Key numbers | 9 major allergens; 2 compliant disclosure methods; sesame added 2023 |
The rule
FALCPA requires that if your packaged food contains a major food allergen, your label must identify it in plain English using the allergen’s common name (FDA allergen guidance, fda.gov/media/117410/download). There are two compliant ways to do this, and you only need one:
- In the ingredient list. Name the allergen source in parentheses directly after the ingredient that contains it: “whey (milk),” “lecithin (soy),” “albumin (egg).”
- A “Contains” statement. A separate statement, placed immediately after or adjacent to the ingredient list, naming every major allergen in the product: “Contains milk, egg, wheat.” If you use this method, it has to list all major allergens present, even ones already named plainly elsewhere in the ingredient list.
Two categories need extra specificity. Tree nuts must be named by species (“almonds,” “walnuts,” “cashews”), not the umbrella term “tree nuts.” Fish and crustacean shellfish work the same way: “cod,” “tuna,” or “shrimp,” “crab,” “lobster,” rather than “fish” or “shellfish” alone. FDA’s January 2025 guidance, “Questions and Answers Regarding Food Allergen Labeling (Edition 5)” (fda.gov/media/117410/download), lists in its Table 1 the tree nuts FDA considers major allergens: almond, black walnut, Brazil nut, California walnut, cashew, filbert/hazelnut, heartnut/Japanese walnut, macadamia nut, pecan, pine nut, pistachio, and walnut. Other nuts that appeared on FDA’s older list, such as coconut, chestnut, and shea nut, are not major allergens under that 2025 guidance and don’t belong in the “Contains” statement, though they still need to appear in the ingredient list by common name.
Advisory statements about possible cross-contact, such as “may contain peanuts” or “processed in a facility that also handles tree nuts,” are voluntary. FDA does not require them, though whatever you choose to print must be truthful and not misleading; it can’t replace proper allergen controls in the plant.
The numbers
- 9 major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, sesame.
- 2 compliant disclosure methods: parenthetical in the ingredient list, or a “Contains” statement.
- January 1, 2023: effective date sesame became the ninth major allergen under the FASTER Act.
On the label
A cookie recipe uses wheat flour, butter, eggs, and soy lecithin. One compliant approach folds the allergen sources directly into the ingredient list: “wheat flour, butter (milk), eggs, sugar, soy lecithin.” An equally compliant alternative keeps the ingredient list plain and adds one line right after it: “Contains wheat, milk, egg, soy.” What’s not compliant is a hybrid that names egg and wheat in parentheses but leaves milk and soy undisclosed anywhere on the panel. Partial disclosure under either method still leaves an allergen unlabeled.
For a trail mix with almonds, cashews, and peanuts, “Contains tree nuts” alone isn’t enough; your label needs “Contains almonds, cashews, peanuts” so a shopper with a specific nut allergy (one who tolerates cashews but reacts to almonds, for instance) has that information.
Mistakes we see
- Naming the category, not the species. “Contains tree nuts” or “contains shellfish” without naming which ones is the single most common allergen labeling gap we see.
- Partial “Contains” statements. Adding a “Contains” line that lists some but not all major allergens actually present, usually because it was written before a recipe change and never updated.
- Treating “may contain” as a substitute for real disclosure. A voluntary cross-contact warning doesn’t cover an allergen that’s an actual ingredient; that still needs the parenthetical or “Contains” statement.
- Missing sesame. Recipes reformulated before 2023 sometimes still lack sesame disclosure even though tahini or sesame oil is in the ingredient list.
- Double standard between methods. Naming milk in parentheses in the ingredient list, then also writing an incomplete “Contains” line that contradicts it, instead of picking one method and using it consistently.
Related rules
Allergen disclosure lives inside the ingredient statement, since the parenthetical method places allergen names directly in that list. For the type rules governing how this statement is displayed alongside the rest of the panel, see type size and placement, and for a rundown of common errors across the whole label, see label mistakes.
Build it right
NutriLabels’ builder checks your ingredient list against the nine major allergens and generates a compliant “Contains” statement (or the parenthetical version, your choice) automatically.
A complete allergen declaration lets a shopper with a nut or sesame allergy pick up your product with confidence. Enter your recipe, then see your label: free with no card required, you see your calories, the claims you qualify for, your allergen line and the nutrient to watch, and every other value and %DV stays hidden until you unlock it. $29 unlocks every other nutrient value and %DV, every FDA format your product qualifies for, and your ingredient statement and allergen declaration, ready to print. Start your label or read how the ingredient statement works alongside it.
FAQ
What are the 9 major food allergens the FDA requires labeled?
Milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. The first eight came from FALCPA; sesame was added by the FASTER Act, effective January 1, 2023.
Do I have to use the word 'Contains' on my label?
No. You can instead name the allergen source in parentheses right after the ingredient in your ingredient list, for example, 'whey (milk).' Either method satisfies the disclosure requirement.
Can I just say 'Contains tree nuts' without naming which ones?
No. FDA guidance requires naming the specific tree nut (almonds, walnuts, pecans, and so on), not the general category. The same applies to fish and crustacean shellfish species.
Is a 'may contain traces of peanuts' warning required?
No. Advisory or precautionary statements about possible cross-contact, like 'may contain' or 'processed in a facility with,' are voluntary under federal law. They must be truthful if used, but FDA does not require them.
Does a 'Contains' statement need special type size?
It's part of the label information governed by the same general prominence and legibility rules as the rest of the panel; there's no allergen-specific type-size regulation separate from the ingredient statement it sits next to.
Related rules
Ingredient statement (descending order), Common Label Mistakes, Type size and placement, Net quantity statement. See the full all labeling rules.