Updated 2026-10-03. This page is not legal advice.
United States law names 9 major food allergens. A packaged food that contains one must name it on the label. The list includes milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. This guide gives each allergen, the exact name to print, and how the US list compares with others. It also explains the labeling rules you must follow under federal law.
What are the 9 major food allergens?
Federal law establishes nine foods as major allergens under 21 U.S.C. 321(qq)(1). Every food business must identify these items on packaged food products. The table below lists the legal scope, the required name, and ingredient examples for each allergen.
| Allergen | What the law or FDA counts | Name to print | Example in an ingredient list |
|---|---|---|---|
| milk | milk from cows, goats, sheep, or other ruminants | milk | whey (milk) |
| eggs | eggs from chickens, ducks, geese, quail, or other fowl | egg | albumen (egg) |
| fish | for example bass, flounder, or cod | the kind of fish, such as cod | fish sauce (anchovy) |
| crustacean shellfish | for example crab, lobster, or shrimp | the kind, such as shrimp | natural flavor (shrimp) |
| tree nuts | for example almonds, pecans, or walnuts | the kind of nut, such as almonds | praline paste (pecans) |
| peanuts | peanuts | peanuts | peanut flour (no parentheses needed) |
| wheat | wheat | wheat | semolina (wheat) |
| soybeans | soybeans | soybeans | lecithin (soybeans) |
| sesame | sesame, added in 2023 | sesame | tahini (sesame) |
The term “major food allergen” also covers any ingredient that holds protein from one of these foods.
Why do some lists say 8 and others say 9?
Many older food guides refer to the big 8 allergens. The Food Allergen Labeling and Consumer Protection Act of 2004 named the first list. People call this law FALCPA. It named eight foods: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans.
The Food Allergy Safety, Treatment, Education, and Research Act of 2021 came next. People call it the FASTER Act. Congress passed it in April 2021. It added sesame to the list.
Labels had to include sesame starting on January 1, 2023. That is why people now say the big 9 allergens. The big 8 is the old list. A packaged food sold today must declare all nine.
What changed in FDA’s 2025 allergen guidance?
In January 2025, the FDA issued Edition 5 of its allergen questions and answers. This guidance changed how the FDA reads some of the nine foods.
The update clarified the legal definition of milk. Milk now means milk from cows, goats, sheep, or other ruminants. In earlier guidance, the FDA interpreted milk only as cow milk. If you use goat milk or sheep milk, you must now label it as milk.
The agency also expanded the official definition of eggs. Eggs now means eggs from chickens, ducks, geese, quail, or other fowl. Previously, the agency limited this category to chicken eggs. If you use duck eggs or quail eggs, you must now declare egg.
The FDA also revised its list of tree nuts. The law names almonds, pecans, and walnuts as examples. Other nuts can count too. Check the FDA’s current tree nut list before you label any other nut.
What are the 14 allergens?
International markets enforce distinct allergen declaration requirements. The list of fourteen foreign allergens comes from European Union food information rules. Regulation (EU) No 1169/2011, Annex II lists them. The United Kingdom uses the exact same list of 14 allergens.
The table below compares the European and British standard against United States law.
| Allergen (EU/UK list) | On the US list of 9? |
|---|---|
| cereals containing gluten (wheat, rye, barley, oats) | wheat only |
| crustaceans | yes |
| eggs | yes |
| fish | yes |
| peanuts | yes |
| soybeans | yes |
| milk | yes |
| nuts (almonds, hazelnuts, walnuts, cashews, pecans, Brazil nuts, pistachios, macadamia) | yes, as tree nuts |
| celery | no |
| mustard | no |
| sesame seeds | yes |
| sulphur dioxide and sulphites above 10 mg/kg or 10 mg/litre | no |
| lupin | no |
| molluscs | no |
A food sold in the US follows the US list of 9. You do not need to declare celery, mustard, or lupin on domestic labels. However, you must declare every applicable United States allergen.
How do you name a major food allergen on a US label?
United States law establishes two distinct labeling methods under 21 U.S.C. 343(w)(1). A food manufacturer must use at least one of these two options.
The first method is a dedicated “Contains” statement. You print the word “Contains” followed by the food source name. You must position this statement right after or next to the ingredient list. The print size must be no smaller than the type size in the ingredient list. Review our guide to writing an allergen statement for detailed formatting instructions.
The second method declares the allergen inside your ingredient statement. You place the food source name in parentheses after the common ingredient name. For example, you would write “whey (milk)” or “lecithin (soybeans)”. You do not need parentheses when the ingredient name already uses the food source name. For example, “wheat flour” already names the food source directly. You also do not need parentheses in another case. Omit them when the food source name already appears elsewhere in the list.
Specific rules govern three categories under 21 U.S.C. 343(w)(2). For tree nuts, fish, and crustacean shellfish, you must state the specific food source. You cannot simply list “tree nuts” on your label. You must name the specific nut, such as almonds or pecans. You cannot write “fish” on your packaging. You must name the specific fish species, such as cod or flounder. You must also name the specific crustacean shellfish, such as shrimp or crab.
Flavorings, colorings, and incidental additives follow these same statutory requirements under 21 U.S.C. 343(w)(4). If a spice blend or coloring contains an allergen protein, you must declare that food source.
What does not count as a major food allergen?
The law leaves some ingredients out of the definition. These ingredients come from the nine foods but do not count as major food allergens.
Under 21 U.S.C. 321(qq)(2)(A), the statute excludes highly refined oils. A highly refined oil made from one of the 9 foods does not count as an allergen. Any ingredient made from that highly refined oil is also exempt.
The law also leaves out an ingredient the FDA exempts after a petition or a notification under 21 U.S.C. 343(w)(6) and (7). Any person can petition the FDA to exempt an ingredient. The petitioner must show that the ingredient does not cause an allergic response that poses a risk to human health.
In addition, federal allergen rules do not apply to raw agricultural commodities. A raw agricultural commodity is a farm food in its raw or natural state. Whole raw fruits and fresh raw vegetables fall outside the requirements of 21 U.S.C. 343(w). An unprocessed apple or loose head of lettuce does not require allergen labeling.
Do cottage foods need an allergen label?
Cottage food laws let people make some foods in a home kitchen and sell them. In every state we have checked, a cottage food label must name the major food allergens.
The state rules point to the same nine foods as the federal list.
Start from our cottage food label template. Then find your state in the cottage food laws by state list. Check your state page before you sell.
How do you make a label with the allergens on it?
Our free ingredient label maker sorts your ingredients by weight. It adds the “Contains” line for you. Read the food label requirements for the other parts of the label.