Allergen Labels on Food You Wrap In-Store: The Nine Major Allergens and Where the Rules Come From

A turkey sandwich made at 6 a.m., wrapped in film and set in the cooler is a different thing, in labeling terms, from the same sandwich made while the customer waits. The first sits on a shelf with no one beside it to answer questions. The second is handed across the counter by the person who made it. Federal law and the model food code treat those two sandwiches differently, and the difference decides whether the wrapper needs an allergen statement.

This article sets out where the allergen rules come from, which foods they name, and how they apply to food a convenience store, bodega or small grocer wraps itself: grab-and-go sandwiches, salads, cut fruit and baked goods. The Label Before You Wrap checklist puts the steps on one page. The article quotes the federal statute, the FDA’s explanation of it, and the 2026 edition of the FDA Food Code, all read on 21 October 2026. Nothing here is legal advice, and a question about a specific product belongs with your local health department or a food law attorney.

Two sources of rules, and why the difference matters

Two different bodies of rules reach the same wrapped sandwich. The first is federal law. The Federal Food, Drug, and Cosmetic Act sets out what a food label must say about major food allergens in its allergen section, 21 U.S.C. 343(w), and the FDA enforces it.

The second is the FDA Food Code. Despite the name, the Food Code is not a federal regulation. The preface of the 2026 Food Code says so plainly: “The model Food Code is neither federal law nor federal regulation and is not preemptive.” The FDA describes it on its FDA Food Code page as a model: “Local, state, tribal, and federal regulators use the FDA Food Code as a model to develop or update their own food safety rules and to be consistent with national food regulatory policy.”

A Food Code provision binds your store only if your state, county or city has adopted it into its own rules, and jurisdictions adopt different editions at different times. The preface adds that the FDA’s list of adopting jurisdictions “is self-reported, and FDA has not yet evaluated whether all the adopted codes are equivalent to the model Food Code.” So read every Food Code quotation in this article as what your local rule probably looks like if it follows the model, not as a federal requirement.

The nine major food allergens

Both sources start from the same list, which the statute sets out in its definitions section, 21 U.S.C. 321(qq). The FDA’s Food Allergies page summarizes it in one sentence: “The major food allergens are milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame.”

The definition also covers “A food ingredient that contains protein derived from a food specified in paragraph (1),” with two exceptions, the first being “Any highly refined oil derived from a food specified in paragraph (1) and any ingredient derived from such highly refined oil.”

Sesame is the newest entry, and it is the one most likely to be missing from an older in-store label template. The same FDA page gives the history: “This law identified eight foods as major food allergens: milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans.” Then: “On April 23, 2021, the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act was signed into law, declaring sesame as the 9th major food allergen recognized by the United States. The change was effective on January 1, 2023.”

In a store kitchen, sesame usually arrives inside something else: seeded rolls, tahini in a spread, sesame oil in a noodle salad. If your label templates were written before 2023, check them for sesame first.

What a federal allergen declaration has to look like

The statute gives two ways to declare an allergen. Under 21 U.S.C. 343(w)(1), a food that “is, or it contains an ingredient that bears or contains, a major food allergen” is misbranded unless one of these is done:

• Option A, the “Contains” statement: “the word “Contains”, followed by the name of the food source from which the major food allergen is derived”, printed immediately after or next to the ingredient list, “(in a type size no smaller than the type size used in the list of ingredients)”.
• Option B, the parenthetical: the allergen ingredient’s name “is followed in parentheses by the name of the food source from which the major food allergen is derived”.

The FDA’s page gives examples of each: ““lecithin (soy),” “flour (wheat),” and “whey (milk)”” for the parenthetical, and “Example: “Contains wheat, milk, and soy.”” for the statement. The parenthetical is not needed when “the common or usual name of the ingredient uses the name of the food source from which the major food allergen is derived”. The FDA’s example is buttermilk, which already names milk.

Three more details catch store-made labels.

• Name the specific nut, fish or shellfish. The FDA page says: “The law also requires that the type of tree nut (for example, almonds, pecans, walnuts), and the species of fish (for example, bass, flounder, cod) and Crustacean shellfish (for example, crab, lobster, shrimp) to be declared.” A chicken salad made with walnuts needs to say walnuts.
• Flavorings and additives count. Under 343(w)(4), “a flavoring, coloring, or incidental additive that is, or that bears or contains, a major food allergen shall be subject to the labeling requirements of this subsection.” Milk or soy inside a flavoring carries through to your label.
• A “may contain” line is optional, and it is not a substitute. The FDA page says advisory statements such as “may contain” are “not required by law”, and that “advisory statements should not be used as a substitute for adhering to current good manufacturing practices and must be truthful and not misleading.”

Where federal allergen labeling stops at the store counter

This is the line that matters most for a store kitchen, and the FDA states it directly on its Food Allergies page: “FALCPA’s labeling requirements extend to retail and food-service establishments that package, label, and offer products for human consumption. However, FALCPA’s labeling requirements do not apply to foods that are placed in a wrapper or container (such as paper or a box for a sandwich) following a customer’s order at the point of purchase.”

(FALCPA is the Food Allergen Labeling and Consumer Protection Act of 2004.)

Read together, those two sentences sort store food into two groups. A sandwich or salad your staff wraps, labels and puts out for self-service falls inside the first sentence. A sandwich made to order and wrapped as it is handed over falls inside the second, and federal allergen labeling does not apply to that wrapper.

The FDA page also lists what FALCPA enforcement does not cover. Among the exclusions are “most foods sold at retail or food service establishments that are not pre-packaged with a label.” The same list says FDA enforcement “does not include meat, poultry, and egg products”, which are regulated by the U.S. Department of Agriculture. If you package meat or poultry products in-house, ask your health department which rules apply to them.

The Food Code: labels on food packaged in the store

Where adopted, the Food Code turns the same line into an inspection item. In the Food Code quotations, an asterisk and capital letters mark a term the Food Code defines in its Chapter 1. They are kept exactly as they appear in the 2026 edition.

Section 3-602.11, Food Labels, starts with a general rule: “*FOOD *PACKAGED in a *FOOD ESTABLISHMENT, shall be labeled as specified in *LAW, including 21 CFR 101 – Food labeling, and 9 CFR 317 Labeling, marking devices, and containers.”

Paragraph (B) then lists the label contents: the common name, the ingredient list, “An accurate declaration of the net quantity of contents;” and “The name and place of business of the manufacturer, packer, or distributor; and” then the allergen line, (B)(5): “The name of the *FOOD source for each *MAJOR FOOD ALLERGEN contained in the *FOOD unless the *FOOD source is already part of the common or usual name of the respective ingredient.”

The next item, nutrition labeling, opens with “Except as exempted in the Federal Food, Drug, and Cosmetic Act § 403(q)(3) – (5),” and the Food Code’s Annex 3 lists nutrition labeling exemptions for some store-made foods. Those exemptions are for nutrition labeling. The allergen line carries no exemption clause of its own; the section’s one exemption is paragraph (D), which excuses some unpackaged foods from a label altogether.

What counts as “packaged” under the Food Code

Whether 3-602.11 applies to a given item turns on the Food Code’s definition of packaged. Chapter 1 says it “means bottled, canned, cartoned, bagged, or wrapped, whether *PACKAGED in a *FOOD ESTABLISHMENT or a *FOOD PROCESSING PLANT.” The second part of the definition draws the same line the FDA draws: packaged “does not include wrapped or placed in a carry-out container to protect the *FOOD during service or delivery to the *CONSUMER, by a *FOOD EMPLOYEE, upon *CONSUMER request.”

Annex 3 of the Food Code explains the reasoning. “When a consumer orders a specific food or specific amount of food from a food employee, that employee may put the food in a wrapper or carry-out container at the time the order is placed. This food is not considered “packaged”, per the Food Code definition”. The reason given is that the customer can ask: “the consumer has an opportunity to ask about ingredients, nutrients, allergens and weight.”

For self-service food, it says, “the label provides an important source of information for consumers to answer questions about ingredients, allergens, weight, and manufacturer.” The test is whether the food was wrapped on the customer’s request or wrapped ahead for customers to pick up without asking anyone.

Unpackaged food: the written notice rule

Food that is not packaged is not exempt from allergen information under the model code. Section 3-602.12, Other Forms of Information, says in paragraph (C): “The *PERMIT HOLDER shall notify *CONSUMERS by written notification of the presence of *MAJOR FOOD ALLERGENS as an ingredient in un*PACKAGED *FOOD items that are served or sold to the *CONSUMER.”

Annex 3 lists the forms that notice can take: “Written notification can be provided in many forms such as: physical or electronic means, including, but not limited to, brochures, deli case or menu notifications, label statements, table tents, placards, or other effective written means.”

Paragraph (C) was new in the 2022 edition. The 2017 edition’s 3-602.12 has only paragraphs (A) and (B), and the summary of changes in the 2022 Food Code (PDF) records that the section was “Amended to add new ¶ 3-602.12(C) to inform consumers of major food allergens in unpackaged foods via written means.” A jurisdiction working from the 2017 edition or earlier does not have it.

This rule reaches food that 3-602.11 lets go without a label. Paragraph (D) of 3-602.11 says that “Bulk, un*PACKAGED *FOODS such as bakery products and un*PACKAGED *FOODS that are portioned to *CONSUMER specification need not be labeled if” three conditions are met. The conditions are that “A health, nutrient content, or other claim is not made;” that “There are no state or local *LAWS requiring labeling; and” that the food is made on the premises, or at another establishment or processing plant owned by the same person and regulated by the agency with jurisdiction. The inspection guide in the Food Code’s Annex 7 joins the two rules: “In addition, all unpackaged food items containing a major food allergen as an ingredient must have a written notification declaring which major food allergens are contained in that food item.”

So an open tray of muffins made with wheat, egg and milk may need no label under the model code, but it still needs a written allergen notice, such as a card on the case.

Who in the store has to know

The Food Code also puts allergen knowledge on people. Section 2-102.11 lets a person in charge show knowledge by “Responding correctly to the inspector’s questions as they relate to the specific *FOOD operation.” One listed area is “Describing *FOODS identified as *MAJOR FOOD ALLERGENS and the symptoms that a *MAJOR FOOD ALLERGEN could cause in a sensitive individual who has an allergic reaction.”

Under section 2-103.11, the person in charge also ensures that “*EMPLOYEES are properly trained in *FOOD safety, including *FOOD allergy awareness, as it relates to their assigned duties.”

The three ways food leaves your counter

Side by side, the sources give three situations. The Food Code column applies only where your jurisdiction has adopted the matching provision.

Confusion comes from items that move between rows. A sandwich made to order is in row two. The same sandwich made in a morning batch and stacked in the cooler is in row one.

Label Before You Wrap: a one-page checklist

Run these steps once for every new store-made item, and again whenever a recipe or supplier changes. Keep the completed sheet with the item’s recipe.

1. Decide the row. Will this item be wrapped ahead for self-service, wrapped on request, or sold unwrapped? Wrapped ahead means a full label. Unwrapped or made to order means a written notice, where your local code requires one.
2. List every ingredient, down to the sub-ingredient. Copy the ingredient list of each bought-in component. The Food Code asks for “a list of ingredients and sub-ingredients in descending order of predominance by weight”.
3. Run the nine. Check the full list against milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans and sesame. Include flavorings, colorings and incidental additives, which 343(w)(4) brings in.
4. Name it the way the law names it. Write the specific tree nut, fish species or shellfish species, not the category. Use either a “Contains” statement next to the ingredient list or a parenthetical after the ingredient name, and keep the “Contains” type no smaller than the ingredient list type.
5. Check sesame separately. If your template predates 2023, look for seeded bread, tahini and sesame oil. Ask your supplier whether a sesame oil is highly refined before leaving it off, and record the answer.
6. Fill in the rest of the label. Under the model code: common name, net quantity, and the packer’s name and place of business. Your local code may require more.
7. Write the notice for unwrapped food. Put the major food allergens in writing where customers see them: a case card, menu line or sign.
8. Re-check on any change. A new bread supplier or a swapped dressing can add an allergen overnight.
9. Train the counter. Whoever wraps the food or answers questions should be able to name the nine allergens and find them in your recipes.

Two further habits are store policy, not law. Some stores put a full allergen label even on items the rules would let go unlabeled, because one label format is easier to run than two. And a store may decide never to use a “may contain” line, since the FDA says such statements are not required.

Where state and local law fit

Every rule in this article is either federal law or a model code. State and local law can go further, and the Food Code itself expects that: one of its conditions for leaving bakery products unlabeled is that “There are no state or local *LAWS requiring labeling”. If your state or city sets a stricter labeling or notice rule, the stricter rule applies to your store. This article does not summarize any state’s rules. Your state or local health department can tell you its rules and which Food Code edition, if any, it has adopted.

Where the POS fits, and where it does not

A register does not write ingredient statements, and an allergen label is a separate job from ringing up a sale. Where the POS helps is in keeping a complete list of what you make. NRS’s point-of-sale page says the system “will also let you add in-store products like hot foods that you can ring up with a quick scan or press of a button.” Every store-made item that has its own entry in the price book is an item that should have a completed Label Before You Wrap sheet behind it, so the price book doubles as a checklist of labels to review.

If you are planning a fresh food program, NRS’s guide to launching a hot food and grab-and-go program covers the wider setup. For the permit side, see NRS’s walk-through on how to get a food service license.

What this article leaves out. It gives no penalty amounts and no state rules, because none of the sources quoted state them. It does not cover USDA rules for meat and poultry products, nutrition labeling, or gluten-free claims, and it does not decide whether any particular product is regulated by the FDA or the USDA. The statute was read on the Legal Information Institute’s copy of the U.S. Code, and the FDA pages and the FDA Food Code 2026 (PDF) on fda.gov, all on 21 October 2026; the 2017 and 2022 editions were read on 27 October 2026. All of them can change.

Frequently asked questions

Key takeaways

• Two bodies of rules apply: federal law, which the FDA enforces, and the model Food Code, which applies only where a state or locality has adopted it.
• There are nine major food allergens: milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans and sesame. Sesame was added effective January 1, 2023.
• Food a store packages and labels for self-service falls under federal allergen labeling. Food wrapped after the customer orders does not.
• A declaration uses either a “Contains” statement next to the ingredient list or a parenthetical after the ingredient, and names the specific nut, fish or shellfish.
• Under the model Food Code, food packaged in the store needs a label that names the food source of each major food allergen.
• Unpackaged food, including bakery items that need no label, still needs a written allergen notice where the 2022 or 2026 Food Code provision has been adopted; the provision was new in 2022.
• The stricter rule wins, so check your state and local health department before a new item goes into the cooler.