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Allergen Statement

Quick answer

Allergen statement is the usual name for the "Contains" line printed right after a food's ingredient list, like "Contains: wheat, milk, eggs, pecans." Start it with the word Contains, name every major food allergen in the food, use the specific nut, fish or shellfish, and print it no smaller than the ingredient list. It's optional when the ingredient list already names each allergen, but once you add one, it must list all of them.

Allergen statement on a cookie package: the line Contains: wheat, milk, eggs, soy printed directly under the ingredient list
One line, right after the ingredients: "Contains:" plus every allergen
01

The formula for a Contains line

The simplest compliant version is the word "Contains" followed by the names of the allergen sources: "Contains: milk, egg, peanuts." FDA also accepts extra wording, as long as three conditions hold:

  • The first word is "Contains", with a capital C. Bold and punctuation, like the colon, are optional
  • The allergens carry the names the law uses. Singular is fine ("walnut" for "walnuts"), and "soy" or "soya" may replace "soybeans"
  • Every major food allergen in the food or its ingredients is named, not just the ones the ingredient list missed

Two more rules come straight from the law: the line goes immediately after or next to the ingredient list, and its type is no smaller than the type of the list.

21 U.S.C. 343(w)(1)(A) · FDA Allergen Q&A, Edition 5, C.10, C.11, D.6, D.7Placement and type size, accepted wording, singular names and synonyms, and why the line must be complete.
02

What to call each allergen

AllergenWriteWatch out for
MilkmilkGoat or sheep milk: "goat milk", "sheep milk"
Eggsegg or eggsDuck, quail or other fowl: "duck egg"
Fishthe species: cod, salmon, anchovy"fish" alone is not enough
Crustacean shellfishthe species: shrimp, crab, lobster"shellfish" alone is not enough
Tree nutsthe nut: almonds, cashews, pecans"tree nuts" alone is not enough; coconut is not on FDA's list
Peanutspeanuts or peanutPeanuts are not tree nuts; name them separately
WheatwheatSpelt, durum, semolina, einkorn and triticale are all wheat
Soybeanssoy, soya, soybean or soybeansSoy lecithin in chocolate is the classic hidden source
SesamesesameTahini, and sesame inside a spice blend

For the Contains line, FDA lets you use a fish's generic name, like "salmon" for chum salmon, even though the ingredient list uses the market name.

21 U.S.C. 343(w)(2) · FDA Allergen Q&A, Edition 5, C.1 to C.9The specific-name rule, milk and eggs from other animals, fish and shellfish species, FDA's tree nut list and the species that count as wheat.
03

Allergen statement examples

Here is how the line comes out for ten different foods. Each one shows a different rule at work.

ProductAllergen ingredients in the recipeAllergen statementWhy
Chocolate chip cookiesWheat flour, butter, eggs, chocolate chips with soy lecithinContains: wheat, milk, eggs, soy.Butter never says "milk"; the soy is inside the chips
Basil pestoParmesan, pine nutsContains: milk, pine nuts.The tree nut is named, not "tree nuts"
Caesar dressingAnchovies, egg yolks, parmesanContains: anchovy, egg, milk.The fish is named by species
Crab cakesCrab, bread crumbs, mayonnaise with eggsContains: crab, wheat, egg.Shellfish by species; the bread crumbs bring the wheat
HummusTahiniContains: sesame.Tahini is made from sesame seeds
Trail mixAlmonds, cashews, peanutsContains: almonds, cashews, peanuts.Each nut is listed; peanuts stand on their own
BBQ dry rubSesame inside "spices"Contains: sesame.Or write "spices (sesame)" in the list
Goat cheese spreadGoat cheeseContains: goat milk.Name the animal for milk other than cow's
Coconut macaroonsCoconut, egg whitesContains: egg.Coconut stays in the ingredient list but not in this line
Rice crackersWheat flour dusted on the belt as a processing aidContains: wheat.Incidental additives still need declaring
FDA Allergen Q&A, Edition 5, B.4, B.5, C.2, C.8, D.8 · 21 U.S.C. 343(w)(4)Sesame in spices, goat milk, tree nuts outside FDA's list, and allergens used as processing aids.
04

Where the allergen statement goes

Your packagePut the Contains line
A normal label with an ingredient listImmediately after the list, or next to it
A single-ingredient food with no list, like "pecans"FDA recommends right above the name and address of the maker, packer or distributor
Inner units of a multipack with no ingredient listNear the product name on each unit, unless the unit is a plain, unprinted sleeve
A dietary supplement without an ingredient listOutside the Supplement Facts panel, right after or next to it

The ingredient list itself must be at least 1/16 inch tall, measured on a lowercase o, and the Contains line can't be smaller than the list. In practice they're set in the same size, one after the other.

21 U.S.C. 343(w)(1)(A) · 21 CFR 101.2(c) · FDA Allergen Q&A, Edition 5, D.2, D.3, E.3Placement next to the ingredient list, minimum type size, and FDA's advice for single-ingredient foods, multipacks and supplements.
05

Do you need an allergen statement at all?

Not always. If your ingredient list already names the source of every allergen, through names like "wheat flour" or parentheses like "whey (milk)", the law is met without a Contains line.

Many makers add one anyway, because shoppers look for it. Just remember the trade: the moment you print a Contains line, it has to repeat every allergen, including those the list already names.

21 U.S.C. 343(w)(1) · FDA Allergen Q&A, Edition 5, D.1, D.6Either declaration method is enough, and a Contains statement must be complete.
The full allergen labeling rules →
06

Mistakes that make the line non-compliant

  • "Contains: tree nuts" or "Contains: shellfish" instead of the specific kind
  • A partial list: only the allergens the ingredient list didn't already show
  • Adding sulfites, coconut, mustard or other things outside the nine. Put those in a separate statement if you want to mention them
  • Listing allergens that aren't in the recipe, just to be safe
  • Printing "Contains milk" and "may contain milk" on the same product
  • Putting traces from shared equipment in the Contains line. That's cross-contact, not an ingredient
  • Setting the line in smaller type than the ingredient list
FDA Allergen Q&A, Edition 5, C.5, C.8, D.6, D.7, D.8, D.10, D.11, D.14Specific names, tree nuts outside the list, complete statements, cross-contact and mixed advisory statements.
07

Allergen statement vs. "may contain"

The Contains line declares what you put in the food, and the law requires it in one of its two forms. A "may contain" line warns about what might get in by accident. It's voluntary, it must be truthful, and it never replaces good manufacturing practice. Keep the two apart on the label.

"May Contain" Allergen Labeling →
08

Let the label maker write the line

  • Flags all 9 major allergens from your recipe, including sub-ingredients like the soy lecithin in chocolate chips
  • Names the specific tree nut, fish or shellfish in the Contains line
  • Lets you add an allergen by hand when a supplier's label shows one
  • Prints INGREDIENTS and CONTAINS under the Nutrition Facts in the same 9 point type
Make your allergen label →
09

Allergen statement checklist

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Questions

Questions

No. FDA says bold text and punctuation in the Contains statement are optional. "Contains: milk, wheat" and "Contains milk, wheat" both work.

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