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Allergen Labeling Requirements (FALCPA)

Quick answer

Allergen labeling requirements under FALCPA and the FASTER Act say a packaged food must name every major food allergen it contains: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame. Name it in the ingredient list, like "whey (milk)", or in a "Contains" statement right after the list. Tree nuts, fish and shellfish need the specific kind, like "pecans" or "shrimp".

Allergen labeling requirements in practice: an ingredient list with allergens named in parentheses and a Contains statement below it listing wheat, milk, eggs and pecans
Two legal ways to declare allergens on one label
01

The 9 major food allergens

More than 160 foods can cause allergic reactions, but federal law names nine as major food allergens. Any ingredient that contains protein from one of them counts too.

FDA Major Food Allergens →
  • Milk
  • Eggs
  • Fish
  • Crustacean shellfish
  • Tree nuts
  • Peanuts
  • Wheat
  • Soybeans
  • Sesame
21 U.S.C. 321(qq)The legal definition of a major food allergen. Sesame was added by the FASTER Act.
02

Two ways to declare an allergen

MethodExampleRule
In the ingredient listwhey (milk), lecithin (soy)Allergen in parentheses after the ingredient
Contains statementContains: wheat, milk, soy.Right after or next to the ingredient list
  • No extra mention is needed when the ingredient name already says it, like "wheat flour" or "buttermilk"
  • The Contains statement can't be in smaller type than the ingredient list
  • If you use a Contains statement, it must list every major allergen in the food, even ones the ingredient list already names
21 U.S.C. 343(w)(1)The two ways to declare, the type size rule, and when the ingredient name is enough.
03

Name the nut, the fish, the shellfish

"Contains: tree nuts" is not enough. For tree nuts, fish and crustacean shellfish, the label must name the specific type: "Contains: cashews", "Contains: cod", "Contains: shrimp".

FDA's current list of tree nuts that count as major allergens has these entries:

  • Almond
  • Black walnut
  • Brazil nut
  • California walnut
  • Cashew
  • Filbert/Hazelnut
  • Heartnut/Japanese walnut
  • Macadamia nut/Bush nut
  • Pecan
  • Pine nut/Pinon nut
  • Pistachio
  • Walnut (English, Persian)
  • Coconut is no longer on the list, so it doesn't belong in the Contains statement. It still goes in the ingredient list
  • Milk from goats, sheep and other ruminants counts as milk: write "Contains: goat milk"
  • Eggs from ducks, quail and other birds count as eggs: write "Contains: duck eggs"
21 U.S.C. 343(w)(2) · FDA Allergen Q&A, Edition 5The specific-name rule in the law, and FDA's tree nut list (Table 1) with its guidance on milk and eggs.
04

Flavors, colors, additives and oils

  • Flavorings, colorings and incidental additives with an allergen must be declared, even where the list would only say "natural flavor" or leave them out
  • A seasoning mix with an allergen in it needs the allergen declared on your finished food
  • Highly refined oils are not major food allergens, but the ingredient list still names the source, like "soybean oil"
  • An ingredient made from an allergen is exempt only if it has none of its protein, or FDA accepts a petition or notification
21 U.S.C. 343(w)(4), (6), (7) · 321(qq)(2)Flavors, colors and incidental additives; the petition and notification routes; the highly refined oil exception.
05

What the Contains statement is not for

  • Not for allergens outside the 9, or for things people are sensitive to, like sulfites. Put those in a separate statement
  • Not for allergens that aren't in the recipe. Listing them anyway does not comply with FDA's rules
  • Not for possible traces from shared equipment. That is what a voluntary "may contain" statement is for
"May contain" labeling: what the FDA allows →
06

Example: a pecan brownie label

Ingredients: Sugar, wheat flour, butter (cream, salt), eggs, pecans, cocoa, vanilla extract, salt. Contains: wheat, milk, eggs, pecans.

  • "Wheat flour" already names wheat, but wheat is still in the Contains line because a Contains line must list all of them
  • "Butter (cream, salt)" never says milk, so milk must appear somewhere: here, in the Contains line
  • Pecans are named by kind, not as "tree nuts"

Our tool does this for you: it flags all 9 major allergens from your recipe and writes the Contains line with the specific nut, fish or shellfish.

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07

Allergen label checklist

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Questions

Questions

The Food Allergen Labeling and Consumer Protection Act. It created the major food allergen rules in the FD&C Act. The FASTER Act later added sesame as the ninth major allergen.

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