Buy a full case and the price per unit drops automaticallyRequest a sample
AccountCart0
All ContainersBottlesJarsCaps & ClosuresPumps & SprayersTubs & PailsJugsDroppersTinsTubesAccessories
Industries
Learn
What goes wrong

An allergen hid in a flavor

Updated

On this page9
The shorthand was lawful for the flavor and not lawful for what was in it.

How it happens

A flavor or color is bought as a blend and declared as a blend. The allergen inside it is never surfaced, because nobody asked the supplier the second question.

The statute closes it explicitly

Notwithstanding the ingredient-list provisions or any other law, a flavoring, coloring or incidental additive that is, or bears or contains, a major food allergen is subject to the allergen labeling requirements.

Incidental additive is in that list too

So a processing aid or a carrier that would otherwise not need declaring is reached if it contains one of the nine. That is the broadest part of the sentence and the least expected.

This is the failure with real consequences

The others on these pages are paperwork. This one is the reason the rule exists, and an undeclared allergen in a decorating product used on a child’s cake is the scenario it was written for.

Cross-contact is a separate question

The statute addresses what is in the food. Shared equipment and shared facilities are a different matter with different practices behind them, and conflating the two leaves both half answered.

Ask against the list, not in general

"Is this allergen free" invites an optimistic answer. "Does this bear or contain milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans or sesame" invites a specific one.

Re-ask on every supplier change

A substituted carrier or a reformulated flavor can introduce an allergen with no change to the ingredient name you were given. The question has to be attached to the purchase, not to the product launch.

Keep the written answers, per lot if you can

A supplier statement with a date on it is what connects your label to reality. Verbal assurances do not survive a change of account manager, and this is the one failure on these pages where being wrong reaches a person rather than an inspector.

References

21 U.S.C. 343(w), the major food allergen labeling requirements. Paragraph (1) gives the two permitted forms, a "Contains" statement immediately after or adjacent to the ingredient list in type no smaller than that list, or the food source in parentheses after the ingredient name. Paragraph (4) applies the requirement to a flavoring, coloring or incidental additive notwithstanding any other law. law.cornell.edu
21 U.S.C. 321(qq), which defines major food allergen as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans and sesame, plus any food ingredient containing protein derived from one of them, excepting highly refined oils and ingredients exempt under 343(w). law.cornell.edu
21 CFR 101.22(a), which defines artificial flavor by exclusion: a substance whose function is to impart flavor and which is not derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, fish, poultry, eggs, dairy products, or fermentation products thereof. law.cornell.edu
Written from federal statute and regulation, not from a kitchen. Food labeling has more parts than three sections, and a state cottage food program may add or subtract requirements for a local sale. Nothing here is clearance for a specific label, and whether an ingredient is cleared for food use is a question about that ingredient.