Look at any week of FDA recall announcements, including the live feed on our Regulatory Watch, and undeclared allergens appear again and again. They are consistently among the leading causes of food recalls, and nearly all of them are preventable.
The nine major food allergens
US labels must declare milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame. Sesame became the ninth major allergen under the FASTER Act, effective January 1, 2023.
Where undeclared allergens come from
- Wrong package. Product runs in film or cartons printed for a different SKU, often at changeover.
- Formula changed, label didn't. A reformulation or ingredient substitution never reached the label.
- Supplier change. A new ingredient source contains an allergen the old one didn't, and the specification wasn't reviewed.
- Cross-contact. Shared equipment wasn't cleaned to a validated standard between allergen profiles.
The pattern: most allergen recalls trace back to change, such as a new film roll, formula, supplier or product on the line. Control the change and you control most of the risk.
Controls that work
- Label verification at start-up and every changeover, checking the actual package against the production schedule, with a signed record.
- Packaging material control, segregating and reconciling printed packaging so obsolete or wrong film can't reach the line.
- Specification review on every supplier or ingredient change, including sub-ingredients.
- Change management that forces a label review when a formula changes.
- Validated allergen cleaning between profiles, verified with allergen-specific testing.
- Scheduling allergen-free products before allergen-containing ones where you can.
Want to know where your gaps are? The free Audit Readiness Scorecard includes labeling and allergen questions.