The legal baseline
Under the Food Allergen Labeling and Consumer Protection Act, packaged foods must declare the presence of major food allergens. The list comprises milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and — following the FASTER Act — sesame.
21 CFR Part 117 additionally requires food allergen preventive controls where a hazard analysis identifies an allergen hazard requiring a preventive control. Those controls typically address both label accuracy and prevention of allergen cross-contact during production.
The regulatory requirement is not the hard part. Very few companies misunderstand that peanuts must be declared. The failures are operational.
The four root causes we see repeatedly
Nearly every undeclared allergen event traces to one of a small number of process failures.
- A formulation or supplier change that did not trigger a label review — the most common pattern by a wide margin
- The wrong label or wrong packaging film applied at the line, often during a short run or a changeover
- Cross-contact from inadequate changeover cleaning, or from shared equipment that cannot be effectively cleaned between products
- Rework or scheduling decisions that introduce an allergen into a product not formulated to contain it
Label control is a food safety control
Treating labels as a marketing or packaging function is the structural error behind the first two root causes. Label artwork approval needs to sit inside the same change-control process as formulation and supplier changes, with a quality or food safety approval step that cannot be bypassed by a procurement decision.
Practical controls include a documented gate where any bill-of-materials change forces label review before production; reconciliation of labels issued, applied and destroyed at each run; and a line-clearance check at changeover that verifies the label on the line against the production order, recorded by a second person.
Where a supplier substitutes an ingredient, the risk is entirely invisible unless your supplier approval program requires notification of formulation changes and someone actually reviews those notifications against your labels.
Changeover validation, not changeover assumption
An allergen changeover procedure that has never been validated is a hypothesis. Validation means demonstrating, with evidence, that the specified cleaning removes allergen residue to an acceptable level on your equipment with your product — commonly through visual inspection combined with allergen-specific swab testing under representative worst-case conditions.
Some equipment cannot be validated to that standard. Where it cannot, the honest answers are dedicated equipment, dedicated lines, product sequencing so the allergen-containing product runs last before a full wet clean, or a label that accurately reflects the situation. Precautionary allergen labeling is not a substitute for a control where a control is achievable, and its use raises its own questions.
Finally, allergen risk assessment should be revisited whenever the product mix, schedule or equipment changes. An allergen matrix built two years ago against a product range you no longer run is documentation rather than control.
Primary sources
Go to the source rather than relying on this summary. Regulation text and agency guidance are the authority; this page is an interpretation of them.
- Food Allergen Labeling and Consumer Protection Act (FALCPA)
- FASTER Act — sesame as a major food allergen
- 21 CFR Part 117 Subpart C — food allergen preventive controls
- 21 CFR Part 101 — food labeling requirements