Allergens

Allergen Control and Labeling Compliance

Preventing undeclared allergens through cross-contact controls, accurate labeling and the written allergen control plan.

What this course covers

Few food safety failures are as preventable, or as common, as an undeclared allergen. US law recognizes nine major food allergens, milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame, the last of which was added under the FASTER Act effective January 2023. For any of these present as an ingredient, there is no safe threshold. It must be declared.

The risk often enters through cross-contact, the unintentional transfer of an allergen to a food that is not supposed to contain it, whether through shared equipment, surfaces, or something as simple as airborne flour dust. Preventing it takes deliberate controls: scheduling allergen-free products ahead of allergen-containing ones, separating equipment or lines where risk and volume justify it, and validating that cleaning between changeovers actually removes allergen residue rather than just visible soil.

Once an allergen is controlled on the line, it has to be communicated accurately on the label. The Food Allergen Labeling and Consumer Protection Act requires major allergens to be named in plain language, either within the ingredient list itself or in a separate "Contains" statement. Advisory phrases like "may contain" are voluntary and are never a substitute for controlling cross-contact in the first place.

This course ties these pieces together through the written allergen control plan required under Part 117: ingredient review, label verification, and the monitoring and corrective action that keep the plan more than a document on a shelf. It closes with the numbers that make this topic matter, undeclared allergens are consistently the leading cause of food recalls in the United States, most often traced back to a label changeover that did not happen or a rework batch that was not accounted for.

Who this course is for

What you'll learn

Why it matters

Undeclared allergens are consistently the leading cause of food recalls in the United States, most often traced back to a label changeover that did not happen or a rework batch that was not accounted for.

Regulatory sources

Related

Included in the full GMPify subscription

Completion certificate, PDF slide download, and access to the complete GMP course library from day one.

Start this course →