A manufacturer's master case carries the full label: the product name, the ingredients and the allergen declaration. When you open that case and sell what is inside in smaller units, or repack the product into your own packages, that information does not travel by itself. Whether the smaller unit is properly labeled is now a question about your warehouse, not the manufacturer's.

What the law requires on the label

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) named eight major food allergens: milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat and soybeans. The FASTER Act, signed on April 23, 2021, added sesame as the ninth, with labeling required from January 1, 2023 (FDA, Food Allergies).

  • How it is declared. Either in parentheses after the ingredient, such as "whey (milk)", or in a "Contains" statement immediately after or next to the ingredient list, such as "Contains wheat, milk, and soy."
  • Specifics. The label must name the type of tree nut (almonds, pecans, walnuts), and the species of fish and Crustacean shellfish (cod, shrimp, crab).
  • Who it applies to. Most packaged foods the FDA regulates. The FDA says the requirements extend to retail and foodservice establishments that package, label and offer products. They do not apply to food placed in a wrapper or container in response to a customer's order at the point of purchase.
  • What is outside FALCPA. Meat, poultry and egg products (regulated by USDA), raw agricultural commodities and highly refined oils, among others.
  • "May contain" statements are voluntary. They are not a substitute for declaring an allergen that is an ingredient.

The stakes are real. The FDA reports that from September 2009 to September 2014, about one-third of foods reported through its Reportable Food Registry as serious health risks involved undeclared allergens. For the detail on labeling, the FDA publishes a question-and-answer guidance on allergen labeling.

Where the trap is

A case break is not one situation but three, and they carry different risks.

  1. Inner units that are already fully labeled. A case of individually labeled retail packs. Selling the packs one at a time keeps the manufacturer's label on each. The check is simple: confirm each inner unit really carries the full label, not just a product name and a barcode.
  2. Inner units without a full label. Bulk-pack bags, unlabeled trays or portions where only the master case carries the ingredient and allergen statement. Sell one of these by itself and the food leaves your building without its declaration. This is the trap.
  3. Repacking. Cutting a block of cheese, portioning, or weighing product into new packages under your own label. You are now creating a packaged food, and the new package needs the label information any packaged food needs, including the allergen declaration.

Mixed or assorted packs need extra care: the declaration has to cover everything in the pack.

Get the data right before the first break

  • Keep the allergen statement on the item record, copied from the manufacturer's label or specification sheet, with the date it was checked. Do not retype it from memory.
  • Treat "none" as a value. An item with no major allergens should say so explicitly, so a blank field always means "not yet checked".
  • Link the broken unit to its master case item, so the smaller unit inherits the statement instead of carrying its own copy that can drift.
  • Re-check on any change of supplier or brand. A substitute product from another manufacturer can have different ingredients under the same description.
  • Flag items whose inner units are not fully labeled, so the people breaking cases know which ones need a label.

Build the rule into the workflow

  • A label template for broken and repacked units that always prints the allergen statement, along with the other core elements of a packaged food label, such as the product name, net quantity, ingredient list, and the name and place of business of the manufacturer, packer or distributor.
  • A hard stop: if the allergen field is blank, the label does not print and the break does not proceed.
  • A second check on the first break from each new lot: someone compares the printed label against the master case label.
  • A record of each break: which lot was opened, when, by whom, how many units came out, and which label version was printed. If the product is on the FDA's Food Traceability List (soft cheeses are, for example), repacking also counts as a transformation under FSMA 204, with its own records. See what critical tracking events mean for your software.
  • Separation in the repack area, so allergen-containing products do not come into contact with products that are not supposed to contain them. If your facility is subject to the FDA's preventive controls rule, that rule includes allergen controls; your food safety plan should cover them.

For what else to track when you break cases, see the case-break workflow.

If a unit ships without its declaration

Find every lot and customer affected, contact those customers, and talk to your supplier and your regulatory advisor about whether a recall is needed. The FDA considers a food missing a required allergen declaration misbranded and subject to enforcement such as a recall, so act on the same day you find it. Your lot tracking decides how fast you can name the customers.

How APFoodz handles it

In APFoodz you design your own case labels and print them to a Zebra or any other printer (see labels and printing), and each lot's events are recorded as the work happens, so the customers who received a lot are a lookup.