FSMA 204 transformation records: what counts and what to keep

Under the FDA Food Traceability Rule, transformation means manufacturing, processing or changing a food on the Food Traceability List. If you do that, you assign a new traceability lot code and keep a set of records that tie the lots you used to the lot you made. Repacking and relabeling count. Moving boxes around a warehouse does not.

The rule defines transformation in 21 CFR 1.1310 as an event that involves manufacturing or processing a food, or changing a food (for example by commingling, repacking or relabeling), when the output is a food on the list. The initial packing of a food, and activities before it, such as harvesting and cooling, are not transformation.

FDA has proposed moving the compliance date from January 20, 2026 to July 20, 2028, but had not finalized that change at the time of writing. Separately, Congress directed FDA not to enforce the rule before July 20, 2028, and FDA says it intends to comply. Check FDA’s rule page for the current date. New to the rule? Start with FSMA 204 in plain English.

What counts as transformation?

The test has two parts: you changed or made a food, and the result is on the Food Traceability List. FDA’s February 2026 draft Q&A guidance gives these examples. It is nonbinding draft guidance, so check for the final version.

• Repacking. FDA’s example is a pallet of tomatoes sorted and repacked by ripeness. The repacker becomes the lot code source, and in most cases a new lot code is assigned. FDA notes the repacker could keep the same code when repacking within the same lot, “like into like.”
• Relabeling. Relabeling is transformation even if the food is not repacked. FDA’s example is changing a brand name on the labeling.
• Culling during repacking. If removing poor-quality produce is part of repacking, the transformation records apply.
• Processing. Under the 21 CFR 1.1310 definition, manufacturing or processing, such as cutting, mixing or cooking, is transformation if the new food is on the list.

What does not count?

Per the same draft guidance:

• Breaking a pallet or case to send a case or an item to a customer is not transformation by itself. The lot code does not change.
• Stickers for internal tracking on cases, or a pallet license plate, are not relabeling.
• Culling outside of repacking. If the quantity in a lot drops because you removed bad product, but you did not repack it, you record the difference in your receiving and shipping records. It is not a transformation event.
• Making a food that is not on the list. Transformation requires a listed food as the output. FDA’s example is whole fresh papayas processed into fresh-cut papaya and then, right away at the same site, into frozen chunks. That is one processing event with a non-listed result, so you keep receiving records only.

What records do you keep?

21 CFR 1.1350 asks for records for each new lot you make. For the listed foods you used as inputs, if any:

• The traceability lot code
• The product description
• The quantity and unit of measure used from each lot

For the food you produced:

• The new traceability lot code
• The location where it was transformed, and the lot code source reference if applicable
• The date transformation was completed
• The product description
• The quantity and unit of measure
• The reference document type and number for the transformation event

You assign the new lot code under 21 CFR 1.1320, which requires one whenever you transform a food. The same section says you must not create a new lot code for other activities, such as shipping. For how to build codes, see traceability lot codes: how to assign them.

Retail food establishments and restaurants are not covered by these transformation records for food they do not ship, such as food sold or sent directly to consumers.

What if a process has several steps?

For continuous processing, FDA’s draft guidance says to look at the food at the start and the food at the end. Intermediate foods that exist only briefly inside one continuous process do not need their own records. If the nut butter you make is only a step toward a confection made right away at the same site, you do not record the nut butter as an ingredient. If you make nut butter as its own product and use it later, you do.

What about exempt inputs and kill steps?

If you receive an exempt food and turn it into a listed food that is not exempt, you keep records for the food you produced. FDA’s examples are raw oysters, which are generally exempt, becoming breaded raw oysters, which generally are not. The input records are not applicable when the input was exempt.

If you apply a kill step to the food, you may be exempt from transformation and shipping records under 21 CFR 1.1305(d)(3), but you must keep a record of the kill step. See FSMA 204 exemptions for the conditions.

A quick self-check

1. List each activity at your site that changes a product: repacking, relabeling, cutting, mixing, cooking.
2. For each, ask whether the output is on the list.
3. For each yes, confirm you capture input lot codes and quantities, the new lot code, the date and the document reference.
4. Make sure the new lot code can be traced back to every input lot, since FDA’s rule page says it can ask for records within 24 hours. See the 24-hour sortable spreadsheet.
5. Write the rules into your traceability plan.

Where Lotcrumb fits

Lotcrumb is being built to link input lots to the new lot you make when you repack, relabel or process a food, using the paperwork you already have. Join the waitlist for early access.

This guide is general information, not legal or regulatory advice. Whether an activity is transformation depends on the facts, so confirm yours with FDA’s guidance or a food safety professional.