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FSMA 204 lot codes: does FDA require them on labels or barcodes?

, 6 minute read

No. FDA’s rule does not require the traceability lot code to appear on your food label or package, and the rule text does not call for a barcode or any specific format. What the rule requires is that you give the lot code to the next business in the chain, and that they can keep the records the rule asks for. A label is one way to do that. It is not the only way.

On timing: FDA has proposed moving the compliance date from January 20, 2026 to July 20, 2028. Congress also directed FDA not to enforce the rule before that date, and FDA says it intends to comply. Check FDA’s rule page for the current status. New to the rule? Start with FSMA 204 in plain English.

What does FDA say about labels?

FDA’s traceability lot code page says: “the final rule does not require that the TLC be included on food labeling or food packaging.” It also says the rule “does not prescribe a specific way firms must assign a TLC.”

So you pick the format. FDA gives examples of what can work, including “a Julian date, a lot code, batch code or other production code.” Whatever you pick must meet the rule’s definition of a traceability lot code, and your traceability plan must describe how you assign it. Our guide to assigning lot codes covers the choices.

What must you give the next business?

When you ship a listed food, 21 CFR 1.1340 requires two things:

  1. You keep shipping records linked to each lot.
  2. You give the immediate subsequent recipient (other than a transporter) seven of the data items, “in electronic, paper, or other written form.”

The seven items you pass on are:

  • The traceability lot code
  • The quantity and unit of measure
  • The product description
  • The location description of the recipient
  • The location description of where you shipped from
  • The shipping date
  • The location description of the traceability lot code source, or a reference to that source

The eighth item, the reference document type and number, goes in your own records. It is not part of what you must hand over. Our key data elements guide shows these items next to the other events.

The buyer then has their own job. Under 21 CFR 1.1345, they keep receiving records that include the lot code and the lot code source. If you leave the code off, they cannot do that. See what to do when a supplier does not send a lot code for the receiving side.

What ways can you pass a lot code along?

FDA says the lot code “could be sent to the next recipient of the food in a variety of ways.” Its page lists three:

  • A bill of lading
  • An advance shipment notice (ASN)
  • A separate email

FDA also says you can send it “by embedding the information in a quick response (QR) code” on the food’s packaging or on a related document. The information does not have to physically travel with the food. It does have to reach the buyer in a form that lets them keep the required records.

Ways FDA says a lot code can reach the buyer
  1. Bill of ladingLot code listed on the shipping paperwork
  2. Advance shipment noticeElectronic notice that carries the lot code
  3. EmailA separate message with the lot code
  4. QR codeEmbedded on the packaging or on a related document

Taken from FDA's traceability lot code page. Not a complete list.

What is a lot code source reference?

The rule asks for where the lot code was assigned. That is the traceability lot code source. If you would rather not print a full address on every shipment, you may send a source reference. The rule defines it as “an alternative method for providing FDA with access to the location description.”

FDA’s examples are “the FDA Food Facility Registration Number for the traceability lot code source” or a web address that gives FDA the location description. A web address can sit inside a QR code. Our post on the traceability lot code source walks through what to put in the record.

Why do some buyers still want it on the label?

Because the rule sets a floor. A buyer can ask for more. A retailer or distributor may write its own label and data requirements into a vendor agreement, such as case labels with a barcode or an ASN for each load. Those requirements would come from your customer, not from FDA. See why retailers want your traceability data.

A label also makes sense for plain practical reasons:

  • A lot code on the case lets a receiver key it in or scan it, instead of retyping it from a document.
  • It lowers the chance that one pallet gets matched to the wrong paperwork.
  • It helps you find a lot in your own warehouse during a mock recall.

If your buyer does not ask for a barcode, you can start with a printed lot code and a clear shipping document. If you do print a barcode, check with that buyer which format they want first. Do not assume one.

What if you make the lot code up as you go?

That is the trap. A label is only as good as the code printed on it. Check these before you print anything:

  • One lot, one code. The same food from the same lot should carry the same code in every record.
  • Consistent format. Mixed formats for the same product make your spreadsheet hard to sort.
  • Same code from supplier to shelf. If you receive a lot code from a supplier, pass it on. 21 CFR 1.1320 has you assign a lot code when you first pack a raw agricultural commodity, take in food from a fishing vessel on land, or transform a food. It says you must not create a new one during other activities, such as shipping. Our transformation records post explains one of those events.
  • Written in your plan. Your traceability plan must describe how you assign lot codes. Use our plan template as a start.

A short checklist

  • Decide your lot code format and write it into your traceability plan.
  • Decide how each customer gets the lot code: bill of lading, ASN, QR code, email or a label if they ask for one.
  • Send all seven shipping items to the recipient, including the lot code source or a source reference.
  • Keep your own shipping record, including the reference document type and number.
  • Ask each large buyer for their label and data rules in writing.
  • Test it. Pick one shipped lot and see how fast you can find every record for it.

Where Lotcrumb fits

Lotcrumb is being built to read the invoices, bills of lading and case labels a small food company already has, pull out lot codes and key data elements, and assemble the records when someone asks. It is not built yet. Join the waitlist.

This is general information about a federal food safety rule, not legal or regulatory advice. Check the current rule text and FDA guidance, and talk to a qualified food safety or legal professional about your situation.