21 CFR 1 Subpart S · Food Traceability List · Key data elements
FSMA 204 records kept as you ship, receive and transform, with scope decided by your people.
Keep lot codes, quantities, dates and references as you ship, receive and transform. Your qualified people decide whether the rule applies and how.
UltimateFree guide
FSMA 204 Scope & Key Data Elements Worksheet
Questions for your qualified people on whether the traceability rule applies, and a worksheet of key data elements for shipping, receiving and transformation.
Free guide · 3 pages- PL-0142Picked300 units of Product A for Customer A, lots in expiry order
- GS1-128LabelledPallet Label Carries Product, Lot and Quantity
- BOL-0142ShippedSH-0142 shipped 14 Oct 2026 with three lots on the bill of lading
- Lot traceOn recordLot P-0142 back to its materials and forward to both customers
People pick, ship and decide. V5 keeps the lot on every record.
Conceptual illustration · fictional example
Does the rule apply, and which records would it need?
Three questions to discuss with your qualified people, then the key data elements the rule lists for each event. Fictional example: names, lots, dates and quantities are illustrative.
Answer the questions to see what to take to your adviser.
Key Data Elements by Event
21 CFR 1.1340(a)
- Traceability lot code
- Quantity and unit of measure
- Product description
- Location description of the immediate subsequent recipient (other than a transporter)
- Location description of where you shipped from
- Date shipped
- Traceability lot code source location, or its reference
- Reference document type and number
Fictional example record
- Lot code
- P-0142
- Quantity
- 120 units
- Product
- Product A
- Recipient
- Customer A, receiving location
- Shipped from
- Your site
- Date
- 14 Oct 2026
- Reference
- BOL-0142
Conceptual illustration · fictional example
Orientation only, not legal advice. 21 CFR Part 1 Subpart S, eCFR checked 29 Sep 2026.
Traceability records kept, not assembled.
A comparison of how the work is done, not a measured result.
UltimateFree guide
FSMA 204 Scope & Key Data Elements Worksheet
FSMA 204 Scope & Key Data Elements Worksheet
Questions for your qualified people on whether the traceability rule applies, and a worksheet of key data elements for shipping, receiving and transformation.
- Scope questions
- Key data elements by event
- Worked shipping example
- Dates and record requests
Full product detailCommon problems, what's included, why teams choose it, and where commercial meets regulated.
Traceability records scattered across receiving paperwork and spreadsheets.
Lot codes, quantities and dates recorded in different places for each event
Transformation records do not show which input lots made which output lot
Nobody has written down which foods and events the rule covers, and why
Records would have to be assembled by hand if FDA asked for them
What V5 records, and what your team decides.
Lots at Receiving
Material lots, quantities, dates and supplier are recorded at receipt.
Inputs to Outputs
Work orders record the input lots and quantities used for each finished lot.
Lots at Shipping
Shipments record lots, quantities, customer, date and bill of lading.
Lot Trace Reports
Trace a lot forward or back from the kept records.
Scope is yours
Which foods and events the rule covers, and any exemption, is decided and documented by your qualified people.
Exchange with Partners
Integrations are configured. EPCIS or a specific FDA spreadsheet export is not claimed here; confirm your need with us.
What V5 keeps for you.
- Lot, quantity and date on receipts, work orders and shipments
- Input lots linked to each finished lot
- Bills of lading and pick lists with their lots
- Lot trace reports forward and backward
The rule, in brief (checked 29 Sep 2026).
Scope · 21 CFR 1.1300
Applies to persons who manufacture, process, pack or hold foods on the Food Traceability List, with exemptions and partial exemptions. Your qualified people decide whether and how it applies.
Key data elements · 21 CFR 1.1340, 1.1345, 1.1350
Shipping, receiving and transformation each have listed key data elements, such as the traceability lot code, quantity and unit, product description, locations, date and reference document.
Record requests · 21 CFR 1.1455(c)
Records available within 24 hours of an FDA request, or a reasonable time FDA agrees to. An electronic sortable spreadsheet is required only in the circumstances the rule sets out, unless an exemption applies.
Dates
Original compliance date January 20, 2026. A 30-month extension to July 20, 2028 is proposed, not final; Congress directed FDA not to enforce before that date and FDA intends to comply.
FSMA 204 and V5, answered.
When is FSMA 204 compliance required?
The original compliance date was January 20, 2026. FDA has proposed extending it by 30 months to July 20, 2028; the proposal is not a final rule. Congress directed FDA not to enforce the rule before July 20, 2028, and FDA says it intends to comply. Check FDA's current pages before relying on any date.
Does the rule apply to us?
It depends on whether you handle foods on the Food Traceability List, which critical tracking events you perform, and whether an exemption applies. Your qualified people and advisers decide; V5 does not make that determination.
What is a traceability lot code?
A code identifying a lot of a listed food. It is assigned at initial packing of a raw agricultural commodity (other than food from a fishing vessel), first land-based receiving of food from a fishing vessel, or transformation, and in some receiving cases from a supplier the rule does not cover. Check 21 CFR Part 1 Subpart S for the exact conditions.
Does V5 produce the sortable spreadsheet?
V5 keeps lot trace reports and the records behind them. A specific FDA sortable spreadsheet export is not claimed here; confirm your need with us.
Does using V5 make us compliant?
No software does that on its own. V5 keeps records; your team owns the traceability plan, procedures and decisions.
Capabilities vary by plan and setup. Confirm specifics with our team before relying on them.
Talk through your FSMA 204 records.
Bring one food and its events and we will show which records V5 keeps.