Adopted, Applies Later Checked October 24, 2026
The compliance date was extended from January 20, 2026, to July 20, 2028.
Next: July 20, 2028: Key Data Elements for each Critical Tracking Event become enforceable.
What It Covers
Additional traceability records for foods on the Food Traceability List, so that FDA can trace contaminated food quickly.
Who It Applies To
Persons who manufacture, process, pack or hold foods on the Food Traceability List, with exemptions set out in the rule.
Key Requirements
- A traceability plan describing procedures, the traceability lot codes, and a point of contact.
- Key Data Elements recorded for each Critical Tracking Event, such as harvesting, receiving, transformation, and shipping.
- Traceability lot codes assigned at defined events.
- An electronic sortable spreadsheet provided to FDA within 24 hours on request.
What an Auditor Asks to See
- The traceability plan, and the records for a lot from receipt to shipment.
Where Systems Fall Short
- Lot codes that change at each step with no link to the previous one.
How QES Helps
Traceability plans and record systems ready well before July 2028.
Related Standards
Sources. US FDA — FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods (opens in a new tab); eCFR — 21 CFR Part 1 (opens in a new tab). Status checked October 24, 2026. This page summarizes FSMA 204 · 21 CFR Part 1, Subpart S; it does not reproduce or replace it. Buy the standard from its publisher, or read the regulation in its official text, before relying on a detail. Not legal advice.