21 CFR 1 Subpart L
Requirements for Additional Traceability Records for Certain Foods · fsma 204 · food traceability rule · fstr · subpart l · 21 cfr 1 subpart l
FSMA Section 204 — the Food Traceability Rule. From 20 July 2028, anyone who manufactures, processes, packs, or holds a Food Traceability List item must keep Key Data Elements for every Critical Tracking Event and produce them to FDA within 24 hours.
21 CFR Part 1 Subpart L implements Section 204 of FSMA. It applies to any person who manufactures, processes, packs, or holds foods on the Food Traceability List (FTL) — leafy greens, fresh-cut fruits and vegetables, sprouts, melons, fresh herbs, fresh tropical fruits, shell eggs, nut butters, fresh and frozen finfish and crustaceans, ready-to-eat deli salads, soft and semi-soft cheese, and others. For each Critical Tracking Event (CTE) — harvesting, cooling, initial packing, shipping, receiving, transformation — the firm must capture defined Key Data Elements (KDEs) including the Traceability Lot Code (TLC), reference document identifiers, dates, quantities, and location identifiers (in many cases including geo-coordinates).
The records must be kept for two years and produced to FDA in a sortable electronic spreadsheet (CSV or Excel) within 24 hours of request — paper or PDF do not satisfy the rule. The original 20 January 2026 compliance date was extended by 30 months on 5 March 2025; the new compliance date is 20 July 2028. Importers of FTL foods are also covered; this dovetails with FSVP (21 CFR 1 Subpart L is a different subpart from FSVP's Subpart L of Part 1, despite the share — verify the citation against the section you mean).
- 21 CFR Part 1 Subpart L
- 21 CFR 1.1305
- 21 CFR 1.1310
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