Quick Answer: FSMA Section 204 is the FDA Food Traceability Rule requiring enhanced traceability records for foods on the FDA Food Traceability List, including GS1 SSCC barcoding on pallets, with enforcement beginning January 20, 2026.
Detailed Answer
FSMA Section 204 (21 CFR Part 1, Subpart S) was finalized in November 2022 with enforcement starting January 20, 2026. The rule requires Critical Tracking Events (CTEs) and Key Data Elements (KDEs) for foods on the FDA Food Traceability List (FTL): leafy greens, certain fruits and vegetables, sprouts, fresh-cut, soft cheeses, finfish, crustaceans, ready-to-eat foods. Pallets carrying these foods need GS1 SSCC barcoding for unit-load identity, plus records of harvest, manufacture, transformation, and shipping events. Records must be kept 24+ months.
Authoritative Sources
- FDA FSMA Section 204
- 21 CFR Part 1 Subpart S
- GS1 SSCC
- FDA Food Traceability List
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