FSMA 204¶
The FDA's Food Traceability Rule requiring enhanced tracking for high-risk foods.
What is FSMA 204?¶
FSMA Section 204 (also known as the Food Traceability Rule) is a U.S. Food and Drug Administration regulation that requires additional traceability recordkeeping for certain high-risk foods.
The rule aims to enable faster identification and removal of contaminated foods from the market, protecting public health and reducing the impact of foodborne illness outbreaks.
Compliance Deadline¶
January 20, 2026
The compliance deadline has passed. Entities subject to the rule are now expected to be in full compliance.
Foods on the Traceability List (FTL)¶
The rule applies to foods designated on the FDA's Food Traceability List, including:
| Category | Examples |
|---|---|
| Leafy greens | Lettuce, spinach, kale |
| Fresh-cut produce | Fresh-cut fruits and vegetables |
| Fresh herbs | Basil, cilantro, parsley |
| Vegetables | Tomatoes, peppers, cucumbers, sprouts |
| Fruits | Melons, tropical tree fruits |
| Seafood | Finfish (including smoked), crustaceans, molluscan shellfish |
| Other | Ready-to-eat deli salads, nut butters, fresh and soft cheeses, shell eggs |
Key Data Elements (KDEs)¶
The rule requires tracking specific data at Critical Tracking Events (CTEs):
Traceability Lot Code¶
A unique identifier assigned to a lot of food for traceability purposes.
Product Description¶
Including product name, variety, and brand name.
Location Identifiers¶
Where the food was grown, received, transformed, or shipped.
Date Information¶
Harvest dates, ship dates, and receive dates.
How GS1 Standards Help¶
GS1 identifiers and data carriers are well-suited for FSMA 204 compliance:
- GTIN -- Identifies the product
- Batch/Lot (AI 10) -- Captures the traceability lot code
- Serial Number (AI 21) -- Enables item-level tracking when needed
- GLN -- Identifies locations in the supply chain
- GS1 Digital Link -- Encodes all this data in a scannable 2D code
How GTIN1 Enables FSMA 204 Compliance¶
GTIN1 provides the digital infrastructure you need to meet FSMA 204 requirements efficiently:
Lot-Level QR Codes¶
Generate GS1 Digital Link QR codes that encode both GTIN and lot number (AI 10). Each code uniquely identifies the product and its traceability lot code in a single scan.
Date Tracking¶
Encode harvest dates, production dates, and expiration dates directly in your Digital Links using GS1 Application Identifiers (AIs 11, 13, 15, 17).
Serial Number Support¶
For item-level traceability, generate unique serial numbers (AI 21) at scale. Track individual units through the supply chain when required.
Recall Management¶
When a recall is needed, instantly flag affected lots. Consumers scanning the QR code see recall alerts immediately -- no waiting for news coverage.
Manufacturing API¶
Integrate GTIN1 directly with your production line. Generate lot codes and QR labels in real-time as products are packaged, ensuring accurate traceability from day one.
Audit-Ready Records¶
Maintain digital records of all lots and serials created. Export data for FDA inspections or internal audits with complete traceability history.
GTIN1 FSMA 204 Workflow¶
- Register Products -- Add your FTL products to GTIN1 with their GTINs
- Create Lots -- Generate traceability lot codes for each production run
- Print Labels -- Generate QR codes with GTIN + lot encoded
- Track & Respond -- Monitor scans and push recalls when needed
Beyond Compliance
While FSMA 204 focuses on traceability records, GTIN1's Digital Link approach adds consumer value. The same QR code that enables compliance also lets consumers access product information, allergen data, and freshness details -- turning a regulatory requirement into a customer experience advantage.
Prepare for FSMA 204
GTIN1 supports batch/lot and serial tracking to help you meet traceability requirements.