FDA Finalizes Food Traceability Rule 204 - What that means for the food supply chain

Part of the Food Safety Modernization Act (FSMA) included the requirement to improve and implement traceability within the food supply chain. The requirement, FSMA Section 204, gave the FDA the authority to create a list of food items that require additional recordkeeping and to establish what those recordkeeping requirements are. On November 7, 2022, the FDA announced that it had finalized both the Food Traceability List and the recordkeeping requirements.

This announcement is the beginning of a transition to tech-enabled traceability - with the goal of improving food safety across the global supply chain. FSMA Section 204 requires that companies involved in the manufacturing, distribution, and sale of foods on the Food Traceability List maintain Key Data Element (KDE) records for Critical Tracking Events (CTEs). In layman’s terms, that means capturing information such as product and batch/lot at key points as it moves throughout the supply chain.

The Food Traceability List currently includes 16 of the highest risk fresh food categories. Supply chain partners associated with any of the thousands of SKUs impacted by the Food Traceability List will be required to capture and maintain end to end traceability of these products - from farm to store.

While FSMA 204 requires data capture that is much broader than simply a food item and its expiration date, the utilization of barcodes and/or RFID will be transformational for the food industry. Since 1987, we have been the chosen compliance partner for thousands of organizations. Here at GMP Labeling, we have the expertise to help your organization remain compliant as FSMA 204 rolls out to the industry. Whether that means helping to identify traceability software, purchasing printers, barcode labels, thermal transfer ribbons, and/or barcode scanners - we are here to support you through this industry transformation.