FSMA 204 with DNV

FDA FSMA 204 and what this means for you

The FDA has established additional traceability record keeping requirements. The rule, “Requirements for Additional Traceability Records for Certain Foods” (Food Traceability Proposed Rule) is a key component of the FDA’s New Era of Smarter Food Safety Blueprint and would implement Section 204(d) of the FDA Food Safety Modernization Act (FSMA). At the core of this proposal is a requirement for those who manufacture, process, pack or hold foods on the Food Traceability List (FTL) to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs). Source:FDA

The list of food categories ranges from seafoods to fresh produce, and the FTL categories are certain cheeses, shell eggs, nut butter, finfish, crustaceans, mollusks, ready-to-eat deli salads including a list of fresh produce such as cucumbers, herbs, leafy greens, melons, peppers, sprouts, tomatoes, tropical tree fruits. This list is likely to be expanded in future.

What data is needed

At a very high level, the key data elements (KDEs) associated with critical tracking events of data pertains to data from:

• Harvesting
• Cooling
• Initial Packing
• First Land-Based Receiver
• Shipping
• Receiving
• Transformation

Dates for compliance with FSMA

The final rule is effective 20 January 2026

In addition, the proposed rule would also require that:

Traceability records be provided to FDA as soon as possible but no later than 24 hours after a request is made.

DNV: An unmatched partner for FSMA compliance

DNV is a solution provider with decades of experience within assurance, food safety certification and risk management within the food industry. DNV provides certifications to all GFSI standards, 2nd party & supply chain verification, and audits enhanced by our digital solutions in supply chain traceability and transparency.