The aim of this article is to introduce to the reader the new traceability regulation dictated by the FDA and its objective. Today, many food producers and/or distributors are not aware that there is a deadline, January 2026, to apply traceability in their supply chain.
The FDA Food Traceability Final Rule aims to establish additional traceability recordkeeping requirements for certain foods to help prevent foodborne illness outbreaks and facilitate more efficient tracking and tracing of food products during a foodborne illness outbreak investigation. The rule focuses on improving traceability for high-risk foods that are frequently associated with foodborne illness outbreaks and have a higher likelihood of being contaminated.
By January 2026, persons who manufacture, process, pack, commercialize, or hold foods included on the Food Traceability List (FTL) will need to record and save information, called Key Data Elements (KDEs), and share it with their clients or value-chain partners through each step of the chain, called Critical Tracking Events (CTEs).
All of the information recorder will need to be related to a Traceability Lot Code (TLC) in order to trace each batch of production and link each product with its information (KDEs). Requiring documentation of traceability lot codes and traceability lot code sources enables FDA to identify the source of the food faster by enabling FDA to skip steps in the supply chain, link a food to the firms that have handled it, and ultimately lead FDA back to the source of the food during an outbreak investigation.
In addition, companies will need to develop a traceability plan. The purpose of this document is to help stakeholders understand how to search and interpret information recorded, and how TLCs are assigned to batches. Furthermore, companies must introduce a point of contact in the document to answer questions about the traceability plan and records. Finally, agricultural or aquaculture companies must add a map of the field or containers where they grow the crops or the seafood, including geographic coordinates.