FDA publishes final food traceability rule

November 28, 2022

FDA has published the final version of its regulation on “Requirements for Additional Traceability Records for Certain Foods.” The rule, pursuant to the regulatory mandates of the Food Safety Modernization Act, establishes additional traceability recordkeeping requirements for foods on the “Food Traceability List” (FTL). The compliance date for all companies covered by the rule is January 20, 2026. FDA will release further compliance guidance on this rule, including a compliance guide for small entities, before that date.

Under the rule, the creator or first receiver of foods on the FTL will be required to create a lot-specific “traceability lot code” for the food. This code will then follow the lot through the supply chain until a documented kill step is applied or the lot enters retail sale. Companies that ship, receive or transform the food throughout the supply chain will also be required to maintain additional records depending upon their operations. Food products containing ingredients on the FTL will be subject to the same traceability requirements up to the point of retail.

The category of “Herbs (fresh)” is included on the FTL; however, dried herbs are considered a separate commodity and are not directly subject to its requirements. Companies that perform herb drying may need to maintain additional records under the rule.

FDA will hold an informational webinar on the traceability rule (anticipated to be the first of several) on Wednesday, December 7, 2022, from 10am-2pm (Pacific), 1-5pm (Eastern). Interested parties can register for the webinar here.




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