FSMA 204 Traceability Rule

Initial Scoping and Readiness Assessment

The latest FSMA 204 rules on traceability will be enforced from January 2026.

You’ll need to ensure that all the necessary measures are in place for monitoring the origin, condition, location, and controls in time for the implementation deadline.​ All stakeholders are required to assess their readiness.

Initial Scoping Workshop

If you’re not sure how the rule applies to you and your products, our Initial Scoping Workshop will guide you. The one-hour session, held virtually, will be followed by a Q&A session and includes:

  • Review of ingredients and finished products, compared to FDA’s Food Traceability List.
  • Document check (e.g. Traceability Plan).
  • Check that all relevant stakeholders covered by the rule have been captured.
  • Access to a 30-minute video recording, explaining the principles of FSMA 204 traceability requirements.

We’ll review your product list and explain whether the rule applies to you. We’ll recommend whether you need a more thorough Readiness Review.

FSMA 204 Readiness Assessment

If you already know your products are in scope, you can opt to go straight for the full Readiness Assessment. We’ll meet at your premises to review your Food Safety Plan for traceability, record keeping, and crisis management.​

We’ll first run a one-hour presentation, explaining in-depth the principles of FSMA 204 traceability requirements.

For complete peace of mind, our expert consultant will review your processes and documentation to ensure you comply. The assessment will:

  • Review your Food Safety Plan – including records of Key Data Elements (KDEs) for any Critical Tracking Events (CTEs) that occur at the facility.
  • Identify any exemptions that apply.
  • Make recommendations for updating documentation and introducing measures to record KDE’s and CTE’s (if required).
  • Check your Traceability Plan or advise on how to create one.

We’ll work to identify whether you need any additional support based on our exploratory conversations. If necessary, we’ll prepare an overview of next steps.

The new rule establishes traceability recordkeeping requirements beyond those in existing regulations. It applies to anyone who manufactures, processes, packs, or holds foods included on the Food Traceability List (FTL) – with some exceptions.

Enforcement of the rule begins on January 20, 2026, with routine inspections starting in 2027. Our experienced consultants can guide you, to ensure you understand the requirements and comply.

Matt Taylor
Senior Global Manager, Consulting, NSF

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