Canadian companies in supply chains responsible for foods exported to the United States (U.S.) are reminded that the compliance date of the U.S. Food and Drug Administration's (FDA) Food Traceability Final Rule (FSMA 204) is January 20, 2026.
The rule, published as Section 204 of the Food Safety Modernization Act (FSMA) by the U.S. FDA, also applies to food businesses not located in the U.S.
Purpose of the rule
FSMA 204 will enable faster identification and removal of potentially contaminated foods from the market, resulting in fewer foodborne illnesses and deaths. The rule requires additional traceability information (Key Data Elements) to be maintained for important activities (Critical Tracking Events) in the supply chain for Food Traceability List listed foods.
As of January 20, 2026, upon request, food businesses must be able to provide the required traceability information to FDA within 24 hours in an electronic sortable spreadsheet.
Food Traceability List
Foods subject to additional traceability requirements appear on the FDA's Food Traceability List (FTL), which includes the following foods and foods containing these ingredients:
- fresh fruits and vegetables (for example: cucumbers, peppers, tomatoes, melons, tropical tree fruits, leafy greens, herbs, and sprouts)
- fresh-cut fruits, vegetables, and leafy greens (all types)
- soft and semi-soft cheeses
- finfish (fresh, frozen, previously frozen, and smoked)
- crustaceans and molluscan shellfish (fresh, frozen, previously frozen)
- ready-to-eat deli salads (refrigerated) (for example: salads with leafy greens or cut fruit, egg salad, tuna salad, potato salad, and pasta salad)
- nut butters
- shell eggs
Who this rule affects
Impacted Canadian businesses include growers, packers, cooling and storage facilities, distributors, shippers, receivers, manufacturers, and processors. Canadian retailers and restaurants are impacted if they distribute products to the U.S.
Enforcement
Failure to comply with the requirements of the rule will lead to enforcement by the FDA and could jeopardize your ability to prepare food for the U.S. market or export foods to the U.S.
Next steps
FDA recommends that food businesses start working immediately with their supply chain partners both in the U.S. and abroad so that they are well prepared to comply with the rule. For most food sectors, compliance with the rule will require significant whole supply chain changes to logistics, labelling, record keeping, and data sharing.
Resources
More information and guidance can be found on the FDA website. The Technical Assistance Network (TAN) is the single point of contact at FDA for questions related to FSMA 204.