In the food industry, keeping abreast of—and complying with—international food safety regulations can feel like trying to hit a moving target. For food exporters with products destined for the U.S. market, staying ahead of the curve isn't just smart business—it's a matter of survival. Case in point: the United States’ final traceability rule outlined in the Food Safety and Modernization Act (FSMA) and the 2026 deadline for complying with it. Yes, even if you’re based outside of the US.
Getting up to speed (and up to snuff) with FSMA 204 can be a daunting task. It's also an opportunity to modernise your traceability practices and potentially gain a competitive edge in the U.S. market. If you export to the US, our recent webinar — Exporting to the US? What You Need to Know About the New Traceability Requirements — is for you.
It was designed to get non-U.S. companies that export food products to the country to give them the information they need to gain and maintain access to the U.S. market. Our expert panel, featuring Katy Jones, CEO of Trustwell, and Zoe Richards, International Business Solutions Director, provided invaluable insights for food exporters preparing for FSMA 204.
Did you miss the live webinar? No worries. You can access a recording of the session on-demand now — we'll even make sure you get a copy of Katy's slides. In the meantime, we've distilled the session into seven essential takeaways here.
7 Rules for Exporters for FSMA 204 Compliance
Key Takeaway: If you export certain food products to the US, you must comply with the final traceability rule outlined in section 204 of the Food Safety Modernization Act, otherwise known as FSMA 204.
- Exporters must know that FSMA 204 regulates food traceability to prevent foodborne illnesses and ensure swift recalls.
- Specific high-risk foods like fresh produce, cheese, seafood, and ready-to-eat products are included under FSMA 204.
- Compliance is mandatory for all businesses handling designated high-risk foods intended for US consumers.
- Enhanced traceability means tracking each step in the supply chain, including beyond your internal data to capture critical tracking events (CTEs) and key data elements (KDEs).
- Exporters must keep detailed, accurate, and standardised records for each CTE, and provide this data in a sortable spreadsheet within 24 hours upon request.
- Building strong relationships with suppliers and adopting advanced digital tools are crucial for meeting traceability requirements efficiently.
- Standardised data practices are essential first steps toward compliance with FSMA 204.
FSMA 204 is a Food Traceability Rule Authorised by the Food and Drug Administration in the US
FSMA 204 is shorthand for The Food Safety and Modernization Act, section 204, which details how all food that ends up on US consumers’ plates must be traced through the supply chain by 20 January 2026.
Read More: How FSMA 204 Impacts International Suppliers
As part of an ongoing effort to reduce foodborne illness outbreaks, the final traceability rule outlined in section 204 requires companies that manufacture, process, pack, or hold certain high-risk foods to capture and record data at specific points along the food supply chain. This data can then be made available to the Food and Drug Administration (FDA) if an outbreak occurs, providing greater visibility into the incident so that it can act quickly and precisely to mitigate its effects.
The Food Traceability List Includes Common Exports Like Seafood, Cheese & Produce
FSMA 204 does not apply to all food products intended for consumption in the US, just those on the Food Traceability List (FTL). The FDA has determined these foods to be "high risk" because they’re susceptible to contamination by bacteria like E. coli and Listeria. The FTL also includes foods that pose a "high risk" to specific populations, such as pregnant, immunocompromised, and elderly consumers.
Many of the listed items are top exports destined for the US from the UK or countries within the EU, such as meat, dairy products, and fresh fruit and vegetables. For instance, 9% of the UK’s £629 million in exported cheeses are bound for the US — and many are included on the FTL.
When Exporting Food to the US, FSMA 204 Compliance is Mandatory
If you export food to the US, knowing which of your products are on the FTL is essential because you’ll be expected to comply with the data capture and recordkeeping requirements outlined in the final traceability rule by 20 January 2026.
Watch Next: FSMA 204 Insights and the FDA’s Roadmap for 2024
FSMA 204 rules don’t mandate these requirements for all foods, but if your exported goods are on the FTL and fail inspection at ports of entry after FSMA 204 goes into effect, they could be subject to refusal of admission, among other penalties.
Enhanced Traceability Will Require Capturing Data for the Entire Food Supply Chain
Complying with FSMA 204 as an exporter will require collecting traceability data. Specifically, exporters must record Critical Tracking Events (CTEs) and Key Data Elements (KDEs). The seven CTEs represent key stages or milestones in a product’s movement through the food supply chain. 
Read More: Understanding Critical Tracking Events
Actions occurring at each of these stages will require the additional capture of KDEs. These are outlined for each CTE within FSMA 204 and help develop the granularity of your product’s traceability. They will require you to collect information about where and when the action took place, and which parties were involved, among other things.
Since these are specific to both the foods you export and the CTEs your exports undergo, it’s best to refer directly to the FDA’s resources if you are unsure what data you need to collect.
International FSMA 204 Compliance: Recordkeeping Requirements
When it comes to recordkeeping, the FDA requires a few things from exporters to be considered in compliance with the final traceability rule unless an exemption is applied:
- Traceability records must be maintained for 24 months
- These records must be legible and stored "to prevent deterioration or loss"
- If the FDA requests traceability records, you must provide them within 24 hours
- You must submit this information in an electronic sortable spreadsheet (ESS)
There’s no explicit requirement for digital recordkeeping in FSMA 204 — the FDA allows for original paper records or true copies alongside electronic ones — but it is easy to see why digitisation is smart practice here. Exporters who have not invested in digital recordkeeping and management may need to rethink their strategy and implement systems and tools that allow them to do so.
Strong Supplier Relationships are Critical to Achieving FSMA 204 Compliance
The nature of the data points that must be captured to comply with CTE and KDE requirements makes data sharing inevitable.
The webinar’s example of a tomato’s journey through the supply chain illustrates how an exporter could be responsible for recording information about a previous supply chain stage, such as when a received item was initially shipped and where it was shipped from.
When you export an FTL item, you will likely need to ensure more than just your own compliance with the traceability requirements for that item. You will need to ensure your suppliers' compliance, too. That makes comprehensive supplier management an absolute must, to say nothing of the strong supplier relationships and open communication that make it possible.
Invest in Data Standardisation for a Traceability Program That Goes Further Than FSMA
Data that has been standardised can be better utilised. When there is an outbreak of foodborne illness, the ability to act with as much speed and precision as possible is crucial to limiting the negative impact on public health. That need has driven traceability governance like FSMA 204, but investing in data standardisation has benefits beyond compliance.
Read More: GS1 for Food Traceability
Business cases for standardised data practices range from inventory reconciliation to more precise recall execution, representing significant cost savings and operational efficiencies. In an industry with a supply chain ecosystem as complex as the food industry, the ability to realize those benefits can be transformative.
Bonus Takeaway: Trustwell offers extensive resources and support to help exporters navigate and comply with these regulations
FSMA 204 is about more than just meeting regulations—it is an opportunity to improve supply chain visibility, reduce recall risks, and build trust with US consumers. Getting ahead of these requirements can really pay dividends for savvy food exporters.
Trustwell’s pioneering legacy was built on our ability to anticipate, understand, and create solutions for industry and regulatory change. Wherever you are on your compliance journey, we can meet you there. Our educational resources, consulting services, and comprehensive traceability technology can help you achieve compliance in time and stay ahead of future regulatory changes in your destination markets.
Contact one of our international traceability experts for help reviewing the Food Traceability List and determine whether the products you export to the U.S. are subject to FSMA 204. To discover how your company can capture, record, and store records with FoodLogiQ Traceability, book a personalized demo.
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