Each year in the US, approximately 48 million people are affected by foodborne illnesses, resulting in some 128,000 hospitalizations and 3,000 deaths. These figures form a significant public health burden but are largely preventable with appropriate traceability measures. 

With the latest updates to the Food Safety Modernization Act (FSMA 204), the FDA aims to dramatically improve food safety in the US by shifting the focus to preventing foodborne illnesses by enhancing data-driven transparency and accountability within the food system. 

With the final implementation deadline set for 20th January 2026, organizations have a significant opportunity to align FSMA 204 compliance with the global industry move to 2D barcodes at the point-of-sale. By integrating these two initiatives, not only will brands stand to streamline changes and avoid additional interruption, but they can extend the benefits of traceability beyond mere compliance.

FDA Traceability Rule FSMA 204

Section 204 of the FDA Food Safety Modernization Act adds traceability record-keeping requirements for businesses that manufacture, process, pack or hold certain high-risk food products. 

FSMA 204 affects any business that handling food items covered under the Food Traceability List, including: 

  • Cheeses
  • Fresh, unprocessed eggs 
  • Nut butter
  • Fresh fruits and vegetables
  • Fish and shellfish 
  • Ready-to-eat deli salads 

Under the legislation, non-U.S. companies handling products for final consumption in the U.S. will also have to follow the same traceability requirements as companies located in the U.S. The U.S. currently imports roughly 15% of its overall food supply, including 32% of its fresh vegetables, 55% of its fresh fruit and 94% of all seafood consumed yearly. 

What Does FSMA 204 Stipulate?

FSMA 204 specifies the need for businesses to maintain and process data relating to Critical Tracking Events (CTEs) that reflect stages within the supply chain most at risk of incurring food safety incidents. These stages encompass everything from the initial harvesting of raw produce to the point at which a final, consumer-ready product is received for sale, for example, at a grocery store or retailer. 

In tracking CTEs, businesses can more readily identify the source of contamination, food safety or quality issues that may arise during a product’s journey from farm to fork and respond quickly and efficiently when an incident is identified. 

Businesses will be mandated to keep records containing Key Data Elements (KDEs) to track CTEs effectively. While the exact information will vary from case to case, traceability lot codes will form the foundation of the proposed requirements, helping to identify foods as they move through the supply chain.

Impacted organizations will need to put systems in place to collect and share data at key points throughout their supply chains and store records for two years following the sale or distribution of a food item. All traceability information must also be made accessible to the FDA, in electronic format, where required, within 24 hours of being requested. Non-compliance can have consequences that range from civil action all the way up to criminal prosecution.

FSMA 204 officially took effect in January 2023. Affected organizations have been given a three-year window to meet the requirements, with a deadline of 20th January 2026. This extended timeline is designed to allow for thorough preparation and implementation of traceability solutions across the supply chain.

Preparing for Compliance with FSMA 204

Companies can ensure that their traceability recordkeeping adheres to FSMA 204 guidelines by collecting all necessary KDEs and capturing the data as part of wider coding and marking efforts. 

The first step will be to identify gaps in data capture across the supply chain and work with supply chain partners to record the necessary data. Data recording will require multiple systems to communicate, so companies will need to consider coding and marking systems that allow for interconnectivity with other equipment to systematically track and record data across the supply chain.

The next step will be to ensure that the final consumer product can be tied back to the data required by the FDA using variable data printing. Companies already adding variable data onto products and packaging, such as date codes, may only need a small change to their current coding and marking setups to include batch and lot information. One suggested way this variable data element can be implemented is through a scannable 2D code, such as a QR code powered by GS1. 

Aligning FSMA 204 with a Move to 2D Barcodes at the Point-of-Sale 

While a scannable code is not a requirement of the FSMA 204, it offers significant opportunities to unlock additional benefits facilitated by enhanced traceability. Companies who look to incorporate FSMA traceability data within a QR code powered by GS1 can align FSMA compliance with the industry move to 2D barcodes at the retail point-of-sale. 

By aligning these two initiatives, companies can avoid the risk of having to make additional changes further down the line—but the benefits extend far beyond mitigating two sets of technology integrations. 

Machine-readable 2D codes are more resilient to damage or degradation through the supply chain than linear barcodes or human-readable text, making it easier for businesses to track products and help to protect consumers from the risk of foodborne illnesses—a key aim of FSMA 204. Furthermore, by including unique product data within a scannable 2D code, businesses can provide additional information to consumers, including automatic alerts when a code is scanned to advise of any potential food safety incidents or recalls which could make the food unsafe to eat. 

Considerations for Implementing Variable Data Printing 

To maximize the benefits of 2D codes and variable data printing, companies must ensure that the selected coding technology can match the speed and throughput of their production lines, with print quality that is high enough to produce scannable, industry-accepted 2D codes. Data accuracy is also crucial. 

Businesses should partner with industry-leading coding and marking providers to ensure that their coding solutions can satisfy this need and implement code inspection systems to ensure that all 2D codes are correct and scannable at the time of printing. 

A trusted variable data solutions provider should be capable of offering a complete, closed-loop code and check system and helping to make aligning FSMA 204 compliance with the global migration to 2D codes seamless.