In the United States, approximately 48 million people are affected by foodborne illnesses each year, leading to 128,000 hospitalizations and 3,000 deaths[i]. These numbers represent a significant public health challenge that can be largely prevented with effective traceability measures.
The Food Safety Modernization Act (FSMA) 204, with its recent updates, aims to enhance food safety in the US by focusing on preventing foodborne illnesses through improved data-driven transparency and accountability within the food system.
By the final implementation deadline of January 20, 2026, organizations have a valuable opportunity to align FSMA 204 compliance with the global industry trend towards 2D barcodes at the point of sale. This integration not only streamlines changes and minimizes disruptions but also extends the benefits of traceability beyond mere compliance, as highlighted by Adem Kulauzovic, Director of Automation at Domino Printing Sciences.
FDA Traceability Rule FSMA 204
Section 204 of the FDA Food Safety Modernization Act introduces traceability record-keeping requirements for businesses involved in the manufacturing, processing, packaging, or holding of certain high-risk food products.
FSMA 204 impacts businesses handling food items listed on the Food Traceability List, which includes cheeses, fresh eggs, nut butters, fresh fruits and vegetables, fish, shellfish, and ready-to-eat deli salads.
Foreign companies handling products for consumption in the US must also adhere to the same traceability requirements as US-based companies. Given that the US imports a significant portion of its food supply, including fresh vegetables, fruit, and seafood, compliance with these regulations is crucial[ii].
What does FSMA 204 stipulate?
FSMA 204 requires businesses to maintain and process data on Critical Tracking Events (CTEs) that represent stages within the supply chain at higher risk of food safety incidents. Tracking CTEs allows businesses to identify contamination sources quickly and respond effectively.
Businesses must keep records containing Key Data Elements (KDEs) to track CTEs efficiently. These records, based on traceability lot codes, help identify foods throughout the supply chain.
Implementing FSMA 204 involves collecting and sharing data at key supply chain points, retaining records for two years post-sale or distribution, and making traceability information accessible to the FDA in electronic format within 24 hours when requested.
Compliance is vital, as non-compliance can lead to civil or criminal repercussions. FSMA 204 was enforced in January 2023, with affected organizations given until January 20, 2026, to meet the requirements, ensuring thorough preparation and implementation.
Preparing for compliance with FSMA 204
Companies seeking compliance with FSMA 204 can align their traceability record-keeping with guidelines by capturing necessary KDEs as part of their coding and marking efforts.
Identifying data capture gaps in the supply chain and collaborating with partners to record essential data is the first step. Implementing coding and marking systems that allow for seamless data tracking across the supply chain is essential.
Companies can incorporate batch and lot information into product codes through variable data printing, allowing for alignment with FSMA requirements using scannable 2D codes, such as QR codes powered by GS1.
Aligning FSMA 204 with move to 2D barcodes at the point-of-sale
Incorporating 2D codes into products, alongside variable data printing, offers additional benefits beyond FSMA compliance by enhancing traceability and product protection throughout the supply chain.
Integrating FSMA traceability data into QR codes powered by GS1 at retail points of sale ensures alignment with industry trends towards 2D barcodes. This alignment minimizes the need for future technology adjustments and offers enhanced traceability benefits.
Considerations for implementing variable data printing
To maximize the benefits of 2D codes and variable data printing, businesses must ensure that their coding technology matches production line speed and throughput, maintains high print quality for scannable codes, and prioritizes data accuracy.
Partnering with leading coding and marking providers to implement code inspection systems can ensure all 2D codes are correct and scannable during printing, thus facilitating seamless compliance with FSMA 204 and the adoption of 2D barcodes.
For more information on Domino, visit www.domino-printing.com
