How Digital Traceability Is Reshaping Food Safety?

 Why Companies Must Adapt Now

The year is 2024, a multistate Listeria outbreak linked to Boar's Head deli meats has sickened 61 people across 19 states, hospitalised 60, and killed 10. The first patient was identified on May 29. The recall was not initiated until July 26, nearly two months later. In that interval, people continued consuming contaminated products, right up until the plant was closed in September. The same year, onions supplied to McDonald's Quarter Pounder hamburgers triggered an E. coli O157:H7 outbreak spanning 14 states, causing more than 100 illnesses, four cases of hemolytic uremic syndrome, and one death. According to data from the U.S. Public Interest Research Group, hospitalizations from foodborne illness in 2024 more than doubled compared to the previous year — from 230 to 487 — and deaths rose from 8 to 19 [1].

 

Neither of these outbreaks was, at its core, a mystery. What they were was slow, where slow to identify the contaminated lot and slow to trace it back through a supply chain that still relies, in significant parts, on paper-based records, incompatible software systems, and manual data entry. Slow to remove product from the market with the precision that modern technology should allow. The CDC's CORE Network data shows that, across 2020–2025, a food vehicle of illness was identified for only 56 percent of outbreak investigations, meaning 44 percent remained unsolved [2]. This is not a new statistic. It is a stubborn one. And it is precisely the number that the global push toward digital traceability is designed to change.

 

The transition is now happening at regulatory speed. The Institute of Food Technologists (IFT) has identified digital tools expanding food safety adoption as one of its top five trends shaping the global food system in 2026 [3]. The Food Marketing Institute (FMI), representing the retail food industry, has named traceability the number one food safety priority for 2026, placing it ahead of produce safety, chemical safety, and sanitation controls [4]. At the regulatory level, the U.S. FDA's Food Safety Modernization Act Rule 204, which was one of the most consequential pieces of food safety regulation in a generation, is rewriting the technical requirements for supply chain data across the entire food industry. Further beyond the United States, the European Union, China, and major trading blocs are simultaneously developing their own digital traceability frameworks, raising fundamental questions about interoperability, harmonization, and what it truly means to build a globally connected, digitally transparent food system.

 

The article examines what digital traceability is, why the industry is being compelled to adopt it now, what the regulatory landscape looks like globally, what technologies are enabling it, what barriers remain, and what food safety professionals and businesses must do in the near term to position themselves on the right side of a transition that is no longer optional.

 

What is Digital Traceability

Before examining the regulatory and technological landscape, it is worth being precise about the term itself, because "traceability" is used loosely in industry contexts in ways that can obscure meaningful distinctions.

 

Traceability, in its regulatory and scientific sense, is the ability to identify and follow the movement of a food product — or a substance intended to be incorporated into a food or feed — through all stages of production, processing, and distribution. The European Union's foundational General Food Law, EC Regulation 178/2002, established it as a legal requirement for all food and feed operators operating in the EU, using what it describes as a "one-step-back, one-step-forward" principle: each operator must be able to identify from whom they received a product and to whom they supplied it [5].

 

What makes digital traceability different from traditional traceability is the nature of the data and the speed at which it can be exchanged, queried, and acted upon. Traditional traceability systems relied on paper-based records, spreadsheets, and proprietary software that managed internal business processes without enabling real-time data exchange between supply chain actors. Digital traceability, by contrast, uses a combination of technologies — barcodes, RFID tags, QR codes, IoT sensors, electronic product code information services (EPCIS), blockchain, and cloud-based platforms — to create a continuous, machine-readable data trail that can be queried by any authorized party in real time [6].

 

The significance of the distinction becomes apparent the moment a recall is needed. A food business that can identify the contaminated lot within minutes and trace every downstream recipient within an hour is operating in a qualitatively different risk environment from one that requires days of manual record-searching. The FDA's vision, articulated in its New Era of Smarter Food Safety Blueprint, is explicit: the goal is faster and more targeted recalls, reduced scope of product removal, fewer illnesses, and ultimately lower costs for both industry and the public [7].

 

The Regulatory Architecture: What Is Being Required, and When

FSMA Rule 204: The United States

The FDA's Food Traceability Final Rule, commonly known as FSMA 204, was published in November 2022 and represents the most substantive expansion of federal traceability requirements since FSMA itself was enacted in 2011. At its core, the rule requires all persons who manufacture, process, pack, or hold foods included on the Food Traceability List (FTL) to maintain records containing Key Data Elements (KDEs) associated with Critical Tracking Events (CTEs), and to be able to provide those records to the FDA within 24 hours upon request [7].

 

The FTL covers a broad range of high-risk commodities: soft and semi-soft cheeses, shell eggs, nut butters, leafy greens, fresh herbs, cucumbers, peppers, tomatoes, sprouts, melons, tropical tree fruits, fresh-cut produce, certain finfish and molluscan shellfish, smoked finfish, crustaceans, and refrigerated ready-to-eat salads [7]. The scope is deliberately wide — these are the categories most frequently implicated in large, multi-state outbreaks, and they represent a substantial share of produce and protein consumption across the United States and for the global exporters who supply the U.S. market.

 

The rule's original compliance deadline of January 20, 2026, has been extended by 30 months to July 20, 2028, following an FDA announcement in March 2025 that acknowledged both the complexity of the rule and the significant technical preparation required across a diverse supply chain [8]. The 30-month extension was subsequently codified by Congress in the Continuing Appropriations Act of 2026. The FDA has been clear that this extension is a window for technical preparation, not a signal that the requirements are being relaxed. The agency hosted a major public stakeholder meeting on lot-level tracking as recently as June 15, 2026, and has actively solicited input on implementation flexibilities while holding firm on the fundamental requirement for digital, lot-level data capture and exchange [9].

 

One consequential development that underscores how the industry is not waiting for federal compliance dates: Walmart's supplier traceability requirements, mandating Advance Shipment Notices with KDE data, SSCC-18 pallet labels, and GS1-128 case labels, which took effect in August 2025, with chargebacks for non-compliant shipments already being assessed [8]. For the large proportion of food manufacturers serving mass retail, the federal compliance date is no longer the operational driver. Their largest customer's requirements already are.

 

The European Union Framework

The EU's approach to food traceability is embedded in a layered legislative architecture, where EC Regulation 178/2002 provides the foundational requirement for traceability across all food and feed operators [5]. On top of the given general framework sits sector-specific regulations for beef and beef labelling, fish and aquaculture products, genetically modified organisms, and organic produce. The EU Food Safety Authority (EFSA) and the German Federal Institute for Risk Assessment (BfR) have been actively developing a Universal Traceability data eXchange (UTX) format and an interoperable multi-actor tracing software ecosystem to support outbreak investigation and rapid alert systems [10].

The EU's Rapid Alert System for Food and Feed (RASFF) is one of the most mature food safety alert networks in the world, and the push toward digital traceability is in part designed to allow RASFF to function at the speed that modern supply chains demand. A 2024 editorial in the Journal of Consumer Protection and Food Safety makes the point directly: food safety authorities worldwide must intensify their efforts to collect and utilize digital traceability data, because as supply chains advance toward Industry 4.0, incorporating IoT sensors and digital twins, the volume of data will grow exponentially and authorities must keep pace [10].

 

The EU Deforestation Regulation (EUDR), which entered into force in 2023 and applies to a range of food commodities including soy, beef, palm oil, and cocoa, adds a further dimension to the EU's traceability requirements: companies must demonstrate that their products are free from deforestation, which in practice requires geolocation data and supply chain documentation down to the production plot level [11]. This represents a significant escalation in what traceability means in the EU context, which is not merely lot-level identification for recall purposes, but verifiable origin data at the level of individual farms and geographic coordinates.

 

China and the Broader Global Context

China has been actively developing national food traceability systems to address domestic food safety concerns and to support export competitiveness. The Chinese government has implemented a series of traceability platforms, including systems specific to pork, dairy, and infant formula, following high-profile food safety scandals that severely damaged consumer trust in domestic producers. A 2025 review in ScienceDirect notes that China's national food traceability architecture is evolving rapidly, though integration across regional systems and harmonization with international data standards remain works in progress [5].

 

The global picture, then, is one of multiple regulatory frameworks converging on a shared direction, “mandatory digital traceability”, while diverging in their specific technical requirements, covered commodities, and timelines. Thus, given divergence has significant practical implications for exporters operating across multiple regulatory environments. A company exporting leafy greens to the United States, fresh fish to the European Union, and dairy products to China must navigate three distinct traceability frameworks simultaneously, and the data formats, identification standards, and information disclosure requirements may differ materially between them.

 

The Technology Layer: What is Enabling Digital Traceability

The technologies underpinning digital traceability form an integrated ecosystem rather than a collection of isolated tools. Understanding how they work together is essential for food businesses making investment and implementation decisions.

 

GS1 Standards: The Universal Language

GS1 is the international, not-for-profit standards organization responsible for the global identification and communication standards that underpin product traceability. Its standards — particularly the Global Trade Item Number (GTIN) for product identification, the Global Location Number (GLN) for location identification, and the SSCC-18 for serialized shipping unit identification — are explicitly recognized by the FDA as a mechanism for meeting the KDE requirements of FSMA 204 [12]. The GS1-128 barcode encodes the GTIN, lot code, expiry date, and quantity on each case, and when combined with GS1's EPCIS (Electronic Product Code Information Services) standard for event data sharing, creates a foundation for interoperable, multi-actor traceability that does not require all parties in a supply chain to use the same software platform [12].

 

The practical significance of GS1 standards is that they represent the closest thing the industry currently has to a universal language for traceability data. A farm that captures harvest data using GS1-compliant identifiers, a processor that records transformation events using EPCIS, a distributor that generates GS1-128 case labels, and a retailer that scans those labels can all exchange traceability information without custom integrations — provided they are using standards-compliant systems. The "provided" clause is doing significant work in that sentence, because adoption of GS1 standards across the full supply chain is still uneven, particularly among smaller operators and producers in low- and middle-income countries [9].

 

Blockchain: Immutability and Multi-Party Trust

Blockchain technology in food traceability has attracted considerable attention since Walmart's landmark 2018 partnership with IBM Food Trust demonstrated that the time required to trace a food item from store to farm could be reduced from approximately seven days to 2.2 seconds using a blockchain-based system. By 2025, a systematic literature review in Business & Information Systems Engineering found that blockchain was the most frequently studied technology for food traceability, appearing in more than 40 percent of selected studies, typically deployed in combination with IoT sensors, RFID tags, or QR codes [13].

 

The fundamental contribution of blockchain to traceability is immutability — once data is entered into a distributed ledger, it cannot be altered retroactively without detection. Such property is valuable in the context of food fraud and in supply chains where multiple parties need to trust each other's records without placing complete confidence in any single actor's database. A 2024 research implementation reported in the blockchain literature showed fraud incident reductions of 80 percent and a rise in fraud detection rates from 70 to 95 percent, with consumer satisfaction index scores rising 12.5 percent [13].

 

However, blockchain's limitations are as important to understand as its benefits. The technology cannot protect against fraud that occurs before data is entered into the system, and the integrity of the physical-digital link depends entirely on the accuracy of the labelling and scanning processes at the point of data capture. As a Frontiers review noted, blockchain integration also requires the combination with IoT sensors and smart tags that automatically collect data, reducing the risk of human error or falsification; without this combination, the immutability of the ledger is only as strong as the honesty of the person entering the data [5]. Cost and scalability remain significant barriers, particularly for smaller operators.

 

IoT and Real-Time Monitoring

Internet of Things sensors: temperature loggers, GPS trackers, RFID readers, and humidity monitors, provide the data capture layer that converts physical events in the supply chain into machine-readable records. Under FSMA 204, the FDA's concept of Critical Tracking Events includes not just growing, receiving, transforming, and shipping, but the conditions under which food is held and transported. IoT sensors can automatically log these conditions in real time, generating continuous data streams that can populate KDE records without manual data entry and trigger alerts when conditions deviate from safe parameters.

 

The FDA's own Low/No-Cost Traceability Challenge, a program designed to identify accessible traceability solutions for smaller operators, recognized both blockchain and IoT as breakthrough solutions precisely because of such automation potential [12]. The cost of IoT sensor hardware has fallen significantly over the past decade, and cloud-based data platforms that aggregate sensor data from multiple supply chain actors are increasingly accessible. For cold chain management specifically, a critical dimension of traceability for fresh produce, seafood, and dairy, where IoT monitoring is rapidly transitioning from a value-added feature to a baseline expectation among major retailers and regulatory bodies.

 

Rapid and Digital Testing Integration

A dimension of digital traceability that is sometimes overlooked is its integration with rapid testing at production and processing points. Next-generation sequencing, rapid immunoassay platforms, and digital PCR systems are generating pathogen detection data in hours rather than days, and the ability to link that testing data directly to lot-level traceability records creates a closed loop between quality control and supply chain documentation. Whole genome sequencing (WGS), already used by FDA and CDC in outbreak investigations to match environmental strains to clinical isolates, is being positioned as the epidemiological backbone of the next generation of foodborne illness surveillance, but its value is amplified when the supply chain records it needs to cross-reference are digital, lot-level, and rapidly accessible [2].

 

The Interoperability Problem: Why Standards Alone Are Not Enough

The single most consequential structural challenge facing digital traceability implementation is interoperability, the ability of different software systems used by different actors in the supply chain to exchange and analyze data accurately and efficiently. The point at which good intentions most frequently collide with operational reality.

 

A 2024 editorial in the Journal of Consumer Protection and Food Safety, authored by Marion Gottschald of the German Federal Institute for Risk Assessment, made this structural problem explicit: while the food industry uses numerous tracing software systems, they are mostly focused on managing internal business processes rather than facilitating data exchange between actors [10]. Food safety authorities have access to some inter-agency tools, including RASFF and FoodChain-Lab, but the widespread adoption of genuinely interoperable software is limited by the lack of available digital traceability data and the limited standardization of tracing data formats across the industry.

 

A 2025 Frontiers systematic review of digitalization in European agri-food supply chains echoed that finding: most studies in the peer-reviewed literature describe conceptual frameworks or pilot implementations rather than fully realized systems, and real-world deployment is hampered by interoperability challenges, scalability issues, regulatory uncertainties, and high costs [14]. The review found that to ensure interoperability across processing and retail stages, harmonized standards, shared APIs, and common data taxonomies are needed, which is a recommendation that has been made many times and implemented unevenly.

 

The practical implication for a food business today is that investing in a traceability system that works internally but cannot communicate with the systems used by suppliers and customers upstream and downstream does not fully deliver on the promise of digital traceability. The value of traceability data is a network effect, which increases with the number of actors who can access, contribute to, and act on it. A manufacturer who has invested in GS1-compliant systems and EPCIS event sharing but whose primary fresh produce supplier is still using paper manifests is operating with a significant gap in their data chain.

 

The FDA stakeholder meeting of June 2026 on lot-level tracking heard exactly the concern from food industry representatives: traceability data today comes in many formats (paper, spreadsheets, and incompatible software systems), which creates both inefficiencies and compliance risks. Participants broadly identified GS1 standards as the most practical common language for global supply chains, while acknowledging that adoption is uneven and that the costs and technical barriers for smaller and less capitalized operators are real [9].

 

TO BE CONTINUED

 

References

[1] U.S. Public Interest Research Group (PIRG) Education Fund. (February 2025). Food for Thought 2025: How safe is our food?. https://pirg.org/edfund/resources/food-for-thought-2025/

[2] Prabhukhot, G. (2026). Regulatory responses to foodborne illness outbreaks in the United States and their implications for food safety. Frontiers in Nutrition, 12, 1717980. https://doi.org/10.3389/fnut.2025.1717980

[3] Niemira, B. (December 2025). What's on the Menu for 2026? IFT's Top Five Food Trends. Institute of Food Technologists. https://www.ift.org/news-and-publications/blog/2025/whats-on-the-menu-for-2026

[4] Eisenbeiser, A. (February 9, 2026). Building the Safest Food System Together: FMI's 2026 Food Safety Priorities. FMI – The Food Industry Association. https://www.fmi.org/blog/view/fmi-blog/2026/02/09/building-the-safest-food-system-together--fmi-s-2026-food-safety-priorities

[5] Reitano, A., et al. (2025). Agri-food traceability today: Advancing innovation towards efficiency, sustainability, ethical sourcing, and safety in food supply chains. Trends in Food Science & Technology. https://www.sciencedirect.com/science/article/pii/S0924224425002900

[6] Frontiers in Sustainable Food Systems. (April 2026). Food safety and its digital traceability strategies: a supplier-processor profit distribution perspective. https://www.frontiersin.org/journals/sustainable-food-systems/articles/10.3389/fsufs.2025.1707114/full

[7] U.S. Food and Drug Administration. FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule). https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods

[8] INECTA. (2026). FSMA 204 Compliance Guide: KDEs, CTEs & July 2028 Deadline. https://www.inecta.com/blog/fsma-204-compliance-guide

[9] OFW Law. (June 23, 2026). FDA's Next Steps on Traceability: Challenges and Solutions in Lot-Level Food Traceability. https://ofwlaw.com/fdas-next-steps-on-traceability-challenges-and-solutions-in-lot-level-food-traceability

[10] Gottschald, M. (2024). Advancing food safety through digital traceability, interoperability, harmonized data and collaborative partnerships. Journal of Consumer Protection and Food Safety, 19, 257–258. https://doi.org/10.1007/s00003-024-01522-8

[11] Natural Trace. (2024). Recent Regulations Driving Traceability in Food and Agriculture Sectors. https://natural-trace.com/recent-regulations-driving-traceability-in-food-and-agriculture-sectors/

[12] GS1 US. Food Safety Modernization Act (FSMA 204): How GS1 Standards Can Help. https://www.supplychain.gs1us.org/standards-and-regulations/food-safety-modernization-act

[13] Vasileiou, K., et al. (2025). Digital Transformation of Food Supply Chain Management Using Blockchain: A Systematic Literature Review Towards Food Safety and Traceability. Business & Information Systems Engineering. https://doi.org/10.1007/s12599-025-00948-0

[14] Frontiers in Blockchain. (October 2025). Digitalization in the European agri-food supply chain: a scoping review of traceability, transparency, and sustainability. https://www.frontiersin.org/journals/blockchain/articles/10.3389/fbloc.2025.1701872/full