Editor's note: The FDA announced on March 20 that it intends to push back the compliance deadline 30 months from the original date of Jan. 20, 2026.

The FDA final rule on Requirements for Additional Traceability Records for Certain Foods establishes traceability recordkeeping requirements, beyond those in existing regulations, for persons who manufacture, process, pack or hold foods included on the Food Traceability List (FTL). The final rule is a key component of FDA’s New Era of Smarter Food Safety Blueprint and implements Section 204(d) of the FDA Food Safety Modernization Act (FSMA). The new requirements identified in the final rule will allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.

At the core of this rule is a requirement that persons subject to the rule who manufacture, process, pack or hold foods on the FTL, maintain records containing Key Data Elements (KDEs) associated with specific Critical Tracking Events (CTEs); and provide information to the FDA within 24 hours or within some reasonable time to which the FDA has agreed.

“Additionally, there is a need for accountable record maintenance for up to two years,” says Jim Bresler, Plex Systems director of product management, food & beverage. “Companies that have invested in digital lot traceability systems will be best prepared for compliance on Jan. 20, 2026.”

The Food Traceability List and Tracking

The Food Traceability List includes products that have often been the subject of food safety recalls. Examples include soft cheeses, shell eggs, nut butters, fresh cucumbers, fresh and fresh-cut leafy greens, fresh melons, peppers, sprouts, tomatoes, tropical tree fruits, fresh-cut vegetables, fresh and smoked finfish (e.g., tuna, swordfish and mahi mahi), crustaceans, mollusks and RTE salads.

According to FDA, those who manufacture, process, pack or hold foods on the FTL must maintain and provide to their supply chain partners specific information KDEs for certain CTEs in the food’s supply chain. This framework forms the foundation for effective and efficient tracing and clearly communicates the information that FDA needs to perform such tracing.

The information that firms must keep and send forward under the rule varies depending on the type of supply chain activities they perform with respect to an FTL food, from harvesting or production of the food through processing, distribution and receipt at retail or other point of service. Central to the proposed requirements is the assignment, recording and sharing of traceability lot codes (TLCs) for FTL foods, as well as linking these lot codes to other information identifying the foods as they move through the supply chain.

Are Processors Prepared for FSMA 204?

It depends. For a few retail outlets, processors and their supply chains are already on board, otherwise, not so much, says Randy Fields, ReposiTrak CEO. “The industry is not prepared for FSMA 204 food traceability, but food and beverage processors are moving rapidly toward compliance due to pressures beyond the regulatory need to comply.”

“Major retailers, including Kroger, Target, Albertsons’ and Walmart now require traceability for all foods or entire categories of food, not just what’s included in the FDA’s Food Traceability List (FTL),” Fields adds. “That means in order to maintain the relationships that suppliers have built with these companies they’re going to have to figure out how to do traceability — fast. In other words, the food and beverage processors who can do traceability will have the competitive advantage over processors who can’t.”

“We see many North American food and beverage processors ‘actively preparing’ for FSMA 204 compliance, but readiness varies across the supply chain,” says Maggie Slowik, global industry director, manufacturing at IFS.

“It comes down to the data management piece,” Slowik adds. “Larger organizations with established traceability systems are generally more knowledgeable and better prepared while smaller processors and upstream suppliers, such as growers, may still be catching up.”

The challenge lies in ensuring seamless data compatibility from farm to fork, Slowik says. “Retailers and larger processors tend to be ahead of the game due to existing digital traceability initiatives, while smaller producers and some distributors may need further support in integrating standardized lot codes and data-sharing practices.”

Parts of the supply chain are well on the way to complying with the FSMA 204 rule, says Heath England, president of Trace Register. “Seafood farmers, vessels and production companies have less to manage as they often assign the lot code and do not have to make huge adjustments to previous processes. The downstream supply chain has the bigger lift. They must have a way to receive, maintain and transmit information they may not be doing today. The parties that seem to be struggling the most have never had to deal with this type of information, i.e., warehouses, retailers at the store level and restaurants.”

“There is no uniform answer to this question due to the high degree of variability in the food industry — between establishments of different sizes and maturities, between different industry verticals and across various steps in the supply chain,” says Steven Burton, founder & CEO of Icicle Technologies Inc. “We routinely encounter establishments at every stage of the journey to FSMA 204 compliance, ranging from fully GFSI-certified operations to those with absolutely no food safety or traceability program in place.”

Generally, small, young companies are far less prepared, Burton adds. “Many may not even understand basic food safety hazards, such as biological, chemical, physical or radiological risks — let alone their obligations under FSMA 204.”

Jim Toman, engineer – smart MES at Grantek, a Control System Integrators Association (CSIA) certified member, sums up the challenges processors are facing:

• Understanding the requirements of FSMA 204 and how they apply to operations, facilities and enterprise
• Ensuring that all employees are trained on the new requirements and understand their role in compliance
• Understanding the financial challenges in implementing the necessary changes to comply with FSMA 204.

“The food & beverage manufacturers we work with are typically busy keeping their plants running and dealing with issues associated with supply chain disruptions, workforce shortages, unplanned downtime and more — so most are likely familiar with the FSMA 204 ruling, but have not taken much action yet,” says Richard Phillips, PE, PMP, director of smart manufacturing at Polytron, Inc., a CSIA certified member. “Manufacturers will be more equipped with meeting the requirements as compared to growers/producers and end users such as restaurants and grocery stores, since manufacturers already have much of the infrastructure required for traceability and are in the middle of the supply chain. Therefore, manufacturers will need to take the lead in this initiative across their supply chain.”

The Traceability Lot Code and GS1-128

The new ruling requires a traceability lot code (TLC), which is assigned when the food is initially packed or received from a fishing vessel (if seafood) or transformed in some way. The FDA shows five examples of traceability lot codes, one of which includes a GS1-128 example.

The question is: Would it be easier for food producers/processors/shippers who already use GS1 codes simply to use the GS1-128 code, rather than cook up a unique company-created code since GS1-128 accommodates unique company-created data?

This question drew surprisingly mixed responses — from using the code to a mix of using it along with private coding to not using it. “We typically recommend that our customers follow industry established guidelines for several reasons,” says Polytron’s Phillips. Standardization across the industry gives suppliers, manufacturers and end users a framework to work with. There is usually a lot of thought and review put into these standards.

“Although the GS1-128 code may seem like a simpler solution for food and beverage manufacturers looking to ensure compliance with FSMA 204, it is important for food producers, processors and shippers to carefully consider their specific operations before making this decision,” says Grantek’s Toman. While the GS1-128 code provides standardized information and can be easily read by scanners, it may not capture all the necessary data required by FSMA 204.

“Using a unique company-created code allows for more detailed and specific information, including all KDEs to be included in the product label or packaging, which can be crucial for traceability across all CTEs in the event of a food safety issue,” Toman adds. “It also allows food and beverage manufacturers to have more control over their data and ensures they are meeting all applicable requirements.”

From a systems standpoint, GS1 identifiers make everything easier, says Trace Register’s England. “Our platform is built on GS1 standards and identifiers. However, there are some cases where it becomes challenging to manage raw materials using a GS1-128 due to the unique nature of seafood. Once packaged, there is no doubt that a GS1-128 is the best practice for all involved.”

“For many companies, the cost required to adopt the GS1-128 code is too much to bear,” says ReposiTrak’s Fields. “What we find is that only about 5% of the companies in the ecosystem out of the 30,000 suppliers that we have visibility to are GS1 compliant and it’s going to be a long difficult slog to get the rest of the suppliers there.”

The GS1-128 standard allows for unique, company-specific data to be inserted into the barcode in a standardized format that can be easily understood by others, says Icicle’s Burton. Thus, it is almost always better to use the supplier’s GS1-128 code for traceability purposes, although internal codes may also be assigned if required.

Burton suggests three reasons for using the supplier’s GS1-128 code:

1. Sustainability: If an item is received with a GS1-128 barcode already attached, it may be unnecessary to print new labels, reducing waste and promoting sustainability.
2. Interoperability: The GS1 standard is global, so a GS1-128 barcode can be read by virtually anyone with a barcode scanner, ensuring compatibility across different systems.
3. Standardization: The components of a GS1-128 barcode, known as Application Identifiers (AIs), are fixed and described in the GS1 standard. This makes it easy to parse the human-readable portion of the barcode and identify individual components, such as the lot code, weight, etc. Standardization avoids issues like date format and unit confusion. It also simplifies training for new workers, as handling a large variety of different code types can quickly become overwhelming.

Finally, according to Plex’s Bresler, the GS1-128 standard consists of a set of application identifiers that allow encoding of various “segments” of information into a single barcode that can include GTIN (company-specific item identifier that is assigned by the GS1 organization), lot number, expiration date, facility number, weight, etc., constructing a string that can be printed using the UCC 128 format, and which can be scanned and parsed to extract the information in the barcode. It is still necessary to assign unique lot codes for traceability purposes to build the GS1-128 string. GS1-128 labels are a convenient way for customers to receive product and electronically ingest lot and other information from the barcode.

However, the lot number has to change every time product is repacked or transformed downstream.

Determining a Lot Size and Lot Code

Since FDA’s Food Traceability Rule doesn’t prescribe a specific way producers must define a traceability lot, determining lot size is up to the manufacturer, says Grantek’s Toman. He notes some considerations.

First, it is important for the food and beverage manufacturer to consider the potential risks associated with each product or ingredient. High-risk products or ingredients may require smaller lot sizes to accurately trace and contain any issues that may arise. Smaller lot sizes may also allow narrower targeted recalls in the event of a food safety incident.

In addition, the complexity of the supply chain should also be considered. If a product goes through multiple stages of processing and distribution before reaching consumers, a smaller lot size may be necessary to ensure accurate traceability at each stage.

Smaller lot sizes may also generate more tracking data, and may require more material handling, than larger lot sizes. This increased complexity may be less appropriate for higher-volume, low-variability and lower-risk products, Toman says.

Fundamentally there needs to be a risk-based assessment of the probability of an actual contamination that would result in a recall versus the extra effort to track lots at a highly granular level, says Plex’s Bresler. The greater the risk level, the smaller the produced lots should typically be. It can make sense to shift to a new production lot when:

1. There is a change in lot number of a key ingredient (one that adds recall risk – so a new lot of milk as a source item might drive a new lot number assignment for output, but a new lot of salt might not)
2. When a new production batch is started
3. Every X hours
4. At shift change, etc.

The FDA defines a TLC as a descriptor, often alphanumeric, used to uniquely identify a traceability lot (production batch/lot), says Lucy Angarita, director, supply chain visibility, GS1 US. “Examples given by the FDA do not require a specific format for a TLC as long as companies can identify their production batch/lot. The GS1-128 is a data carrier or barcode that has been used in food for years (the produce industry has used it since 2010, as well as seafood and dairy). Within this barcode, our industry members have agreed that encoding a GTIN + batch/lot is the best way to communicate the TLC. Industry has also agreed that including a date (such as expiration or pack date) in the barcode is best practice to help in inventory management and other supply chain processes. This has been endorsed by several industry associations, operators and retailers in their guidelines and letters.”

A frequent mistake is deviating from the GS1 standard by using non-alphanumeric characters (e.g., periods, dashes) in lot codes, says Icicle’s Burton. Adding such characters increases the density of the GS1-128 barcode, which can diminish its readability by scanning engines. To ensure optimal readability, it’s important to adhere to GS1 standards and avoid unnecessary complexity in lot code formatting.

Track & Trace Software Support for GS1-128: To What Extent?

ERP systems may support GS1-128 differently. For instance, according to Plex’s Bresler, not all ERP systems natively support GS1-128 barcode printing and barcode scanning/parsing, but there are additional software tools that can be employed to add those capabilities.

“Most software that I am aware of supports GS1-128,” says Trace Register’s England. “Our platform supports all GS1 identifiers for product, location and trading partner.”

However, some software systems are more rigid than others and do not provide the flexibility required to deal with different codes used throughout the supply chain, says Polytron’s Phillips. “We use a platform that provides the needed flexibility to accommodate a client’s specific requirements, while still fitting within the traceability functionality.”

Another way of looking at it is that every company except the retailer has an input and an output problem and what that means is the suppliers may not use GS1-128 but they have to accept the information anyway so we do that for them, says ReposiTrak’s Fields. “And when they send information to their customers, there’s another problem because many of their customers can’t accept GS1. Our role in the traceability ecosystem is to be agnostic, sort of a ‘universal translator’ that converts GS1-128 or any other codes used into data that can be read by any traceability system.”

To provide support to all, GS1 US has developed actionable guidance and tools with our food industry members that represent all voices in the supply chain. For example, the organization has developed a FSMA 204 Implementation Toolkit, which is a one-stop shop for all GS1 US FSMA 204 resources, but also contains links to GS1 US foundational information, says GS1’s Angarita.

Resources

“FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods,” FDA, accessed 1-31-2025

“Track and Trace Gets a Boost from GS1 12 and 128 Barcodes,” FE, March 11, 2024

GS1 US Website: https://www.gs1us.org/; global: https://www.gs1.org/