Prepare to Meet FSMA Rule 204 Labeling Requirements

Prepare to Meet FSMA Rule 204 Labeling Requirements

BY: ANTHONY BIENIEWSKI / DATE: 30/01/2025 / TOPICS: ALIMENTARE, LABEL DESIGN, LABEL TRACEABILITY, REGULATORY COMPLIANCE

Food-borne illnesses seem never-ending in the food industry, raising concerns for consumers. According to the Centers for Disease Control and Prevention (CDC), there are an estimated 48 million cases of food-borne illnesses in the US each year and 3,000 deaths. Recalls are happening more often due to an increase in the global sourcing of ingredients, which heightens the risk of contamination. This leads to the question—what is the Food and Drug Administration (FDA) doing about that?

The FDA is responsible for protecting the public’s health by defining labeling rules and enforcing recalls to ensure safety. Food producers and manufacturers must follow the rules put in place, such as the final rule for FSMA Section 204, set for full compliance by January 2026. Once finalized, there will be more prevention and faster identification, ultimately improving food safety for all consumers by enhancing traceability. 

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What is the difference between FSMA and FSMA Section 204?

FSMA

Food Safety Modernization Act (also known as FSMA) was signed into law in 2011 by President Barack Obama with the goal of easily addressing how to prevent foodborne illnesses and make the food system safer for consumers. FSMA is a major step in shifting focus from how food & beverage manufacturers, suppliers, and retailers respond to food contamination to how they prevent food contamination in the first place. So, how does FSMA help?

• Shifts more power over food safety controls from companies to the FDA because the FDA has mandatory recall authority and the ability to keep suspect food from being shipped, whereas food manufacturers don’t
• Requires food & beverage companies to establish or enhance operations, plans, and procedures for preventing food safety issues, including product recalls
• Requires food & beverage companies to rely more on emerging products and technologies that help keep food safe

At its core, FSMA serves as a prevention tool, aiming to address potential risks before problems arise, rather than reacting afterwards.

The FDA FSMA Final Rule for Preventive Controls for Human Food requires food & beverage companies to develop and implement a food safety system that includes hazard analysis and risk-based preventive controls. FSMA’s Preventive Controls Rule for Human Food requires firms to:

• Identify significant food safety risks
• Implement controls to mitigate the risks
• Monitor and verify the effectiveness of the processes
• Manage supply chain risks
• Document activities

FSMA Section 204

FSMA Section 204, the final rule, is a part of the original FSMA law but specifically focuses on food traceability. It requires additional recordkeeping, imposing a broad standard by identifying specific items in the Food Traceability List (FTL) that must be tracked and traced by all companies in the supply chain. This final rule enables a better and safer way to protect public health and food safety.

The rule was finalized in November 2022, but all persons subject to the recordkeeping requirements have until January 20, 2026, to comply. The FDA also highlighted the use of GS1 standards as part of the food safety plan, aiming to improve traceability and help meet FSMA requirements by the deadline.

FSMA 204 rules, regulations, and records

Now that we know the difference between FSMA and FSMA Section 204, you must understand which foods on the FTL need additional recordkeeping that meet the requirements.

FSMA Section 204 strictly speaks to the food & beverage industry and any companies that grow, ship, pack, process, manufacture or sell any of the foods on the FTL. All records kept by food manufacturers must have Critical Tracking Events (CTE) and Key Data Elements (KDE) which are FDA metrics that map to GS1 standards. CTEs are crucial events that require enhanced traceability recordkeeping throughout the supply chain and KDEs is the information that must be included in each record.

CTEs can be anything from harvesting to initial packing, to shipping, or receiving – any step in the supply chain. Some examples of KDEs are location name, date of events, unit of measurement, etc. These both tie in with a Global Trade Item Number (GTINs) and a GLN (Global Location Number).

Standards already exist to help farmers, growers, shipping/receiving, packers, manufacturers, processors, etc., achieve the degree of supply chain visibility required by FSMA Section 204. The Global Location Number (GLN) system established by GS1 US provides a unique 13-digit number for identifying all parties and locations in a supply chain.

A GS1 US-compliant barcode can identify everything from the specific farm, product type, and harvest date to ship date—information that becomes instantly available to every entity that handles the item along the supply chain.

Learn what key data elements you might be required to keep. Below is a list of the foods on the FTL.

• Leafy greens, melons, sprouts, cucumbers, tomatoes, peppers, fresh herbs, tropical tree fruits, vegetables other than leafy greens, and all fresh-cut items
• Soft ripened and semi-soft cheeses
• Shell eggs
• Nut butters
• Some categories of seafood (finfish, crustaceans, molluscan shellfish)
• Ready-to-eat deli salads

With FSMA Section 204 in place, responses to product recalls will be faster and more efficient due to the ability to pinpoint affected products, their locations, and a timeline of events, based on the records manufacturers will be required to maintain.

Acceptable records can be kept in their original paper format, or electronically, such as a spreadsheet. All records required for the final rule must be shared with the FDA within 24 hours of a request, then kept and stored for 24 months. Shipping events must also be shared with all supply chain partners.

The final rule will hold food manufacturers accountable and help reduce the number of product recalls or outbreaks and prevent illnesses to help protect consumers' health and safety.

How to prepare for FSMA Section 204 by January 2026 – full compliance

If you haven’t started to prepare for the final rule—you should start now. Taking the time to learn the new regulations and get an accurate labeling system in place is important to do ahead of time. Follow the steps below in order to meet full compliance by the January 2026 deadline.

• Conduct an internal audit and identify any ingredients that go into your products and are on the FTL
• Know the data you are required to track and store based on your role in the supply chain. Make sure everyone that works in labeling understands the FSMA rules.
• Leverage labels that align with PTI standards with human- and machine-readable GS1-128 barcodes
• For large retailers, processors, manufacturers, distributors, or foodservice operators—find traceability solutions to ensure compliance across your supplier network and standardize your labels across all suppliers with a unified supplier labeling system
• Find a labeling software that complies with industry regulations and supports food traceability and will continue to support it in the future

The connection between labeling software and traceability

Labels serve as the middleman when it comes to traceability. Compliant label design software like CODESOFT helps create labels that meet food industry regulations like FSMA Section 204. Some other labeling features you can benefit from in CODESOFT are:

• Helpful barcode and design wizards built within the software to make labeling easier, such as displaying batch/lot numbers, or pack/harvest dates
• Database connections that enable label templates to pull variable data for accuracy
• Data validation capabilities to prevent labeling errors
• On-demand RFID smart labels to help with traceability

Security and label traceability software like LABEL ARCHIVE integrates with CODESOFT label design software which can help increase labeling accuracy and:

• Create user rights and enable security controls
• Enforce a secure electronic label approval process to ensure only accurate labels enter production
• Gain security and version history control to ensure your labels and label printing process complies with the FDA and other industry standards
• Enable traceability and visibility in the supply chain by tracing recalled items back to the original source

CODESOFT paired with LABEL ARCHIVE helps food & beverage manufacturers reach full compliance and prevent product recalls.

TEKLYNX is here to help you remain compliant when new regulations arise

Remaining compliant with regulations such as FSMA 204 reduces liability in the case of recalls and increases consumer trust through transparency. Not only does this impact the consumer, but it creates a simpler and faster identification process, making the supply chain more efficient. Interested in CODESOFT? Download a free 30-day trial with full access to our customer support. Ready to buy? Buy now through our online storefront.

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Labeling accuracy is one of the food & beverage industry’s biggest allies in recall prevention. TEKLYNX provides food & beverage companies with barcode label software solutions that help increase labeling accuracy because the software significantly reduces the room for human error throughout the labeling process. Using a labeling provider that supports ever-changing regulations will set companies up for success in the future.