Helpful Hint: GTINs and GLNs can be created using a GS1 Company Prefix. Learn More
How to Use GS1 Standards for FSMA Rule 204
- Product & Location Identification
- Label Creation
- Shipping Data
- Receiving Data
Assign GTINs and GLNs
Manufacturers and processors should categorize products based on the Food Traceability List (FTL) and can assign each identified product a Global Trade Item Number® (GTIN®). Best practice is for manufacturers to use the Global Data Synchronization Network™ (GDSN®) to flag these products with their trading partners. Farmers, manufacturers, processors, distributors, retailers, and restaurants can enumerate their physical location with Global Location Numbers (GLNs) for location description Key Data Elements (KDEs).
Create Labels for Cases and Pallets
Manufacturers and processors can create case labels using a GS1-128 barcode and include the product's Global Trade Item Number® (GTIN®), Batch/Lot, and Date Code. Pallets can also be labeled with a GS1-128 barcode encoded with a Serial Shipping Container Code (SSCC).
Sending Shipping Data
Manufacturers, processors, and distributors can utilize recommended GS1 Standards for shipping data, including Global Trade Item Numbers (GTINs), Global Location Numbers (GLNs), and Serial Shipping Container Codes (SSCCs). While not specifically called out in the U.S. Food and Drug Administration (U.S. FDA) Food Safety Modernization Act Rule 204 (FSMA Rule 204), the food industry is supporting the use of electronic data sharing methods, like the Electronic Product Code Information Services (EPCIS), to help facilitate recalls.
More on How to Implement
The U.S. Food and Drug Administration (U.S. FDA) recommends using data standards to meet Food Safety Modernization Act Traceability Rule (FSMA Rule 204) requirements. GS1 Standards are already widely used in the food supply chain and can be mapped to Key Data Elements (KDEs) and Critical Tracking Events (CTEs). The Electronic Product Code Information Services (EPCIS) or the Global Data Synchronization Network™ (GDSN®) can help share KDEs for CTEs with your trading partners for smoother recalls.
For additional details, our readiness checklist can help you identify who in your organization to involve, how to create a traceability assessment plan, and more.
The requirements of the Final Rule apply to all persons or companies who manufacture, process, pack, or hold foods on the Food Traceability List (FTL) (unless an exemption applies), regardless of whether the person/company is in the United States or a foreign country.
The U.S. Food and Drug Administration (U.S. FDA) outlines the requirements for recordkeeping as original paper records, electronic records, or true copies (such as photocopies, pictures, scanned copies, or other accurate reproductions of the original records). Electronic records may include valid, working electronic links to the information required to be maintained under this subpart. The required records must be made available to an authorized U.S. FDA representative upon request within 24 hours, along with any information needed to understand these records.
While the original deadline was January 20, 2026, the U.S. Food and Drug Administration (U.S. FDA) announced its intention to extend the deadline into 2028.
A Global Trade Item Number® (GTIN®) is a GS1 Identification Key used to identify a trade item, while the Global Location Number (GLN) is used to identify locations. The U.S. Food and Drug Administration (U.S. FDA) has defined a set of metrics, called Key Data Elements (KDEs), that correspond to different events in the supply chain, known as Critical Tracking Events (CTEs). A KDE, such as the GTIN, can be tied to a CTE or GLN.
You can keep your GLN information private or share only with specific trading partners and/or the U.S. FDA. By default, when you publish a GLN, it is shared with all GS1 US Data Hub Location View/Use subscribers - and with users globally and freely via the Verified by GS1 service. To change this default setting, click the Profile Icon, navigate to the Data Hub Settings, then the Default Share Settings link. Uncheck the box for Share Your Locations (GLNs). Then click the Save Settings button.
New to GS1 Standards?
The GS1 Standards for Food Traceability Online Certificate Course offers you the opportunity to learn the fundamentals of improving product visibility from source to consumption. In addition, you’ll learn how to enhance food safety by leveraging unique product identification for quick and precise recalls.