Why GS1 Standards Are a Smart Choice for FSMA 204 Compliance
FSMA 204 is reshaping food traceability by requiring fast, accurate tracking of certain high-risk foods across the supply chain. Although the FDA does not mandate the use of GS1 standards, many companies are adopting them as the foundation for compliance due to their global recognition and structured approach. GS1 standards—such as GTINs for products, GLNs for locations, and EPCIS for event data—help businesses capture and share traceability information in a consistent, interoperable format. The result: streamlined compliance, improved accuracy, and faster response during food safety events.
GTINs: Supporting Accurate Product Identification Under FSMA 204
A Global Trade Item Number (GTIN) is a globally recognized, unique identifier used to distinguish products at every level of packaging—from a single consumer unit to a master case or pallet. GTINs are part of the GS1 system of standards and serve as the backbone for identifying and tracking products throughout the supply chain.
GTINs can be 8, 12, 13, or 14 digits long, depending on the type of product and how it’s being packaged or sold. In the U.S., the 12-digit version is commonly known as a UPC (Universal Product Code), which is what you typically see scanned at retail checkouts. The 14-digit GTIN is often used to identify cases or pallets in B2B environments.
Each GTIN is tied to a specific product and version—meaning even a slight change in size, flavor, or packaging would require a new GTIN. This level of precision is what makes GTINs so valuable for traceability under FSMA 20
Benefits of Using GTINs
- Consistent product identification across the supply chain
- Faster tracebacks during food safety investigations
- Reduced errors caused by ambiguous product names
- Clear communication between trading partners
- Alignment with FDA expectations for structured, interoperable data
Managing GTINs with GS1 US Data Hub®
GS1 US Data Hub | Product makes it easy for companies to:
- Assign and manage GTINs
- View packaging hierarchies (item, case, pallet)
- Link GTINs to product attributes like brand and classification codes
- Share GTIN data with supply chain partners
- Align product records with FSMA 204 recordkeeping requirements
Combined with standards like EPCIS and CBV, GTINs allow businesses to document the what, when, where, and why of each product’s journey in a consistent format.
GLNs: Standardizing Location Data for Traceability
A Global Location Number (GLN) is a 13-digit identifier that pinpoints physical locations—farms, packing facilities, warehouses, and more. FSMA 204 recommends GLNs to support the “Location Description” KDE required at key supply chain events such as harvesting, receiving, and shipping.
Why Use GLNs?
- Standardized location data across the supply chain
- Faster, more accurate FDA reporting within 24 hours
- Reduced manual entry errors
- Clear traceability links between products and facilities
- Improved integration with trading partners and systems
GS1 US Data Hub | Location
With GS1 US Data Hub | Location, businesses can:
- Create and manage GLNs for all operational sites
- Map internal location codes to GS1-recognized identifiers
- Add metadata like GPS coordinates and business functions
- Control what data is shared with partners and regulators
- Validate location data and reduce onboarding time
SSCCs: Tracking Shipments with Precision
The Serial Shipping Container Code (SSCC) is an 18-digit identifier used to track individual logistics units like pallets and crates. It’s essential for tying physical products to digital records, especially in FSMA 204 scenarios where shipment-level traceability is required.
Key Advantages of SSCCs
- Unit-level traceability
- Automated links to GTINs, lot numbers, and expiration dates
- Fast, accurate shipping and receiving processes
- Seamless integration with the ASN (Advance Ship Notice)
Used on logistics labels and scanned at each point, SSCCs keep your digital and physical supply chains connected.
EPCIS & CBV: Structuring Supply Chain Events
EPCIS (Electronic Product Code Information Services) and CBV (Core Business Vocabulary) are GS1 standards designed for real-time, structured traceability. Together, they enable companies to capture and share event-based data—answering the what, when, where, why, and how of a product’s lifecycle.
What’s New in EPCIS 2.0?
- Sensor Data Integration for monitoring conditions like temperature
- Certification Tracking for sustainability and food safety claims
- JSON/JSON-LD Syntax for modern application compatibility
- REST APIs for faster data exchange
- GS1 Digital Link Integration to embed identifiers in web-connected formats
By implementing EPCIS and CBV, companies can trace items with precision, link production events to certifications, and stay ahead of compliance requirements.
EDI & ASN: Automating Data Exchange
The EDI 856 Advance Ship Notice (ASN) is a critical tool for automating the capture and sharing of KDEs at shipment level. GS1 standards like GTINs and GLNs are embedded directly into the EDI transaction—enabling consistent, accurate reporting.
What the ASN Captures
- Header Level: Shipment ID, timestamp
- Shipment Level: Ship-from/ship-to GLNs, shipment date
- Pack Level: GTINs, batch/lot numbers, quantities, and traceability lot codes
GS1 US provides implementation support across multiple EDI versions, ensuring smooth integration with legacy and modern systems.
GS1 Data Carriers: Enabling Automatic Data Capture
To support FSMA 204, companies need efficient ways to encode and read product data. GS1-approved data carriers make that possible, ensuring accurate data capture across every point in the supply chain.
Common GS1 Data Carriers
- Linear Barcodes (GS1-128) – Ideal for pallets and cases
- 2D Barcodes (DataMatrix, QR with Digital Link) – Compact, high data capacity
- RFID – Enables bulk scanning without line-of-sight
- GS1 Digital Link – Connects physical products to online records
Each carrier uses Application Identifiers (AIs) to specify data types, such as (01) for GTIN or (17) for expiration date. Choosing the right carrier depends on your operational needs, but all help improve automation and traceability under FSMA 204.
Final Thoughts
While FSMA 204 doesn’t require the use of GS1 standards, leveraging them offers a clear path to compliance. From identifying products with GTINs to tracking shipments with SSCCs and structuring data through EPCIS, GS1 standards help businesses meet FDA expectations with confidence. By adopting these tools, companies not only streamline their compliance efforts—they also build smarter, more resilient supply chains ready for the future.
Additional Resources
Access helpful documents, tools, and guidance here.
Supplier Onboarding & FSMA 204 Compliance
Find specific support for onboarding suppliers and meeting FSMA 204 requirements here.