A Brief Guide to FSMA Rule 204

FSMA Rule 204? FTL? KDE? There's a lot of discussion going on in the food industry about the latest regulations from the US Food and Drug Administration (US FDA), and it can be difficult to understand. Considering your overall requirements, here are some tips:

  • The Food Safety Modernization Act (FSMA), signed into law in 2011, aims to strengthen food safety systems to protect public health.
  • Section 204(d), also known as FSMA Rule 204 or the FDA Food Traceability Final Rule, took effect in January 2023 and provides for end-to-end traceability across the food industry by requiring companies to maintain and provide certain information. Set up the framework. Also called information or records.
  • These rules describe specific key data elements (KDEs) that describe critical tracking events (CTEs), or supply chain steps, that should be recorded.
  • If you manufacture, process, package or store food that is on the Food Tracking List (FTL), you must keep and sometimes share these records.

Are you ready for the main course?

Fortunately, you may already have something in your kitchen that can help you meet your needs. The GS1 standard is already being used by many members of the food industry to improve food traceability. Global Trade Item Numbers (GTINs) are assigned to products throughout the food supply chain. Additionally, you can assign a Global Location Number (GLN) to your fields, packing houses, distribution centers, and other locations where you operate, giving you the same uniqueness in how you identify your location. This, along with other GS1 standards for identification, can help achieve the traceability required by FSMA Rule 204.

What is a GTIN?

International Trade Item Number® (GTIN®) is GS1® This is an identification key used to identify trade products. GTINs are used wherever products or services need to be identified along the supply chain. This includes modifications such as packaging, transportation, and transformation of the product.

The US FDA does not require product identification via GTIN. However, we note that companies that use GTINs for unique identification may already be linked to several required Key Data Elements (KDEs), such as product description elements. These KDEs can be linked to GTINs in the database and companies using this practice do not need to maintain this information separately.

What is GLN?

A Global Location Number (GLN) is a globally unique GS1 identification key used to identify parties and locations. Answer the “who” and “where” questions within your organization and across the entire global supply chain.

The U.S. FDA states that businesses that use location identifiers to distinguish locations (e.g., store numbers) between companies may choose to include that information as part of their location descriptions.

What is SSCC?

The Serial Shipping Container Code (SSCC) is a GS1 identification key used to identify a logistics unit. SSCC identifies a single logistics unit throughout the transport journey. Like a parcel tracking number, it serves as a single reference for your device during its journey from origin to destination. SSCC can be encoded as a barcode and placed directly on a product's logistics label to provide a physical representation of the item's identity.

Although SSCC is not required, the U.S. FDA recognizes that SSCC can be a useful tool to improve traceability.

provide success

The well-organized GS1 identification standards help you meet the requirements of FSMA Rule 204 by providing consistency and interoperability across a variety of environments and systems.

Leading manufacturers, suppliers, distributors, retailers and foodservice operators are already providing traceability within their supply chains to meet FSMA Rule 204 requirements. Find out how you can too.

About GS1 US:

GS1 USA® By strengthening their supply chains, companies can deliver safe, consistent, secure, and trustworthy experiences. Best known as the source for UPC barcodes, GS1 is a non-profit global data standards organization that creates a common language for companies to identify, capture and share trusted data that connects their physical and digital supply chains. Millions of businesses around the world are powering commerce with GS1 standards. Learn more at www.gs1us.org.