Warehousing and Compliance - Navigating Regulatory Changes

Author: Scotty Lee, Partner Strategy Manager, Seagull Scientific

Quick Overview:

  • Warehousing operators must comply with legislative standards for traceability throughout the supply chain and for worker health and safety.
  • Many warehousing operators seek certification for international standards for safety and quality to give them a competitive edge. 
  • We identify the seven must-have features in a labeling system if it is to help manage compliance and worker safety.

 

Legal compliance in the warehousing sector
Within the warehousing sector, compliance with industry legislation is a high priority. Many of the products that pass through a warehouse are subject to strict legal requirements, particularly food and medicinal items. There is stringent legislation to keep these goods secure, ensure they are safe, and to protect consumers from counterfeit goods. Products must be traceable at all stages throughout the entire supply chain, so warehouses have the same level of obligation as manufacturers and retailers when it comes to track and trace compliance in having goods properly labeled. 


Warehouses also have a legal obligation to keep their workers safe by providing a workplace and processes that are appropriately set up, equipped, and managed.
Non-compliance carries a high price, not only financial, but reputational too. Consequences for those who don’t meet the compliance laws range from fines to complete shutdown of operations. 


While regulations vary by jurisdiction, the primary ones in the US and Europe are:

  • FSMA 204 – from January 2026, the Food Safety Modernization Act tracks foods on a designated Food Traceability List (FTL). Manufacturers of these foods must maintain records and share information with other entities in the supply chain, including warehouses.
  • DSCSA - the Drug Supply Chain Security Act (DSCSA) applies to prescription drugs and enforces interoperable, electronic tracing of products. That means that products can be traced all the way through the supply chain, with the aim of eliminating the entry into the market of counterfeit, stolen or contaminated products. The legislation requires labeling in human readable and machine readable (barcode) formats, using industry-wide standards.
  • UDI – Unique Device Identifier regulations apply to the medical device sector. The UDI must be clearly shown on the device, its packaging and labels. There is a mandated format for the barcode, and information about the product must also be recorded in Global Unique Device Identifier Database (GUDID) in the US, or the EUDAMED database (in Europe, from April 2026).
  • Occupational health and safety – the rules to keep workers safe vary by country and by regulating body. In the US, the governing body is the Occupational Safety and Health Administration (OSHA), in Europe the equivalent is the EU-OSHA, while in the UK, it’s the Health and Safety executive, and in Australia it is Safe Work Australia. Whichever the country and governing body, there are strict regulations about working conditions, designed to keep workers safe and free from harm.

ISO Certifications
Many warehouse operators go further than the mandatory requirements, seeking certification by the International Standards Organisation (ISO), particularly for quality (ISO 9001) and safety (ISO 45001). For larger warehousing organizations, winning and retaining major clients would not be feasible without ISO recognition which is granted after rigorous examination and audit of their processes and facilities. For example, for ISO 45001, a warehouse will have to be able to show how it identifies hazards and minimizes risk. For ISO 9001, there are two primary measures of the quality of fulfilment – error rates and shipping times, and warehouses must be able to show that they have standardized processes with efficient and scalable systems. 

The role of labeling  
Labeling plays a significant role in meeting the demands of regulations and certifications. For example:

  • The labels on hazardous materials not only identify them as such, but also provide essential safety information in the case of an incident.
  • Labeling shows where items should be stored, helping to implement safety policies, such as having heavier items on low shelves.
  • Labeling with standardized barcodes is the key to the interoperability and traceability required for food, drug, and medical equipment legislation.
  • Labeling enables process automation, standardization, and scalability.
  • Clear labeling ensures that goods shipped from warehouses reach the correct destination and can be tracked through the downstream parts of the supply chain. 

What should warehouses look for in a labeling solution for compliance? 

  1. Label design – labels must provide essential information in both machine-readable and human formats. Label design, including the use of icons, images, and color, as well as barcodes, ensures rapid access to the information.
  2. Automation of label production process – leveraging Enterprise Resource Planning (ERP) systems with other systems allows for simplified processes, centralized information with a single source of truth, saves time, and increases accuracy by reducing manual inputs. By automating processes, this reduces the total number of points of failure.
  3. Range of printing options – warehouses may need to print labels for cartons, pallets, individual items, or other items on paper or other materials. They may need to print directly onto products, or produce RFID tags, so they need a solution that offers all these options. Having the ability to print, mark, and code within a single labeling solution helps create a lean operation.
  4. Integration with WMS – much of the data needed for labeling is already held in the WMS. Integration allows this data to be pulled directly from the WMS onto the label, to eliminate data errors. This helps speed up information exchange between the systems and increases operator efficiency across the warehouse.
  5. Interoperability – the regulations demand that labeling information must be usable throughout the supply chain, so it’s essential to have a labeling solution that creates barcodes to GS1 standards.
  6. Printing security – labeling is designed to track goods to protect consumers, so the labeling system itself must be secure against unauthorized label changes or tampering. A labeling solution that offers document control, version control, and user-based security permissions creates the necessary barriers to ensure label prints are always authorized.
  7. Document storage and management – warehouses need to maintain an audit trail to abide by compliance laws, so they need a labeling solution that can store versions and consolidate labels in a centralized location.

Warehouses play an essential role in the protection and tracing of goods through the supply chain. They also have an obligation to keep their workers safe. Labeling is one of the key technologies that plays a vital role in helping them to meet both of these obligations. 

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