Regulatory Labelling Compliance

PDC Marketing
Jul 22, 2024
2 min read

Trade is accelerated by consistency in information exchange. If both parties know when, how, and where money and information will be exchanged, the transaction happens more rapidly.

Product labelling is the universal methodology for information exchange on shipped goods. Consistency in labelling can be achieved by regulatory agencies creating policies, global organizations developing worldwide standards, or even a dominant player taking the lead in dictating standards others adopt as well.

Non-compliance with these standards can result in fines, returned shipments, audits, and additional time spent transporting, receiving, and processing goods. Delays of this sort are not readily accepted in a world already struggling with logistics constraints.

Below is a sampling of the various compliance requirements, and the benefits of TSC Printronix Auto ID printers in generating compliant labels.

Labelling mandates and compliance tend to fall into the following categories:

Serialisation

Ensuring each device has a unique serial number for tracking and, if needed, recall. The objective is to ensure no missing or duplicate serial numbers, and that the serial number clearly marked on the item. Please see our solutions in this area in collaboration with software partners for unique serialization. Examples of serialization regulations include:

Unique Device Identification (UDI) Labeling

The US Food and Drug Administration (FDA) requires that all medical devices distributed in the United States be labelled with a Unique Device Identifier (UDI).

UID (Unique Identification) and Item Unique Identification (IUID) Labeling Compliance

The US DoD and NATO specified unique ID requirements including MIL-STD-129P and MIL-STD-130.

Drug Supply Chain Security Act (DSCSA)

The US Food and Drug Administration (FDA) specifies label and serialisation requirements for drugs.

Label Content

These compliance requirements include specifying format, content, barcode symbology, and required elements or symbology on the label. Please see our comprehensive range of printer solutions with a wide range of printer-language emulations and advanced print functions to provide support for a wide range of label sizes, substrates, and data streams. Examples of content regulations include:

Globally Harmonized System (GHS) Labeling

The Globally Harmonized System of Classification and Labeling of Chemicals (GHS) was enacted to improve safety and protect the health of workers within the chemical industry.

US Healthcare Label Compliance

The US Food and Drug Administration has specified requirements for label format and content, including FDA 21 CFR Part 11, HIBC, HIBCC, ICCBBA, GUDID, blood bag labels, and biologic sample labels.

European Union Medical Device Regulation (EU MDR) Labeling

The EU MDR is designed to ensure public health and safety across Europe and to increase the quality and transparency of medical devices through label design, approval, and tracking standardization.

GS1 Labeling Compliance

GS1 barcodes are a de facto worldwide standard used for traceability of logistic units including GS1-128, GS1-Datamatrix, GS1-Digital Link, and SSCC.

Food Labeling Compliance

Requirements for food labelling include the Food Safety Modernization Act (FSMA), EU Regulation 1169/2011 on the Provision of Food Information to Consumers (FIC), Produce Traceability Initiative (PTI), and US Food and Drug Administration requirements for nutrition labels, alcoholic beverage labels, and food allergen labels.

Automotive Compliant Labeling

Mandated content and format labels for incoming goods including AIAG, GM, Odette, VDA, and GTL.

Transportation Industry Compliance

Compliant labels within the transport industry include SSCC, UPD, USPS, Walmart, and SSC14.

Airline Industry Compliance

Airline industry-compliant labelling includes mandates from ATA Spec 2000, International Air Travel Association (IATA), Boeing, and Airbus.

Telecommunication Industry Compliance

Compliant label requirements within the telecommunications industry include the Telecommunications Industry Forum (TCIF) and TLC39.

Retail Industry Compliance

Specifications for label content and format come from large US retailers, including Amazon, Walmart, Target, Hudson Bay, Macy’s and others.

Environmental Labels

Specifications for label content, symbol inclusion, and format include EU Energy Label and Energy Star.

Media Specifications

In addition to label content, physical attributes such as label size, substrate, colour, and material may also be mandated by regulatory agencies, industry groups, or industry leaders.

Readability Metrics

A perfectly designed label printed on the compliance material will fail absolutely if the information on the label cannot be read. The American National Standards Institute (ANSI) defined a barcode grading schema adopted by the International Standards Organization (ISO) as ISO-15415 for 2D barcodes and ISO-15416 for 1D barcodes. Regulations or customers not only define label content and material but also minimum ISO grades for barcode readability.

Please read about our solutions for integrated barcode validation and verification. Providing the easiest solution to implement without external scanners, PCs, templates, or operator intervention, every barcode on every label on every job will be found, read, and graded. The grading report is available for archival to defend against chargebacks or fines.

Additional Compliance Resources: