How Do I Stay Compliant with Packaging Regulations?

Why Packaging Compliance Matters

Packaging regulations exist to protect consumers, enable recalls, and keep supply chains transparent. Depending on your industry, "packaging compliance" can mean anything from printing an accurate lot number to embedding a GS1-compliant 2D barcode that carries expiration and serialization data.

Non-compliance carries real consequences, including:

• 1.
  Rejected shipments at the distribution center or retailer level
• 2.
  Regulatory fines and, in food and pharma, product recalls
• 3.
  Slower, less accurate recalls when traceability data is missing or unreadable
• 4.
  Lost retailer partnerships when barcode or labeling standards aren't met

Because requirements vary by industry, product, and destination market, the safest approach is to build compliance into the packaging line itself — not treat it as a final check before shipping.

Date Code and Lot Number Requirements

Date, lot, and batch information is one of the most commonly regulated elements of product packaging. Depending on your industry, this data may be legally required to support recalls, expiration tracking, and traceability.

What typically needs to be printed

• 1.
  Production date and/or expiration or "best before" date
• 2.
  Lot or batch number
• 3.
  Production facility or line code, in certain regulated sectors
• 4.
  Serial numbers for individually monitored units or shipping cases

In food, beverage, pharmaceutical, and cosmetics manufacturing, this information is often mandated by industry-specific regulations and must remain legible and accurate throughout the product's shelf life. Missing, smudged, or incorrect date and lot codes are among the most common causes of compliance failures and voluntary recalls.

Industrial inkjet, laser, and thermal transfer printers are commonly used to apply this information directly to primary packaging, cases, and pallets — a topic covered in more depth in our guide on inkjet printers for boxes.

Barcode and GS1 Compliance

Barcodes are the backbone of supply chain compliance, and the standards governing them are changing. The shift from traditional linear barcodes (like the UPC) to 2D barcodes, driven by GS1's Sunrise 2027 initiative, is one of the most significant packaging compliance changes manufacturers face today.

What 2D barcode compliance involves

• 1.
  Encoding batch/lot numbers, expiration dates, and serial numbers directly into a 2D barcode (such as a GS1 DataMatrix or QR code)
• 2.
  Maintaining backward compatibility with existing linear barcode scanning infrastructure during the transition period
• 3.
  Meeting barcode grading and print-quality standards so codes scan reliably at every point in the supply chain
• 4.
  Coordinating with retailers and distribution partners on their specific data and formatting requirements

For a full breakdown of 2D barcode requirements, retailer compatibility, and a manufacturer preparation checklist, see our dedicated GS1 Sunrise 2027 compliance guide.

Traceability and Recall Readiness

Traceability is what turns a coding system into a compliance system. Regulators and retailers alike expect manufacturers to be able to trace a product forward through distribution and backward to its raw materials and production run — often within hours, not days.

Many modern traceability regulations define specific information that must be captured as products move through the supply chain.

Key Data Elements (KDEs): The Information Behind Traceability

For manufacturers subject to traceability regulations such as FSMA 204, product tracking relies on Key Data Elements (KDEs), the information used to document a product's movement through the supply chain. These data elements are captured during Critical Tracking Events (CTEs) such as production, packing, shipping, and receiving.

Across different tracking events, KDEs generally fall into seven key categories:

• Traceability Lot Code (TLC) – the identifier linking a product to its traceability records.
• TLC Source – identifies where the lot code originated.
• Location Identifiers – where the product was produced, packed, shipped, or received.
• Dates – such as production, harvest, packing, or shipping dates.
• Product Description – information identifying the product.
• Quantity and Unit of Measure – how much product was involved in the event.
• Reference Documents – records that connect traceability data to business transactions.

Together, these data elements create the foundation of an effective traceability system, helping manufacturers improve recall readiness, simplify audits, and meet evolving regulatory requirements.

Building Recall-Ready Traceability

• 1.
  Assign a unique lot or batch code to every production run.
• 2.
  Link that code to production records: raw material lots, line, shift, and date.
• 3.
  Print the code accurately and legibly on primary packaging, cases, and pallets.
• 4.
  Verify the printed code matches the intended data before packaging leaves the line.
• 5.
  Maintain records in a system that can be queried quickly during an audit or recall.

Strict traceability regulations are especially prominent in food and beverage packaging, where a delayed or incomplete trace can extend a recall's scope and cost. Building traceability into your coding and inspection process — rather than reconstructing it after the fact — is the difference between a contained recall and a supply chain crisis.

Industry-Specific Traceability and Serialization Requirements

Serialization — assigning a unique identifier to individual units, cases, or pallets, is either required or increasingly expected across many industries.

• 1.
  Food and beverage: lot-level traceability tied to production runs, with growing adoption of item-level 2D codes for retailer and safety requirements.
• 2.
  Pharmaceuticals: unit-level serialization to support track-and-trace mandates and prevent counterfeit product from entering the supply chain.
• 3.
  Cosmetics and personal care: batch coding tied to ingredient and safety documentation.
• 4.
  Industrial and electronics: serialization for warranty monitoring, component traceability, and occasionally export compliance.

Since serialization specifications vary by product category and destination market, manufacturers distributing across multiple industries or territories frequently require packaging lines adaptable enough to implement different code formats and data configurations without compromising production speed.

Verification and Inspection Processes

Printing a compliant code is only half the job. Verification systems are a critical part of maintaining packaging compliance.

Standard verification and inspection approaches

• 1.
  Barcode verification systems that grade print quality against ISO/ANSI standards
• 2.
  Vision systems that confirm the printed date, lot, and code match the intended production data
• 3.
  Automated rejection systems that pull non-compliant packages off the line before they ship
• 4.
  Print-and-verify integration, so every unit is checked at the point of coding rather than sampled after the fact

Inspection becomes especially vital during transition periods — such as the migration to 2D barcodes — when existing and updated code formats may operate simultaneously, and error tolerance diminishes.

Automated verification identifies non-compliant packaging before it escalates into a rejected delivery or, more critically, a product recall.

Common Packaging Compliance Mistakes

• 1.
  Treating date/lot coding as a static print job instead of validating each print against production data
• 2.
  Delaying 2D barcode adoption until a retailer deadline forces a rushed changeover
• 3.
  Relying on manual visual checks instead of automated barcode grading and verification
• 4.
  Inconsistent code placement or format across packaging lines and facilities
• 5.
  Incomplete traceability records that slow down audits and recalls
• 6.
  Not accounting for how different retailers or markets interpret the same regulation

Building a Compliant Packaging Operation

Long-term packaging compliance comes from combining the right coding technology, the right verification systems, and the right internal processes:

• 1.
  Standardize your coding format across lines and facilities wherever possible.
• 2.
  Choose printing technology (inkjet, laser, thermal transfer) suited to your substrate, line speed, and code type.
• 3.
  Add inline verification so every code is checked, not sampled.
• 4.
  Build a data pipeline connecting production records to printed codes for fast traceability.
• 5.
  Plan for industry shifts, like GS1 Sunrise 2027, instead of reacting at the deadline.
• 6.
  Review labeling and coding requirements whenever you enter a new market or retailer relationship.

Stay Ahead of Packaging Compliance

Packaging regulations will keep evolving — new barcode standards, tighter traceability expectations, and industry-specific serialization mandates aren't slowing down. Manufacturers that build coding, traceability, and verification into their packaging lines now will adapt faster and ship with confidence, no matter what the next requirement is.

KEYENCE's coding, marking, and inspection systems help manufacturers meet packaging compliance requirements without slowing down production, from date and lot coding to 2D barcode printing, traceability initiatives, and automated verification.

Consult a KEYENCE specialist to find the right solution for your line.

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