Saudi SASO Updates Cold-Chain Label Standard for Optical PET Film

Saudi Standards, Metrology and Quality Organization (SASO) issued Amendment 1 to SASO/IEC 60601-2-24:2026 on May 29, 2026, introducing a new mandatory requirement for optical PET film labels used in pharmaceutical cold-chain transport: no cracking or delamination after ISO 12019 bend testing at −40°C. Effective September 1, 2026, the update directly affects all suppliers exporting medical-grade label films to Saudi Arabia.

Event Overview

On May 29, 2026, SASO published Amendment 1 to SASO/IEC 60601-2-24:2026. The amendment adds a compulsory low-temperature performance criterion for optical polyethylene terephthalate (PET) film labels intended for pharmaceutical cold-chain applications. Specifically, such labels must withstand ISO 12019-standardized bending tests at −40°C without visible cracking or layer separation. The requirement enters into force on September 1, 2026, and applies to all optical PET film label products supplied to the Saudi market for medical cold-chain use.

Industries Affected by This Update

Export-oriented label film manufacturers

Manufacturers supplying optical PET film labels to Saudi healthcare logistics providers or medical device packagers are directly subject to compliance. Non-conforming products will fail SASO certification or market access review post-September 2026. Impact manifests in product qualification timelines, testing documentation requirements, and potential revalidation of existing label constructions.

Raw material suppliers (e.g., PET resin, adhesive, topcoat formulators)

Suppliers providing base resins, pressure-sensitive adhesives, or surface coatings for cold-chain labels may face revised technical specifications from downstream converters. The −40°C bend resistance requirement places new constraints on polymer crystallinity, adhesive tack retention, and interfacial adhesion stability—factors that influence raw material selection and formulation validation.

Label converters and contract packagers

Converters producing finished labels for pharmaceutical shippers must verify that their full stack—including film substrate, adhesive, liner, and print layer—passes the ISO 12019 bend test at −40°C. This may necessitate process adjustments (e.g., corona treatment levels, drying parameters) and updated quality control protocols for low-temperature performance verification.

Distribution and regulatory compliance service providers

Third-party testing labs, SASO certification consultants, and import documentation agents serving label exporters will need to align their service offerings with the new test protocol. Demand is likely to rise for accredited −40°C bend testing per ISO 12019 and supporting technical dossier preparation for SASO submission.

Key Considerations and Recommended Actions for Stakeholders

Monitor official SASO guidance and implementation clarifications

SASO has not yet published detailed test procedure interpretations, sampling rules, or transitional arrangements. Exporters should track SASO’s official portal and authorized conformity assessment bodies for updates on acceptable test laboratories, certificate validity periods, and grandfathering provisions for existing certified labels.

Validate label performance across the full supply chain—not just substrate alone

The requirement applies to finished labels, not raw PET film alone. Companies must test assembled labels (film + adhesive + liner + print) under actual storage and handling conditions replicating −40°C exposure followed by mechanical deformation. Relying solely on material datasheets or supplier declarations is insufficient for compliance.

Distinguish between regulatory signal and enforceable obligation

This amendment is a formal regulatory revision—not a draft proposal or industry recommendation. Its inclusion in SASO/IEC 60601-2-24:2026 signals binding technical enforcement. However, enforcement readiness (e.g., customs inspection protocols, market surveillance frequency) remains subject to SASO’s operational capacity and may evolve gradually after September 2026.

Initiate internal readiness assessments before Q3 2026

Given typical lead times for material requalification, test lab scheduling, and SASO documentation review, affected companies should complete gap analyses by July 2026. Prioritize labels with high export volume to Saudi Arabia and those already deployed in ultra-low-temperature logistics (e.g., mRNA vaccine distribution).

Editorial Perspective / Industry Observation

Observably, this amendment reflects SASO’s increasing alignment with global pharmaceutical logistics standards—particularly those emphasizing physical durability under extreme thermal stress. Analysis shows it functions less as an isolated technical tweak and more as a signal of tightening regulatory convergence around cold-chain integrity verification. From an industry perspective, the focus on bend resistance—not just peel adhesion or thermal shrinkage—highlights growing attention to mechanical reliability during real-world handling (e.g., pallet stacking, container loading, freezer door impacts). Current evidence suggests this requirement is now codified and enforceable; however, its broader adoption across other Gulf Cooperation Council (GCC) markets remains unconfirmed and requires separate observation.

This update marks a step toward harmonized performance expectations for medical labeling in ultra-low-temperature environments. It does not introduce new testing infrastructure globally, but it does raise the bar for verification rigor in one key export market. For stakeholders, it is best understood not as a sudden disruption—but as a targeted, technically grounded calibration of existing cold-chain label requirements in Saudi Arabia.

Source: Saudi Standards, Metrology and Quality Organization (SASO), SASO/IEC 60601-2-24:2026 Amendment 1, published May 29, 2026.
Further developments—including SASO’s official interpretation documents and enforcement guidance—remain under observation.