The a2 Milk Company (ASX: A2M) Announces Major Pokeno Facility Approval for China Plans

In a key update for investors, The a2 Milk Company Limited (ASX: A2M, NZX: ATM) has achieved a significant regulatory milestone with the a2 Milk Company Pokeno approval process, securing two of three required clearances for its New Zealand manufacturing facility. The Ministry for Primary Industries (MPI) and General Administration of China Customs (GACC) have both granted approval ahead of the company’s internal expectations. This represents substantial progress towards manufacturing China-labelled infant formula under the a2MC brand at the Pokeno facility.

These approvals relate to two China label infant milk formula product registrations that a2MC acquired alongside the Pokeno facility. The registrations will be transitioned to a2MC-branded products following final regulatory clearance from China’s State Administration for Market Regulation (SAMR), which marks the final step in the approval pathway for the facility.

The company will submit its SAMR application in December 2025, with the review process anticipated to take approximately six months. Despite receiving the MPI and GACC approvals earlier than planned, a2MC maintains its commercial launch target of late 1H27 (first half of fiscal year 2027), demonstrating a measured approach to market entry that prioritises execution quality.

The Pokeno facility acquisition, which was completed on 1 September 2025, positions a2MC to control its China manufacturing supply chain directly. This important move addresses the world’s largest infant formula market, where securing owned manufacturing capability provides control over both production economics and market access.

CEO Commentary

The ASX announcement was authorised for release by the Board of Directors, with David Bortolussi serving as Managing Director and Chief Executive Officer.

The regulatory milestone significantly reduces execution risk surrounding a2MC’s manufacturing plans for China, with two-thirds of the approval pathway now successfully completed. Furthermore, owned manufacturing facilities combined with China registrations enable a2MC to capture substantially more value from China sales compared to third-party manufacturing arrangements, thereby improving the company’s margin profile in this key market.

What does the Pokeno facility approval process involve?

The a2 Milk Company Pokeno approval process requires clearance from three distinct Chinese regulatory agencies. This multi-agency framework emerged from China’s extensive regulatory overhaul following the 2008 melamine crisis, which reshaped infant formula oversight to prioritise quality and safety.

The Ministry for Primary Industries (MPI) serves as the first approval stage, certifying that New Zealand manufacturing facilities meet stringent production and safety standards. This certification confirms the Pokeno facility’s compliance with both New Zealand domestic requirements and international standards.

The General Administration of China Customs (GACC) provides the second approval layer, authorising the facility’s status for importing products into China. GACC approval enables physical product shipments to cross Chinese borders legally.

The State Administration for Market Regulation (SAMR) represents the final regulatory hurdle. For investors tracking this approval progress, SAMR provides clear visibility into the remaining regulatory steps and associated timeframes.

Regulatory Approval Timeline

How does SAMR approval complete the Pokeno approval pathway?

The State Administration for Market Regulation (SAMR) approval represents the final component of the a2 Milk Company Pokeno approval process. Without this registration, products cannot legally be sold to Chinese consumers regardless of manufacturing capability or facility certification already obtained.

SAMR’s role extends beyond simple product registration to include detailed oversight of brand identity, product formulations, packaging specifications, and marketing claims. The agency reviews scientific evidence supporting product safety and nutritional adequacy before granting approval.

The December 2025 submission timing positions a2MC to complete the SAMR review process by mid-2026, assuming standard processing timelines. This pathway suggests a2MC has prepared the necessary documentation and product specifications required for evaluation.

Successful SAMR approval will enable a2MC to utilise owned manufacturing for China sales, thereby improving its margin profile. Industry benchmarks indicate that owned facilities can deliver 10-15 percentage point EBITDA margin improvements compared to outsourced production arrangements, representing substantial financial benefits.

Three-Stage China Approval Process

What timeline should investors expect for commercial launch?

The full regulatory pathway from facility acquisition to commercial launch spans approximately 18 months based on a2MC’s disclosed timeline. The company acquired the Pokeno facility on 1 September 2025, with SAMR submission scheduled for December 2025.

Following SAMR submission, the six-month review process would deliver potential approval by mid-2026. However, the company’s commercial launch target of late 1H27 suggests an additional six to nine months is allocated for manufacturing scale-up, quality validation, and market launch preparation following regulatory approval.

This extended timeline reflects operational realities beyond simply receiving regulatory clearance. Manufacturing ramp-up requires production trial runs, quality assurance validation, and inventory accumulation to support a market launch.

a2MC’s timeline progression indicates conservative planning. The MPI and GACC approvals arrived earlier than the company’s internal expectations, yet management has maintained the original late 1H27 launch timeline. This approach prioritises execution quality over speed, allowing adequate time for manufacturing validation and market positioning activities.

Regulatory Pathway Timeline

This measured timeline underscores a focus on quality execution. For investors, the key takeaways are the significant reduction in regulatory risk and a clear path to capturing greater value from the Chinese infant formula market through owned manufacturing.

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