What Is the PPWR (EU Packaging and Packaging Waste Regulation)? Its Impact on the Pharmaceutical Cold Chain and Temperature-Controlled Shipping Containers

We are hearing more and more from shippers who move temperature-sensitive pharmaceuticals and specimens to the EU: "I've heard a new packaging regulation called the PPWR is starting — will the insulated containers we use be covered?" The honest answer is this: the PPWR only began to apply in full in August 2026, and while some parts clearly affect cold-chain shipping containers, many of the detailed rules are still being worked out on the EU side. This article looks at the PPWR from the perspective of temperature-controlled transport — what is already known, what is still uncertain, and what Japanese shippers should be doing now.

What Is the PPWR (EU Packaging and Packaging Waste Regulation)?

The PPWR (Packaging and Packaging Waste Regulation) is Regulation (EU) 2025/40, a new EU law that covers all packaging placed on the EU market and requires waste reduction and the promotion of recycling and reuse. It replaces the former Packaging and Packaging Waste Directive (Directive 94/62/EC); it entered into force on 11 February 2025 and began to apply generally on 12 August 2026.

The key point is the shift from a "Directive" to a "Regulation." A directive must be transposed into each country's national law, which creates variation; a regulation applies directly across the entire EU, imposing the same rules on all 27 member states at once.

Its scope is broad: in principle all packaging is covered regardless of material, and not only those who make packaging but also those who manufacture, import, or distribute packaged products. Japanese companies exporting to the EU are not outside this framework.

The PPWR Is Still "Finding Its Feet" — Practical Rules Remain Unsettled Even After It Started

"Applies from August 2026" may sound as if every requirement switches on at once, but in reality the PPWR is a long timeline that phases in from 2026 through 2040. Many of the specific criteria that will govern day-to-day practice are left to delegated and implementing acts still to be issued.

Even at the point of application, several delegated acts defining technical criteria remain unfinalized, and thresholds such as those for recyclability are still provisional. Harmonised label designs, design-for-recycling criteria (the delegated act is due by January 2028), and an EU-wide producer registration system (expected in 2029) are among the higher-profile requirements whose application has been pushed further out.

This uncertainty has been flagged by the EU's own industry: ahead of the application date, industry associations noted that the level of uncertainty across the supply chain had reached a critical point. The sensible stance on the ground is simple — act now on the obligations that are fixed, while following the latest information on the criteria that are not yet settled. This "prepare while you wait" approach is the most rational one right now.

Are Cold-Chain and Temperature-Controlled Shipping Containers Covered by the PPWR?

Requirement	When it applies	Relevance to cold-chain containers
Restrictions on substances of concern (four heavy metals, PFAS, etc.)	From 12 Aug 2026	Affects the material composition of containers and materials
General packaging-minimisation duty	From 12 Aug 2026 (calculation method pending future acts)	Review of excess cushioning and empty space
Minimum number of rotations for reusable packaging	Delegated act expected Feb 2027	Directly relevant to passive reusable containers
Harmonised labelling	From 2028 (pharma packaging partly exempt)	Possible review of outer labelling
Design-for-recycling criteria & recycled content	Criteria 2028 → applies 2030	Affects container material design

Two Alternatives to Expanded Polystyrene — Reusable Containers and Renewable Materials

What the PPWR encourages is a clear direction: from single-use toward reuse and recycling. In temperature-controlled transport, the way to respond to this trend splits broadly into two, depending on how you ship.

The first is reusable containers. TCC (Tower Cold Chain), which Hubnet handles, is a reusable bulk container suited to large, regular shipments, and it answers the regulation's push to "use again" directly.

The second is renewable materials that replace expanded polystyrene (EPS) boxes. GreenTherm, from Intelsius and handled by Hubnet, is an insulated material for smaller shipments made from renewable paper-based material; it delivers performance on par with EPS (maintaining −20°C for 96 hours) while being 100% recyclable. It suits smaller shipments where you want to move away from single-use EPS packaging.

Reusable containers for large shipments, and a recyclable EPS alternative for small ones. These two options cover most temperature-controlled transport needs in a PPWR-ready form.

What Japanese Shippers Should Do Now

Even while the full picture of the PPWR is still fluid, there is preparation you can start today. The practical points for shippers moving temperature-sensitive goods to the EU are these four.

1. Take stock of EU-bound shipments: identify the products and volumes you send into the EU and the packaging (outer packaging, insulated containers, materials) you use.

2. Confirm the Declaration of Conformity (DoC) with your container suppliers: ask the makers of the insulated containers and materials you use about their PPWR compliance status and whether they can provide a Declaration of Conformity. Moving early is an advantage.

3. Understand your current material composition: know the materials in your containers and consumables (presence of heavy metals, PFAS, etc.).

4. Separate "act now" items from "await confirmation" items: proceed on requirements that already bite, such as substance restrictions, and keep following those still to be finalized, such as labelling and design-for-recycling criteria.

The one that pays off most is item 2, confirming the DoC with suppliers. Even shippers who do not make their own containers can, by having the maker's compliance status on hand, respond quickly when an EU counterpart asks about compliance.

With Preparation, Regulation Becomes a Tailwind — GDP-Certified Transport with an Eye on the PPWR

You may think, "That's a European matter." But environmental and ESG expectations spread across borders, and major Japanese shippers will move in the same direction with a lag. Both TCC and GreenTherm have global supply networks, so even if the trigger is the EU, the benefits reach Japanese business too. This regulation is a headwind if you are unprepared and a tailwind if you are.

Hubnet's pharmaceutical transport brand THERMAL™ is a specialist division for temperature-controlled transport with GDP (Good Distribution Practice) certification. From our GDP-certified warehouse in Heiwajima, we can advise end to end — from selecting reusable containers and renewable materials to designing GDP-compliant transport. For container selection for EU-bound temperature-controlled shipments, or packaging with the PPWR in mind, please get in touch.

Frequently Asked Questions (FAQ)

Q. I've heard pharmaceuticals are exempt from the PPWR — is that true?

The exemption for pharmaceutical packaging is limited to certain requirements, such as harmonised labelling, and relates mainly to primary packaging. It does not take you out of the regulation as a whole: outer packaging such as insulated shipping boxes, PCM, and cushioning can be covered by many requirements. A requirement-by-requirement check is needed.

Q. When does the PPWR apply?

It entered into force on 11 February 2025 and began to apply generally on 12 August 2026. Not every requirement switches on at the same time, however: labelling applies from 2028, and design-for-recycling criteria and recycled-content rules are set for 2028 (criteria) and 2030 (application), with a phase-in running through 2040.

Q. Which is more PPWR-friendly — reusable or single-use containers?

Because the PPWR is aimed at the transition to a circular economy, reusable containers and renewable EPS-alternative materials are the favoured direction. A practical split is reusable containers (TCC) for large, regular shipments and renewable insulated materials (GreenTherm) for small ones.

Q. Do Japanese companies need to comply?

Yes. The PPWR applies to every operator that places packaging or packaged products on the EU market, including importers and distributors. Japanese companies exporting to the EU also need to confirm that their packaging meets the requirements.

Contact

For advice on container selection for EU-bound temperature-controlled transport, or on switching packaging with the PPWR in mind, please feel free to contact us.

This article is provided for general information only and does not constitute legal advice. The PPWR is at a stage where delegated and implementing acts are being issued in sequence, and the details of requirements may change. For compliance decisions in individual cases, please consult the latest official guidance or a specialist.