PPWR compliance for healthcare packaging: no time to waste

The pharma industry has been down this road before.

A decade ago, a cascading set of geography-specific regulations led the industry to wonder aloud if, how and precisely when supply chain-traceability mandates would come into effect. As time went on and guidelines began to coalesce around foundational principles like unit-level serialisation and parent-child aggregation, the stasis of uncertainty quickly gave way to a sprint towards compliance. Amid the scramble to procure, install and validate serialisation systems and a whirlwind of updates and enforcement postponements, one takeaway became clear: ‘wait and see’ isn’t a strategy.

Today the industry finds itself staring down the barrel of another complex issue: the effort to make pharma and medical device packaging as sustainable as patient health and product efficacy allows. The Packaging and Packaging Waste Regulation (PPWR) is no longer a proposal at the edge of a long-range sustainability plan. Regulation (EU) 2025/40 entered into force in February 2025 and, as of this August, is now actively applicable. Its central direction dictates that packaging placed on the EU market must use fewer resources, become more circular and give end users more consistent sorting information for optimised recycling.

For pharmaceutical and medical device companies, however, the route is far from linear. Since packaging is part of a drug product or medical device’s overall safety system, environmental performance must be weighed against a set of elevated factors absent in other major industries. A blister package must control moisture, a sterile barrier must protect a syringe or other device and a carton must convey critical regulated information. Simply put, a package that isn’t viable is inherently unsustainable.

After years of uncertainty over healthcare exemptions, the finalised PPWR provides clarity concerning several key elements. And while various industry-specific allowances made the final cut, the enacted law is certainly not the sector-wide pass that some had initially hoped for. However incomplete, the industry now has marching orders that will help brand owners and packaging partners interpret requirements, redesign packaging when needed, and develop and hone evidence of compliance metrics.

Level setting: what PPWR exempts – and what it does not

Fortunately for clarity’s sake, PPWR’s final text is more precise than the shorthand often used in industry discussions. Primary packaging for drug products and contact-sensitive medical devices and in vitro diagnostics (IVDs) are excluded from recyclability requirements. Certain secondary drug packaging is also excluded in instances where meeting specific product preservation requirements takes precedence. However, the European Commission intends to review these exceptions by January 2035, meaning they should not be taken as a permanent reason to stop innovating.

Similar primary packaging exclusions apply to the minimum recycled-content obligations for drug products, contact-sensitive devices and IVDs. Here again, certain secondary pharmaceutical packaging also is exempt where necessary to preserve product quality. Secondary components that do not meet those definitions – as well as tertiary packaging like shipping cases, wraps and pallets – remain in PPWR’s scope unless expressly exempted.

Henceforth, marketing preference or consumer acceptance alone cannot justify extra material; at a minimum, explanatory documents will be pivotal.”

The pharma exemptions also do not erase minimisation requirements. Although PPWR recognises healthcare-specific concerns surrounding product protection, manufacturing, logistics, information, hygiene, safety and legal requirements, starting in January 2030 weight and volume must be reduced to the minimum necessary. While somewhat vague, in healthcare those criteria can encompass barrier performance, sterile integrity, tamper evidence, child resistance, traceability and mandatory information. Henceforth, marketing preference or consumer acceptance alone cannot justify extra material; at a minimum, explanatory documents will be pivotal.

In light of these issues, four main responsibility areas require expeditious attention:

Recyclability. Design-for-recycling criteria and “grades” (A, B and C) will begin governing market access in January 2030 or 24 months after the relevant acts enter into force, whichever is later. The “recycled at scale” condition follows in 2035, subject to the regulation’s timing mechanism. By 2038, non-exempt packaging must reach grade A or B. In doing so, packaging components – for example, a carton – must be evaluated as a system rather than individual elements.

Recycled content. Commencing in 2030 (or three years after the relevant implementing act takes effect, if later), PPWR Article 7 establishes minimum post-consumer recycled-content percentages for in-scope plastic packaging. These percentages will rise over the ensuing decade. Contact-sensitive packaging will be largely exempt from these minimums, but in-scope secondary and tertiary plastics will not. Manufacturers and importers will need technical information demonstrating compliance, supported by the EU’s calculation and verification methodology.

Minimisation. The question will no longer be merely whether a package is functional, but whether its weight and volume are the minimum necessary for it to work. Apparent empty space, thick walls, redundant inserts and oversized transport cases will need a defensible rationale backed by specifications, tests, studies, modelling or simulations.

Harmonised labelling. Material-composition labelling applies from August 2028 or 24 months after the relevant implementing acts take effect, whichever is later. Immediate and outer healthcare packaging is excluded when other EU-mandated information leaves no space, or when PPWR labelling could jeopardise safe use. Notably, that safeguard does not remove the need for an artwork impact assessment across cartons, labels and non-exempt distribution packaging.

Compliance is a development programme, not a checklist

Since PPWR has a specific goal –meaningfully enhancing the sustainability of packaging – each individual compliance obligation must be considered holistically. A pharma or med device package is, after all, an interdependent vehicle. A recyclable substrate may alter barrier, seal, sterilisation or line performance, and a lighter carton may fail compression testing. Recycled resin may vary in colour or mechanical properties, while a new visual symbol may compete with dosage, warning or multilingual information.

As in myriad other aspects of pharmaceutical and medical device production – eg, development, regulatory preparedness, clinical trial execution, large-scale manufacturing – complexity lends itself to collaboration.”

As in myriad other aspects of pharmaceutical and medical device production – eg, development, regulatory preparedness, clinical trial execution, large-scale manufacturing – complexity lends itself to collaboration. To firmly tie together the various threads involved with PPWR compliance, brand owners will invariably turn to expert partners like contract development and manufacturing organisations (CDMOs).

Consider a clinical-stage rare-disease therapy whose API is scarce and costly. Late packaging selection could leave the sponsor testing several systems with material it cannot afford to lose. A savvy CDMO partner can screen materials early, narrow candidates through modelling and platform knowledge, then focus on stability work. Such forethought can pay sizable long-term dividends: although primary pharmaceutical packaging is currently exempt, a future-ready design for circularity reduces the risk of redevelopment down the road.

Of course, packaging for in-market products must also be reassessed. For instance, a legacy moisture-sensitive tablet in a high-barrier blister should not be considered permanently exempt. Working with partners with experience handling similar applications can help a brand owner map the legal basis, retain stability evidence and assess whether secondary components can change without reopening the primary system. For a pipeline version, comparative permeation studies could test a mono-material format before pivotal stability commitments.

For a mature prefilled-syringe product, changing a thermoformed presentation tray to paperboard may reduce plastic and improve distribution density without changing the syringe’s immediate container. Of course, executing such a transition requires a lengthy list of tasks, including dimensional development, device retention and protection testing, usability review, transit testing, tooling and line trials, supplier qualification, artwork changes and formal change control. A genuinely novel packaging configuration might support its own utility or design patent strategy, but companies should not confuse possible packaging intellectual property with automatic extension of a drug patent or regulatory exclusivity. Here again, working with experienced partners can help bring clarity to opaque, situation-specific rules.

Recycled content creates a different sort of split-screen between investigational and commercialised products. A clinical team can specify compliant stretch film, pallet wrap or plastic transport components early and establish certificates and chain-of-custody evidence in the supplier package. By contrast, a legacy portfolio may require hundreds of packaging specifications to be segmented by exemption status, resin type, supplier and market. While the physical change may be modest, the data and governance burden most certainly is not.

Lightweighting and labelling follow a similar pattern. While a new product can establish material baselines and reserve artwork space before layouts are locked, a commercial product may need distribution requalification after board caliper is reduced, plus coordinated changes across multilingual stock keeping units.

In each of these cases, experienced CDMOs become far more than mere manufacturing vendors. Working across packaging, testing, labelling and distribution, CDMOs can connect decisions that otherwise sit in separate silos: classifying packaging levels, screening materials and suppliers, developing prototypes, running line and distribution trials, generating lifecycle evidence and assembling technical documentation. While CDMOs cannot replace brand owner accountability, they make the road to compliance substantially smoother.

Use case: a paperboard alternative with sustainability metrics throughout the packaging ecosystem

A screening lifecycle analysis supplied for a one-count prefilled-syringe presentation illustrates the value of system-level evaluation versus a fragmented box-checking approach. The comparison modelled the impact required to produce 30,000 items, weighing the benefits of a thermoformed concept against a paperboard construction comprising primary, secondary and tertiary packaging.

The paperboard design reduced total packaging weight from 29.52 to 26.13 grams per item – roughly 11.5 percent. The model also required approximately 278 tertiary packouts rather than 429 – a 35 percent reduction that points to better case utilisation. Across the cradle-to-grave screening model, it showed 36 percent lower fossil-fuel use, 13 percent lower global-warming potential, 21 percent lower water consumption with scarcity weighting and 20 percent lower mineral-resource use. Freshwater ecotoxicity fell 7 percent and the human-impact midpoint fell by 19 percent.

Sustainable design should not trade one headline metric for another without understanding the full profile.”

However, the result was not uniformly positive. Freshwater eutrophication increased slightly, by about 0.36 percent. While seemingly minimal, such pitfalls speak to a larger point: sustainable design should not trade one headline metric for another without understanding the full profile.

Importantly, the operational case must be proven alongside the environmental one. For a prefilled syringe, testing should confirm that paperboard retains and protects the device, withstands distribution, presents safely and runs reliably at commercial speed. Board sourcing, coatings, adhesives, printing, labelling, pack-out density and humidity performance also matter. Only when environmental, quality and operational evidence converge does a promising concept become a responsible commercial change. Functionality is a prerequisite to sustainability – especially in segments as mission critical as pharmaceuticals and medical devices.

Safety and sustainability: two sides of the same coin

PPWR brings a legislative deadline, but healthcare companies and their partners also share a moral obligation to reduce the burden of their products. That obligation is best served by disciplined decisions, not reactionary material swaps.

PVC illustrates the point. Many companies want to reduce or ultimately eliminate it when suitable alternatives are available. Until an alternative can provide the required barrier, machinability, supply continuity and validated product protection – and at a cost that aligns with pre-negotiated price points – the better answer may be to optimise gauge, secondary packaging, case packing, pallet pattern and distribution efficiency across end-to-end systems. A lower-impact total configuration can be more responsible than a nominally preferable substrate that increases rejects, product loss, freight requirements or quality risk.

The leaders in this transition will treat PPWR readiness as part of pharmaceutical and device development itself: define the legal pathway, design with circularity in mind, preserve patient protection, document the tradeoffs and use lifecycle evidence to improve the whole system. The regulation’s phases create ample time to act – but very little time to waste.

References

1. Regulation (EU) 2025/40 of the European Parliament and of the Council on packaging and packaging waste, especially Articles 6, 7, 10 and 12 and Annex IV: https://eur-lex.europa.eu/eli/reg/2025/40/oj/eng
2. European Commission. Packaging waste: https://environment.ec.europa.eu/topics/waste-and-recycling/packaging-waste_en
3. Packaging Efficiency - TF to Paper - 1ct Comparison, COMPASS screening life-cycle analysis, 11 June 2025 (supplied background document).