In August 2026, the European Union’s (EU's) Packaging and Packaging Waste Regulation (PPWR) took direct effect across all member states. Claudia Anzaldo, senior regulatory labelling manager, and Véronique Boscher, regulatory affairs manager at ICON plc discuss.
ICON plc
The regulation introduces major changes to how packaging must be designed, labelled and managed across all sectors in the EU, aiming to improve sustainability, reduce waste and harmonise packaging rules.
Unlike some past EU environmental measures, the PPWR deliberately keeps pharmaceuticals and medtech in scope, recognising their complexity but granting only narrow, health-and-safety-based exemptions rather than blanket relief. For these sectors, this is not a sustainability afterthought. It is a regulatory obligation that touches product safety, patient access and supply chain continuity. Understanding the PPWR’s requirements and how to respond to them will be critical to staying in compliance.
Key components of the PPWR
There are three primary dimensions of the PPWR:
- Sustainable packaging. Sustainable packaging. The first strategic area of focus is the set of requirements that packaging must meet to remain compliant and eligible for the EU market. The PPWR introduces a broader sustainability framework covering recyclability, the presence of substances of concern such as PFAS, the minimisation of packaging weight and volume and minimum recycled-content requirements for plastic packaging. For pharmaceutical and medical device companies, these requirements are particularly significant because packaging design is closely linked to product protection, sterility, stability and patient safety. This may limit the extent to which conventional packaging materials and formats can be redesigned solely on environmental grounds. Importantly, packaging that is intended to come into contact with medicinal products or medical devices is provisionally exempt from certain recyclability and recycled-content requirements. Nevertheless, companies should not view these exemptions as removing the need for action: they will need to assess where requirements apply across their packaging portfolios, anticipate future regulatory developments and identify opportunities to reduce material use and environmental impact without compromising product integrity or regulatory compliance.
- Labelling, marking and information. New requirements for harmonised labelling are intended to support consumer sorting. These requirements prioritise making composition and reusability information accessible and easy to understand, including the use of pictograms, QR codes and standardised digital marking. This creates both a compliance challenge and a strategic opportunity: companies will need to review how packaging information is designed, positioned and managed across markets, while ensuring that new environmental information does not compromise the visibility or integrity of legally required product information.
- Technical, digital and implementation rules. The regulations establish expectations for implementing new packaging requirements and sustainability claims. Among other specifications, they prohibit misleading claims, standardise claims for biobased and recycled content and define label placement and visibility.
Impact on pharma and medtech companies
Given the sensitive nature of pharmaceutical and medical technology products, changes to packaging requirements have far-reaching ramifications. Potentially, the composition of packaging and labels will materially change, requiring the redesign of a variety of components, such as cartons, blister packs, bottles and leaflets. These changes are complicated by the need to maintain good manufacturing practices, stability and patient safety across all elements. Additionally, introducing sustainability information to already crowded and constrained packaging materials, especially secondary packaging, will increase artwork complexity and pressure across EU markets.
The PPWR will also affect supply considerations. Packaging suppliers will need to undergo requalification and audits to ensure products are compliant with PPWR regulation. High demand as new requirements take effect will limit the availability of compliant materials, even while pharma and medtech companies become more dependent on suppliers that satisfy requirements. Together, these pressures will increase change management and supply risk. Companies will need to manage longer timelines, parallel packaging versions during transition and potential supply disruption when changes are not planned and synchronised early.
A final consideration is increased regulatory complexity. Because pharmaceutical and medtech packaging often comes in close contact with safety-critical products, any redesigns may trigger variations, stability studies and a higher regulatory workload. For example, pharma products and medical device packaging are often part of the validated product system and changes to it will lead to risk assessments, packaging and transport validation, shelf-life assessments and updates to technical documentation to demonstrate that product safety, performance and sterility are not adversely affected. This, in turn, will increase operational costs, driven by higher compliance demands and the need for centralised packaging data governance.
Strategies moving forward
Companies should consider PPWR an end-to-end transformation across the full product lifecycle, not a sustainability-only initiative or regulation. Integrating its requirements across development, labelling, supply and post-market stages is the best way to ensure a strategy that satisfies regulatory expectations and adapts as needed.
One of the most important actions is to assess PPWR early, such as by conducting portfolio-wide packaging audits or identifying high-risk SKUs and constrained formats. This allows companies to align changes with regulatory submission cycles to reduce risk, cost and supply disruption, which is particularly critical given long regulatory and supply chain lead times. Companies should engage suppliers and partners proactively to enable compliant materials, justified exemptions and smoother implementation.
Companies should also ensure the proper infrastructure to support PPWR changes. One way to do this is by strengthening cross-functional governance and collaboration across regulatory affairs, quality, packaging engineering and sustainability departments. These groups will likely need to work closely together to ensure the proper implementation of new packaging requirements. Another consideration is digital and data infrastructure, including robust packaging data management systems, centralised data governance, QR code integration and digital labelling capabilities, to facilitate and support compliance.
Continued regulatory evolution
The implications of PPWR will continue to shift in the coming years, as new deadlines come into effect and current elements (such as the exemption of contact-sensitive primary packaging from recyclability and content requirements) are scheduled to be reassessed. Pharma and medtech companies must look ahead: Preparing for early alignment will be a significant asset in staying ahead of supply chains and remaining in compliance with changing expectations.