See What’s Possible in Life Sciences Packaging @ PACK EXPO International
2,600 exhibitors. 150+ free educational sessions. See packaging solutions for life sciences & more @ PACK EXPO International, Oct 18-21 in Chicago
REGISTER NOW & SAVE

Create a free Healthcare Packaging account to continue reading

PPWR Is Here: What Packaging Teams Need to Do Now

With the EU’s Packaging and Packaging Waste Regulation entering its first phase, healthcare packaging companies face new compliance expectations—and decisions that shouldn’t wait.

Ad Lpm Eu Pharmaceutical Vaccine 4096x4096 72dpi
Avery Dennison

The EU's Packaging & Packaging Waste Regulation (PPWR) officially began implementation on August 12 and requires packaging teams to develop cross-functional compliance strategies, conduct portfolio assessments, and engage suppliers to meet phased requirements while addressing misconceptions about exemptions and regulatory responsibilities.

  • PPWR implementation started August 12 as one of the most comprehensive packaging sustainability regulations ever enacted, replacing fragmented national requirements with a harmonized EU framework.
  • Cross-functional teams including packaging engineers, sustainability teams, regulatory teams, and suppliers are essential to assess compliance and develop effective roadmaps.
  • Healthcare packaging has specific exemptions for immediate pharmaceutical packaging and contact-sensitive medical device packaging, but exemptions don't provide blanket protection and may be reassessed in 2035.
  • Four critical steps for compliance include analyzing materials for restricted substances, evaluating recyclability impact, simplifying packaging structures, and improving technical documentation and traceability systems.
  • Brand owners and packers bear primary responsibility for compliance, not suppliers alone, requiring clear role clarification across the supply chain.

Nearly two years since becoming an official law, the European Union (EU) Packaging & Packaging Waste Regulation (PPWR) entered implementation Aug. 12. Regarded as one of the most comprehensive packaging sustainability regulations ever enacted, PPWR is intended to establish a harmonized framework for packaging and packaging waste.

According to the European Commission, the regulations mark a major step to reducing waste and compliance costs, creating more sustainability to the waste value chain while minimizing dependence on imports of virgin materials, strengthening the market for secondary raw materials, and supporting the transition to a competitive circular economy and climate neutrality by 2050. As a replacement for what has systemically been considered fragmented national requirements, PPWR is also intended to bring consistency to rules that address the entire packaging life cycle. While the mandates will be fully implemented through a phased approach that will span many years to allow various stakeholders to meet compliance in stepwise fashion, guidance is still necessary to assist in its adoption.

“From our perspective, there is a growing sense of urgency,” says Gerald Rebitzer, sustainability and advocacy lead for Europe and Asia at Amcor. “Increasingly, companies recognize that packaging decisions influence current and future extended producer responsibility costs, recyclability performance, access to markets, and overall regulatory readiness. Many larger organizations have been assessing their portfolios and engaging suppliers for some time, while some companies are still working through the regulation’s scope, documentation requirements, and phased implementation.” Rebitzer and other industry experts say that developing an appropriate roadmap during this early portion of the regulatory process will be key to improving the integrity and safety of packaging across the various domains covered by PPWR. 

Developing Your PPWR Strategy

Given the complexity of PPWR’s scope, a high-level approach to achieving and maintaining compliance can begin with establishing a cross-functional team among packaging engineers, sustainability teams, regulatory teams, and suppliers, says Paige Greenberg, sustainable packaging engineer at Plastic Ingenuity.

“The regulation is forcing companies to evaluate their packaging systems and the sustainability of their packaging systems from the start when they're picking their materials,” says Greenberg. “It encourages sustainability and circularity in packaging to be addressed from the nucleation of a package or the idea phase rather than just looking at sustainability and waste as an end-of-life issue.”

Taking a cross-functional approach will help companies remain in position to assess compliance through ongoing tracking and classifying of inventory to analyze current portfolio options against upcoming PPWR requirements for identifying potential areas that could warrant change. “Also, working with a knowledgeable and trusted supplier can help with developing a strategy or roadmap, and then designing and implementing any changes needed,” says Greenberg.

Healthcare Product Example 1Plastic IngenuityPPWR requirements present additional oversight for healthcare packaging manufacturers because of how various specialty materials play critical roles in sterility maintenance, product protection, barrier performance, and packaging durability, says Greenberg, who suggests a four-step approach to evolving restrictions and reporting requirements: 

1.     Analyze materials that might contain substances receiving increased scrutiny, such as barrier coatings, adhesives, inks, multilayer structures, and heavy metals.

2.     Evaluate how materials could impact recyclability, recycled resin quality, and waste stream contamination.

3.     Identify opportunities to simplify packaging structures and reduce use of unnecessary chemical complexity.

4.     Improve technical documentation, material traceability, and digital reporting systems to improve transparency around additives, coatings, and other areas for disclosures.

According to Robin Cote, product manager at Avery Dennison Materials Group, packaging companies should consider a variety of steps to help minimize disruption and facilitate the PPWR transition, including: 

  • mapping out packaging formats and components to identify which elements are included in PPWR scope and which benefit from specific derogations;
  • reviewing label compatibility to assess how utilized materials impact packaging end-of-life;
  • confirming whether suppliers can provide data needed for compliance through documentation, including information on substances of concern, recycled content, and recyclability; and
  • determining whether internal systems require updates to collect data, track packaging metrics, or fulfill reporting and documentation obligations to prepare for reporting and registration measures.

Addressing Misconceptions

Despite the well-plotted compliance pathway, some of PPWR’s technical standards are still being finalized, which has resulted in uncertainty, says Rebitzer. “That is why companies should be focusing first on portfolio assessments, supplier engagement, and building documentation and compliance processes that will be needed as additional requirements come into force,” he says.

Common areas of confusion also include exemptions and special considerations for certain pharmaceutical and medical packaging applications, provisions that Rebitzer says should be viewed as an opportunity to plan as opposed to an excuse to delay. As of mid-September, PPWR exempts certain healthcare packaging from mandatory recyclability requirements including immediate pharmaceutical packaging, contact-sensitive packaging for medical devices and in vitro diagnostic devices, and packaging for dangerous goods transportation covered under Article 6 and Article 7.  

“Contact-sensitive” generally refers to packaging that directly impacts sterility, biocompatibility, contamination prevention, product safety, and validated performance, according to Greenberg. “But a package having exemptions does not give a blanket exemption from PPWR as a whole,” she says. “And just because your package is exempt today doesn't mean you are safe forever. As technology improves and the European Commission reassesses exemptions, they could go away.”

Current exemptions also might not apply to secondary or tertiary healthcare packaging. Packaging that doesn't directly interact with a pharmaceutical product or a medical device, which includes non-contact thermoforms, protective packaging, and transportation or distribution packaging systems, are not covered by the exemption either. European Commission officials will reportedly reassess exemptions as of 2035. 

Another misconception is that suppliers alone are responsible for compliance, explains Rebitzer. “Responsibility generally lies with the economic operator placing the packaged product on the EU market, often the brand owner or packer/filler, although the precise role can depend on the supply chain,” he says. “Our recommendation is to assess packaging by application and type, clarify the role of each economic operator, and monitor official EU guidance as it develops.”

One complicated exemption nuance is that specific derogations from design-for-recycling (DfR) requirements exist for the immediate packaging of medicinal products and for recycled content targets regarding contact-sensitive plastic packaging of medical devices, according to Cote. “But not every pharmaceutical package qualifies for such exemptions,” he says. “If the outer packaging is not required to preserve product quality, the DfR and recycled content requirements apply. In order to avoid those confusions, packaging manufacturers can consider auditing their portfolios in order to assess which packaging components are likely to fall in scope of the PPWR or may benefit from a derogation.”

See What’s Possible in Life Sciences Packaging at PACK EXPO International
Explore new machinery & materials from 2,600 exhibitors. Gain insights from 150+ free educational sessions. Find solutions to tackle the toughest challenges—for life sciences & beyond—at North America’s largest packaging & processing event.
REGISTER NOW & SAVE
See What’s Possible in Life Sciences Packaging at PACK EXPO International
Fresh from the show floor: pharma packaging innovations for 2026
Serialization mandates. Containment demands. Sterile barrier requirements. Our editors found the pharma packaging innovations addressing your biggest challenges at PACK EXPO Las Vegas. Get your free curated report now.
GET YOUR COPY
Fresh from the show floor: pharma packaging innovations for 2026