Pharma packaging under PPWR: Safety and validation demands challenge compliance

Despite certain exemptions for pharmaceutical packaging under the EU’s Packaging and Packaging Waste Regulation (PPWR), as the August 12 deadline approaches, manufacturers must begin testing recyclable, high-barrier materials now while balancing circularity goals with patient safety and regulatory compliance, according to industry experts. 

Packaging Insights speaks to the European Federation of Pharmaceutical Industries and Associations (EFPIA) about the upcoming regulatory requirements, and to pharmaceutical packaging providers ACG World, based in Mumbai, India, and Plastic Ingenuity, based in Wisconsin, US, about their evolving strategy to service clients in the EU. 

“Pharmaceutical companies should continuously adapt and prepare for the changes embedded in PPWR due to long packaging change cycles and strict safety requirements. Specifically, companies should anticipate compliance with recyclable packaging provisions that will come gradually starting from 2028 but also packaging minimization provisions that will be applicable in 2030,” a spokesperson for EFPIA tells us. 

According to ACG Packaging Materials’ Jochen Scheil, VP Global Sales and Business Development and Dr. Sheikh Akbar Ali, head of Development and Technology: “The path forward requires proactive validation.” Pharmaceutical companies cannot wait until the 2030 deadlines to test new material, the experts warn. 

“Because changing a primary packaging material triggers a major regulatory variation filing that requires up to one to three years of real-time stability testing, the industry must begin trials of high-barrier, recyclability-optimized laminates and eco-grades immediately to safeguard access to the EU market.”

“PPWR provides exemptions for the direct-contact packaging of medical devices and medicinal products. The concern raised is the potential compromise to safety while complying with recyclability performance and minimum recycled-content requirements.”

Paige Greenberg, sustainable packaging engineer at Plastic Ingenuity, describes the designing of packaging for recyclability that incorporates post-consumer recycled (PCR) content without compromising the validated performance as “the biggest challenge” of PPWR compliance.

“Pharmaceutical and medical packaging often relies on specialized materials, barriers, coatings, or multicomponent structures to maintain validated performance. Simplifying those structures or changing a base material may improve recyclability, but it also requires extensive evaluation across the package’s full lifecycle, from manufacturing, sterilization testing, and transportation to meet regulations.”

Industry preparedness 

Pharmaceutical packaging companies should anticipate compliance with recyclability provisions starting from 2028, says EFPIA.Greenberg explains that August 12, 2026, marks the general application of PPWR, but is only the beginning of a longer implementation period. “Many of the technical criteria shaping packaging decisions are scheduled to be developed between now and 2030.”

“Design-for-recycling criteria are expected by 2028. Beginning in 2030, packaging placed on the EU market will generally need to be recyclable by design, and covered plastic packaging will face minimum recycled content requirements, subject to applicable exemptions and derogations. Packaging generally must achieve at least Grade C recyclability [according to EPR modulate fees] to remain compliant. Packaging below Grade C would not meet the market-access requirement.”

By 2035, packaging will also need to demonstrate that it is recycled at scale, she continues. 

“Beginning in 2038, Grade C packaging will no longer meet the market-access requirement, leaving only Grades A and B. Certain health care-related exceptions will also be reviewed as technology and recycling infrastructure evolve, reinforcing the need for companies to monitor the regulation.”

EFPIA’s spokesperson indicates that, in view of the upcoming August 12 deadline to comply with Declarations of Conformity, one of the biggest challenges is to collect the required data and documentation throughout the supply chains. “This is complex and involves numerous suppliers whose engagement is outside of our control.” 

“We regret the lack of clarity for the implementation of Article 12 on labeling requirements for medicinal products,” the spokesperson adds. “Given that pharmaceutical packaging and labeling are governed by sector-specific legislation and any changes generally require regulatory approval, sector-specific implementation guidance will be needed on how these requirements are expected to interact with existing medicines legislation.”

Medicinal products benefit from an exemption to the PPWR restriction on PFAS in food-contact packaging, the spokesperson continues. “However, food-contact compliance is commonly used as an important reference in the qualification of pharmaceutical packaging materials.”

“Clarification is therefore needed on how this may affect the continued acceptability of packaging materials currently qualified for pharmaceutical use under existing medicines guidance provided by the European Commission’s (EC) Directorate-General for Health and Food Safety and European Medicines Agency (EMA).

Exemptions and uncertainty 

The PPWR includes certain exemptions for medical and pharmaceutical packaging. ACG’s Scheil and Akbar Ali see the exemptions built into the EU regulation as a necessary “safety valve” for the medical supply chain. 

“However, these exemptions are highly targeted and often temporary, creating significant legal and technical grey areas for pharmaceutical manufacturers and packaging suppliers alike.”

“The PPWR offers a pragmatic balance between sustainability and patient safety. Its most significant exemptions protect direct-contact pharmaceutical packaging, acknowledging that packaging is an integral part of the medicinal product and cannot be changed without demonstrating safety and efficacy,” they continue.

“Nevertheless, the practical implementation of these exemptions remains an area where further guidance from the EC and competent authorities is needed. This includes the evidence required to justify them, their interpretation, and the future transition toward more recyclable pharmaceutical packaging.”

ACG warns that the industry must begin trials of high-barrier, recyclability-optimized laminates and eco-grades to safeguard access to the EU market.Plastic Ingenuity’s Paige explains that the PPWR includes targeted exemptions for certain immediate packaging of medicinal products and, in some cases, outer packaging where compliance with pharmaceutical legislation requires specific packaging characteristics to preserve product quality, safety, or efficacy. “However, these exemptions are limited and should not be interpreted as exempting all pharmaceutical packaging from PPWR.”

“This distinction is especially important for secondary packaging. Secondary packaging is generally more likely to remain subject to PPWR requirements because it is typically not in direct contact with the medicinal product and could present opportunities for material reduction, improved recyclability, and recycled-content integration.”

ACG and Plastic Ingenuity highlight that a lack of clarity surrounding the exemption persists.

Paige details: “Uncertainty remains around how companies will demonstrate that a specific package qualifies for an exemption and what technical documentation will be required.”

“Packaging will often need to satisfy PPWR requirements alongside pharmaceutical or medical device validation and change-control processes, so companies should not assume an exemption removes the need for technical assessment, documentation, or regulatory review.”

Balancing recyclability and sterility 

Pharmaceutical companies are balancing PPWR’s recyclability and material-reduction goals with the need to maintain sterility, barrier performance, and patient safety, ACG’s Scheil and Akbar Ali highlight. 

The PPWR is not a choice between sustainability and patient safety, they argue. “Instead, suppliers are pursuing a risk-based approach in which patient safety and regulatory compliance remain non-negotiable, while sustainability improvements are implemented wherever they do not compromise product quality.” 

“We see pharmaceutical companies navigating a delicate high-wire act. They must comply with the EU’s PPWR while strictly adhering to Good Manufacturing Practice (GMP) and EMA standards.”

Paige says that the most effective approach is to treat sustainability as part of the package-development and validation process rather than as a separate material substitution exercise. 

“At Plastic Ingenuity, we organize our PPWR readiness work around four design tenets: minimize substances of concern, minimize packaging (source reduction), design for recyclability, and increase recycled content and circularity.” 

“These principles must be evaluated alongside the package’s fundamental responsibilities. Material reduction cannot come at the expense of product protection, and a more recyclable resin is not a viable solution if it cannot withstand the required distribution, sterilization, or shelf-life conditions.”

Recycled content and recyclability 

Testing and documentation are essential to ensuring product protection, continues Paige. “Plastic Ingenuity works with customers to evaluate proposed materials and designs, complete the appropriate validation, and demonstrate that sustainability improvements do not compromise package performance.”

Plastic Ingenuity says sustainability should be part of the package-development process rather than a separate material substitution exercise.“For example, the development of our opaque PCR PET pharmaceutical clamshell compared several material pathways through a life-cycle assessment. The resulting package contains 75% PCR PET. Material trials and performance testing were then used to evaluate sterilization compatibility, durability, opacity, and product protection.”

To bridge the gap between circularity and patient safety, pharmaceutical companies are deploying a compliance strategy centered on structural innovation, risk assessment, and targeted optimization, according to Scheil and Akbar Ali. “ACG Packaging Materials is playing a major role on this path as a trusted pharmaceutical industry adviser.”

They say that pharmaceutical packaging companies are “aggressively” exploring technologies to develop products that do not compromise safety while following and complying with the PPWR guidelines. 

“This begins with design for recyclability. Monomaterial thermoformed blister packaging is one of the technologies being strongly pursued in this regard. The use of lighter materials, thereby reducing the contribution of packaging material, is another area that can contribute to the PPWR goals without compromising safety.”

Looking beyond August 12, the spokesperson for EFPIA says that pharmaceutical companies should continuously adapt and prepare for the changes embedded in PPWR due to long packaging change cycles and strict safety requirements. 

“Specifically, companies should anticipate compliance with recyclable packaging provisions that will come gradually starting from 2028, but also packaging minimization provisions that will be applicable in 2030.” 

“EFPIA member companies are fully committed to comply with PPWR in line with their sustainable commitments and their efforts to ensure the best possible care for patients. However, the abovementioned issues risk an inconsistent interpretation and implementation across EU member states, creating uncertainty for economic operators and potentially undermining the objectives of the regulation.”