Imagine a world where every pill bottle, blister pack, and shipping box not only protects life-saving medications but also safeguards our planet. The EU PPWR , officially designated as Regulation (EU) 2024/1781, replaces the previous Packaging and Packaging Waste Directive 94/62/EC with a more harmonized approach to packaging sustainability.
The EU PPWR Regulation officially entered into force on February 11, 2025, replacing the previous Packaging and Packaging Waste Directive 94/62/EC with a more harmonized approach to packaging sustainability. Unlike its predecessor directive, which allowed for national variations in implementation, this regulation applies uniformly across all EU Member States, with a general application date of August 12, 2026.
The regulation’s core objectives are ambitious yet necessary: prevent and reduce packaging waste, make all packaging recyclable by 2030, boost recycled-content use, and harmonize rules EU-wide. The urgency is clear—packaging waste in the EU has surged by over 20% in the past decade, with projections estimating an additional 19% increase by 2030. Plastic packaging waste is expected to rise by 46%.
Recyclability Classification System
The EU PPWR introduces a comprehensive recyclability classification system that will fundamentally change packaging design decisions. The system operates in phases:
Phase 1 – Design for Recycling (2030):
By January 1, 2030, all packaging must be designed for recycling and achieve recyclability grades A, B, or C:
- Grade A: 95% recyclable content
- Grade B: 80% recyclable content
- Grade C: 70% recyclable content
Phase 2 – Recycled at Scale (2035):
From January 1, 2035, packaging must not only be designed for recycling but also be recycled at scale in real-world infrastructure.
Phase 3 – Enhanced Standards (2038):
From January 1, 2038, only packaging achieving Grade B (80%) or higher will be permitted on the EU market.
How EU PPWR Regulations Affects Pharma Packaging
Pharmaceutical packaging is no ordinary packaging. It must protect drugs from external factors such as sunlight and humidity while ensuring sterility, stability, and tamper resistance. At the same time, it must comply with strict regulatory requirements, including child-resistant features and safety standards.
- Contact-sensitive (Medicinal) Packaging: Medicines and medical devices often involve “contact-sensitive packaging,” meaning the packaging touches or contains the active product. PPWR explicitly delays many obligations for these cases. For instance, packaging for medicinal products does not have to meet the 2030 recyclability target until a review in 2035. Similarly, minimum recycled plastic content rules do not apply to packaging in direct contact with medicines. In simple terms, that means an inner blister pack or vial closure, where drug safety is paramount, isn’t forced to use recycled plastics by 2030. These exemptions are intentional: regulators acknowledge you cannot compromise patient safety. However, delayed obligations mean pharma companies have time to develop safe alternatives (such as compatible recyclable materials) for the future.
- Outer and Secondary Packaging: An outer cardboard carton, or the box used to bundle multiple prescriptions, generally must be recyclable by 2030 and fit the emptiness rules. In other words, the paperboard or plastic secondary pack around your blister will count as ordinary packaging. The PPWR emptiness rule caps “empty space” at 50% for grouped, transport, or e-commerce packaging by 2030. For pharma, this means shipping a batch of drugs in an oversized crate stuffed with bubble wrap is no longer acceptable. Companies should right-size boxes and avoid excess void-filling.
- Transport and Logistics Packaging: Pallets, crates, and reusable containers used between factories or for customer deliveries will face new requirements. By 2030, the reuse of transport packaging is encouraged: 40% of the packaging used to ship goods between companies or to customers must be reusable, and 100% reusable for internal transfers. Planning for reuse not only complies with EU PPWR but can improve efficiency.
- Recycled Content Targets: For most industries, PPWR sets rising minimum recycled plastic percentages (e.g., 30% PCR in PET bottles by 2030, 65% by 2040). Healthcare is again partially exempt: “contact-sensitive” plastics are exempted from these PCR mandates. In other words, companies don’t have to suddenly pack tablets in 30% post-consumer plastic tomorrow. But companies that use plastic parts that aren’t in direct contact (like shipping box stretch film, or plastic tubing outside the sterile region) must meet recycled content goals.
- Labeling and Transparency: PPWR introduces harmonized recycling labels. By 2028, every pack sold in the EU will need a visible label stating the material type and its recyclable fate. Some companies foresee adding QR codes on packaging to give sorting information to waste collectors.
- Extended Producer Responsibility (EPR): Pharma companies must cover the costs of collecting, sorting, and recycling their packaging waste. Fees are “eco-modulated,” meaning recyclable or lightweight packaging costs less, while heavy or complex materials cost more. Unlike recyclability exemptions, EPR applies to all pharma packaging.
Practical Steps Toward PPWR Alignment
How can pharmaceutical companies translate these challenges and opportunities into action? Here are strategic steps to start aligning packaging with the PPWR:
- Audit Your Packaging: Map all materials used in primary, secondary, and transport packaging. Identify hard-to-recycle items (e.g., multilayer blisters) and prioritize easier wins (e.g., recyclable cartons).
- Design-for-Recycling: Use single-material packaging, like mono-material blisters, to boost recyclability. Reduce the number of material layers in sachets, bottle caps, labels, and tubes. Switch adhesives and inks to ones that don’t contaminate recycling streams.
- Right-size and minimize: Reduce empty space and material weight. Implement the PPWR’s minimisation mandate by capping empty space at 50%. Use thinner walls or smaller bottle sizes where clinically acceptable. Right-sizing not only meets regulations but also cuts material use and shipping costs.
- Prepare for labeling and claims: Prepare for 2028 labeling requirements by designing space for recycling icons or QR codes. Avoid vague “green” claims unless backed by data.
- Engage with EPR authorities: Register with national EPR programs in each EU market. Track packaging data to simplify reporting and optimize designs to lower fees.
By acting early, pharma companies can reduce costs, enhance brand reputation, and lead in eco-friendly innovation, all while delivering safe medications to patients.
Conclusion
The PPWR represents more than regulatory compliance—it’s an opportunity to transform how the pharmaceutical industry thinks about packaging. It’s wise to track and implement the changes now. The goal isn’t to compromise on the quality or safety of pharmaceutical products, but to achieve these objectives through more sustainable means. With careful planning, strategic investment, and collaborative innovation, the pharmaceutical industry can successfully align its packaging strategies with the eu PPWR regulation while continuing to deliver life-saving medications to patients around the world.
How can DDReg Help?
DDReg offers comprehensive regulatory support across the entire product lifecycle in the EU—from regulatory strategy development and due diligence to new product authorizations, CMC advisory, and post-approval lifecycle management. Our team of experts provides up-to-date guidance on evolving regulatory requirements.
Whether you’re launching a new drug, managing post-market obligations, or navigating complex regulatory changes, DDReg provides the local insight and global perspective you need to succeed.
Read more about the EU’s Pharma market from our experts: Key Developments & Implications of the European Health Data Space
Reference –