The European Packaging and Packaging Waste Regulation (PPWR), Regulation (EU) 2025/40, marks a significant step towards a more sustainable and circular economy. Applicable from 12 August 2026, it introduces a single harmonised regulatory framework for packaging placed on the EU market.

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What has changed?

The PPWR entered into force in February 2025 and will be phased in over the coming years. It replaces Directive 94/62/EC and introduces new requirements aimed at:

• Reducing packaging waste through reuse and recycling.

• Establishing standard requirements for packaging design and labelling.

• Increased responsibilities across the Supply Chain.

• Strengthening the requirements for environmental claims.

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Who needs to act?

This regulation affects all companies that place packaging on the EU market, including pharmaceutical and medical device manufacturers, including contract packagers, importers and distributors. ‍

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🚩 Goals and timelines

From 12 August 2026 - Application of the PPWR

• Extended Producer responsibility (EPR) includes registrations, contributions to waste management systems, and increased documentation and reporting obligations. Packaging fees will increasingly be linked to recyclability performance.

• Substances in Packaging - new requirements apply to packaging materials, including restrictions on heavy metals and PFAS in specific applications.

• Enhanced Documentation & Compliance for all manufacturers - technical documentation, conformity assessment procedures before placing packaging on the EU market, and an EU Declaration of Conformity (DoC) for each packaging type.

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August 2028

• Harmonised Labelling, QR codes, with material and recyclability information to provide transparency and enhance traceability.

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From 2030 - Key Sustainability Requirements Become Applicable

• Recyclability Requirements - 100% recyclable packaging. Only compliant products may be placed in the market.

• Minimum recycled content targets for plastics.

• Packaging Design adjustments (Minimisation) - weight, volume and empty space must be reduced to the minimum necessary without affecting product functionality and use.

• Begins waste reduction minimum targets (per capita) for all member states.

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From 2035 - Recyclability at Scale

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From 2040 - Enhanced Circularity Targets

• Stronger focus on reuse, digital labelling.

• Source recycled materials for the packaging that assure the target level of recyclability.

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Why does it matter for the pharmaceutical and medical devices sector?

The PPWR will require pharmaceutical and medical device companies to review packaging strategies and adapt to new sustainability and compliance requirements. Manufacturers remain ultimately responsible for demonstrating compliance through technical documentation, conformity assessments and EU Declarations of Conformity (DoC), even when supporting information is provided by packaging suppliers.

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Although the regulation recognizes the specific challenges associated with pharmaceutical and medical device packaging and includes certain exemptions for packaging in direct contact with products, secondary and tertiary packaging such as cartons, transport cases and pallet wrapping will generally need to comply with the new requirements.

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What are the operational and regulatory concerns?

• Packaging redesign for cartons, blisters, bottles, leaflets or others.

• Potential impact on stability studies and regulatory submissions.

• Additional documentation, compliance requirements, and artwork changes due to additional information required in labelling.

• New suppliers and packaging materials adding new qualifications, documentation and audits.

• Greater dependency on packaging suppliers to provide compliance, recyclability and material composition data.

• Risk of supply disruptions if transition is not well planned.

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Failing to prepare in time may result in compliance issues, supply disruptions, regulatory delays, increased costs and potential market access risks.

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With the PPWR application date fast approaching, organisations should already be assessing the impact on their packaging portfolios, proactively engaging with suppliers and defining their regulatory strategy. Take this opportunity to rethink your portfolio and use this change as a competitive advantage to remain in the market.

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