PPWR: Why Pharma Packaging Is Not Exempt

"Pharma is exempt from PPWR." We hear it in almost every scoping call. It is also the assumption most likely to fail a packaging audit. The Packaging and Packaging Waste Regulation (PPWR, Regulation (EU) 2025/40) has been in force since 11 February 2025 and enters general application on 12 August 2026. It covers all packaging placed on the EU market, not only consumer goods, but equally pharma, biotech, MedTech and IVD. The exemption many companies rely on does exist. It is simply much narrower than the sentence implies.

The Article 6(11) exemption is narrow

The much-cited safety exemption sits in Article 6(11) PPWR. It removes the recyclability requirements from the immediate packaging as defined in Directive 2001/83/EC and Regulation (EU) 2019/6 (that is, the packaging in direct contact with the medicinal product) as well as the outer packaging where that packaging is necessary to preserve the quality of the medicine. It is meant for blister packs, vials, ampoules and prefilled syringes: packaging where switching to a recyclable design would compromise sterility, barrier properties or product stability.

The framing matters. The exemption applies primarily to the design-for-recycling obligation under Article 6 and is conditional: the packaging must be directly product-protecting. It is not a blanket pass for "everything around a medicine," and it does not extend to the packaging levels surrounding it.

Cartons, leaflets and outer packs: exempt only under one condition

Everything beyond the product-protecting packaging falls within the full scope of the PPWR. That includes:

• the folding carton (secondary packaging) in which blisters or vials are shipped,
• the patient leaflet and other printed inserts,
• bundled and grouped packs for hospital or wholesale quantities,
• the tertiary and transport packaging: outer cartons, trays, shrink wrap, pallet securing.

For these levels the exemption applies only where the outer packaging is necessary to preserve the quality of the medicinal product (Article 6(11)(d)). In practice that does not carry for most of the carton volume. They must meet the core obligations of the PPWR, and this is exactly where the effort sits that the "we are exempt" assumption keeps out of view.

Four obligations land on your packaging

For the levels that are not exempt, four families of obligation apply, each on its own timeline.

• Recyclability (Art. 6). Packaging must meet "design for recycling." The phased performance grades apply from 1 January 2030 (design assessment against recyclability grades); from 1 January 2035 packaging must be recycled "at scale" through established infrastructure; from 1 January 2038 the grade A/B threshold takes effect. All three are minimum dates: the regulation ties each of them to "or 24 months, respectively five years, from the entry into force of the corresponding delegated and implementing acts, whichever is the latest".
• Recycled content (Art. 7). Plastic packaging carries binding minimum recycled-content shares from 1 January 2030, with higher thresholds from 2040. Contact-sensitive packaging of medicinal products is subject to its own special provisions, yet evidence of the recycled-content shares still has to be produced for the secondary and tertiary levels.
• Packaging minimization (Art. 10). Packaging must be reduced to the minimum weight and volume necessary for function and safety; unnecessary empty space and multiple layers of packaging now need justification.
• Harmonized labeling (Art. 12). From 12 August 2028 the EU-wide harmonized labeling on material composition and disposal applies. For pharmaceutical artwork this means coordinated changes to layouts that are already under tight regulatory constraints. This date, too, applies "or 24 months from the entry into force of the implementing acts, whichever is the latest".

Why this is a supply-chain program, not a labeling update

Scheduling the PPWR as a mere labeling change underestimates it. The critical path is the packaging supply chain. Making a folding carton recyclable, or proving a recycled-content share, means in practice: specifying material, requalifying suppliers, testing samples, running change control and updating the technical documentation. That is not a quarter, it is a program.

Then there is the cross-functional logic. It touches Regulatory Affairs (labeling, marketing-authorization variations), Quality Management (change control, specifications), Packaging Design and the CDMO or supplier side at the same time. These functions have to move in sync, otherwise you land in exactly the situation that makes the 12 August deadline uncomfortable: renegotiating supplier contracts under time pressure.

One more scheduling factor: ten days before the PPWR deadline, on 2 August 2026, the EU AI Act transparency obligations under Art. 50 took effect. The high-risk obligations come later; Regulation (EU) 2026/1744 moved them to 2 December 2027 (Annex III) and 2 August 2028 (the product path under Art. 6(1)). For companies with both software and packaging exposure, two regulatory dates therefore fall in the same month.

What to do now

The sensible move is a PPWR packaging scoping that prioritizes by packaging level and remaining time. Concretely:

• Clarify scope. Sort the portfolio by packaging level and record honestly where the Article 6(11) exemption really applies and where it does not. In practice, most of the packaging volume falls within full scope.
• Assess gaps. Hold recyclability, recycled content, minimization and labeling against the PPWR requirements level by level, and review the technical documentation.
• Plan the supply chain. Set up packaging-supplier requalification, artwork and change-control adaptation, and CDMO coordination as a dedicated work package with realistic lead time.

Entourage supports pharma, biotech, MedTech and IVD companies in determining the PPWR scope for their own portfolio and closing the four obligations across the affected packaging levels: from scope assessment through recyclability and recycled-content assessment to coordinating packaging suppliers and CDMOs. The starting point is usually a gap read that records which levels are in scope and in what order they become robust ahead of 12 August 2026.