PPWR: Why Pharma Packaging Is Not Exempt

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"Pharma is exempt from PPWR." That sentence is only partly true. The Packaging and Packaging Waste Regulation (PPWR, Regulation (EU) 2025/40) has been in force since February 11, 2025, and enters general application on August 12, 2026. It covers all packaging placed on the EU market, not only consumer goods, but equally pharma, biotech, medical devices and IVD. The exemption 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 comply with specific requirements to preserve the quality of the medicinal product. It is meant for blister packs, vials and ampoules: packaging where switching to a recyclable design would compromise sterility, barrier properties or product stability.

The framing matters. The exemption only concerns the recyclability requirements under Article 6, and its reach depends on the packaging level: immediate packaging is exempt as such, outer packaging only where it is necessary to comply with specific requirements to preserve the quality of the medicinal product (Article 6(11)(a) and (d)). It is not a blanket pass for "everything around a medicine."

Cartons, grouped and transport packaging: where the exemption ends

Everything beyond the immediate packaging falls within the full scope of the PPWR. That includes:

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

The exemption in Article 6(11)(d) covers only the outer packaging as defined in Article 1, point (24), of Directive 2001/83/EC, that is, the packaging in which the immediate packaging is placed, such as the folding carton, and even that only where it is necessary to comply with specific requirements to preserve the quality of the medicinal product. For grouped packs and for tertiary and transport packaging, Article 6(11) contains no exemption for medicinal products; point (f) exempts only packaging used for the transport of dangerous goods under Directive 2008/68/EC. Where no exemption applies, these levels 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.

In our reading, an ordinary patient leaflet placed loose in the pack serves the legally required information on the medicinal product and is therefore, as a rule, not to be classified as packaging under the PPWR. The Regulation contains no express clarification on this. Documents or information carriers that also perform a packaging function need a separate assessment.

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 be designed for recycling. The phased performance grades apply from January 1, 2030 (design assessment against recyclability grades); from January 1, 2035, packaging must be recycled at scale through established infrastructure; from January 1, 2038, packaging may be marketed only if it reaches grade A or B (Art. 6(3)). The first two dates are minimum dates: 2030 applies or, if later, 24 months after the delegated acts on design for recycling enter into force; the recycled-at-scale requirement applies from 2035 or, if later, five years after the corresponding implementing acts. The regulation contains no such clause for 2038, so that date is fixed. The basic requirement of Art. 6(1), that all packaging placed on the market must be recyclable, carries no deadline of its own; in its Notice C/2026/3084 (section 6), the Commission reads it as applying since August 12, 2026, with only Directive 94/62/EC and the related harmonized standards required until the design-for-recycling criteria under Art. 6(2)(a) apply. The Notice is a non-binding interpretation. Art. 6(10) provides a special derogation for innovative packaging. In addition, the specific exemptions under paragraph 11 apply.
• Recycled content (Art. 7). Plastic packaging carries binding minimum recycled-content shares from January 1, 2030 (or, if later, three years after the implementing act on the calculation methodology), with higher thresholds from January 1, 2040. Art. 7(4) has its own list of exemptions, which does not coincide with Art. 6(11). It covers immediate packaging of medicinal products, outer packaging where necessary to comply with specific requirements to preserve the quality of the medicinal product, contact-sensitive plastic packaging of medical devices and IVD, and packaging of supplies and components for the manufacture of medicinal products where the quality standards of the medicinal product require it. Individual plastic parts that make up less than 5% of the total weight of the whole packaging unit are also exempt from the minimum recycled-content shares (Art. 7(5)(b)). For secondary and tertiary plastic packaging that falls under none of these exemptions, evidence of the shares still has to be produced.
• Packaging minimization and empty space (Art. 10, Art. 24). By January 1, 2030, the manufacturer or importer must ensure that packaging is designed so that its weight and volume are reduced to the minimum necessary to ensure its functionality (Art. 10(1)). Art. 24 makes this concrete for empty space, in two stages. By February 12, 2028, economic operators who fill sales packaging (such as the folding carton around a blister or vial) must ensure that empty space is reduced to the minimum necessary for the packaging functionality, including product protection. For products that settle during transport, for food where headspace is needed to protect it, and for other products that present these characteristics, Art. 24(4) provides two allowances: compliance is assessed at the pack-fill level at the time of filling, and air between or within packed foodstuff and protective gases do not count as empty space. Article 24(4) does not expressly name pressure-sensitive products. The special assessment rules apply to medicinal-product packaging only where the products concerned actually present these or comparable characteristics. Independently of that, the empty space needed for the packaging function and for product protection can be taken into account. There is no blanket relief for medicinal-product cartons. For grouped, transport and e-commerce packaging, the economic operators who fill it must ensure by January 1, 2030, or three years after the entry into force of the implementing acts on the calculation methodology, whichever is later, that the empty space ratio does not exceed 50%, defined as the ratio of the empty space (the difference between the total volume of the grouped packaging and the volume of the sales packaging it contains) to the total volume of the grouped packaging. Filling materials such as air cushions, foam or wood wool count as empty space. Economic operators who use sales packaging as e-commerce packaging, or who use reusable packaging within a system of re-use, are exempt from this 50% obligation (Art. 24(5)); they must nevertheless ensure that such sales packaging meets the requirements of Art. 10. What matters for pharma: the Article 6(11) exemption does not apply here. It is limited to Art. 6 and leaves Art. 10 and Art. 24 untouched, including for contact-sensitive primary packaging.
• Harmonized labeling (Art. 12). From August 12, 2028, or 24 months after the implementing acts enter into force if that is later, EU-wide harmonized labeling on material composition and disposal applies. For pharmaceutical artwork this can mean coordinated changes to layouts that are already under tight regulatory constraints. Two limits narrow the effect. Art. 12(11) exempts immediate packaging and outer packaging of medicinal products, medical devices and IVD from the whole article where there is no space on the packaging because of other labeling requirements, or where the labeling could jeopardize the safe use of human or veterinary medicines. And in its Notice C/2026/3084 of June 10, 2026 (section 13), the Commission reads Art. 12(1) as not applying to packaging of medicinal products, medical devices and IVD that can only be used by professional end users in the course of their industrial or professional activities. For medical devices and IVD it understands immediate packaging there as the packaging in contact with the device and outer packaging as the sales packaging. The Notice is an interpretation and not binding; binding interpretation rests with the EU Court of Justice alone. For packaging supplied to consumers or patients, the applicable labeling obligations under Art. 12 apply unless one of the provided exemptions applies. For packaging of medicinal products, medical devices and IVD that may be used exclusively by professional end users, the Commission's reading of Art. 12(1) must be considered as well.

Pharmacies may be distributors too: Art. 19

The PPWR does not mention pharmacies expressly. Its definitions, however, also reach the last stage of the supply chain: Article 3(1), point (18), defines the distributor, and point (21) expressly the final distributor, who delivers packaged products to the end user. A pharmacy that dispenses industrially packaged medicinal products to patients can therefore fall under these definitions.

Before making packaging available on the market, Article 19(2) requires distributors, among other things, to verify that the producer subject to extended producer responsibility is registered in the register of producers under Article 44 and that the packaging is labeled in accordance with Article 12. The product-specific exemptions have to be considered. Where a distributor has reason to believe that the packaging is not in conformity, the conditions of Article 19(3) must be examined. Article 19(3) does not cover the registration under Article 44: it ties the bar on making packaging available to non-conformity with Articles 5 to 12 and to the duties under Article 15(5) and (6) and Article 18(3). Where a label required under Article 12 is missing and no exemption applies, the distributor may not make the packaging available until it has been brought into conformity. The labeling duty under Article 12(1), however, applies only from August 12, 2028, or 24 months after the implementing acts enter into force if that is later.

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 August 12 deadline uncomfortable: renegotiating supplier contracts under time pressure.

One more scheduling factor: ten days before the general application of the PPWR, on August 2, 2026, the transparency obligations of the EU AI Act under Art. 50 became applicable in principle. For certain AI systems marketed earlier, Art. 50(2) is subject to a transition period until December 2, 2026. The high-risk obligations come later; Regulation (EU) 2026/1744 moved them to December 2, 2027 (Annex III) and August 2, 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.
• Assess gaps. Hold recyclability, recycled content, minimization including the empty space ratio (Art. 24), 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, medical device 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 a gap analysis that documents which requirements apply to which packaging level, where action is needed, and by which of the respective applicable deadlines the necessary measures must be implemented.

Image notice: The images in this article were generated using artificial intelligence. They do not depict real people, places, or events.