Question 1

Is pharma packaging exempt from the PPWR?

Accepted Answer

No, not across the board. The Article 6(11) exemption of the PPWR (Regulation (EU) 2025/40) concerns in particular the immediate packaging of medicinal products, for example blister packs, plus the outer packaging where it is necessary to preserve medicinal-product quality. Cartons, bundled and transport packaging are in principle subject to the PPWR requirements; the relevant exemptions have to be examined separately. An ordinary, loosely enclosed package leaflet serves the medicinal-product information required by law and is in principle not packaging. The PPWR does not say so expressly.

Question 2

What does the Article 6(11) PPWR exemption actually cover?

Accepted Answer

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, plus the outer packaging where it is necessary to preserve product quality. It is tied to Art. 6 and is not a blanket pass for every packaging level. Recycled content (Art. 7(4)) and labeling (Art. 12(11)) have their own exception lists, worded differently from Art. 6(11).

Question 3

From when do the PPWR obligations apply to pharma, biotech, medical device and IVD packaging?

Accepted Answer

The PPWR has been in force since February 11, 2025, and has applied generally since August 12, 2026. For the packaging concerned, staggered application dates follow: the recyclability grades and the first minimum recycled-content shares apply from January 1, 2030, at the earliest, the requirements on recycling at scale from January 1, 2035, at the earliest, and harmonized labeling under Art. 12 from August 12, 2028, at the earliest. These dates can move later, depending on when the relevant delegated or implementing acts enter into force. For the grade A/B threshold from January 1, 2038, and the higher minimum recycled-content shares from January 1, 2040, by contrast, the PPWR provides no such automatic postponement clause. The basic requirement in Article 6(1) that all packaging placed on the market shall be recyclable carries no deadline of its own; the Commission reads it in its Notice C/2026/3084 (section 6) as applying since August 12, 2026, and, until the design-for-recycling criteria under Article 6(2)(a) start to apply, as requiring only compliance with Directive 94/62/EC and the related harmonised standards. The Notice is a non-binding interpretation. The applicable exemptions still have to be taken into account.

Question 4

Are the PPWR deadlines of 2028, 2030, 2035 and 2038 fixed?

Accepted Answer

Not all of them. The 2038 and 2040 dates carry no automatic postponement clause. The 2030 and 2035 dates for recyclability (Art. 6), the 2030 date for recycled content (Art. 7) and the 2028 date for labeling (Art. 12) apply on the date shown or, if later, a set period after the corresponding delegated or implementing acts enter into force (24 months, three years or five years, depending on the provision). They can therefore move outward, not inward. The January 1, 2038, date for grade A/B (Art. 6(3)) and the January 1, 2040, date for the higher recycled-content shares (Art. 7(2)) carry no such clause.

Question 5

Why is PPWR compliance a supply-chain program rather than a labeling update?

Accepted Answer

Because the critical path is the packaging supply chain: making a carton recyclable, or proving a recycled-content share, means specifying material, requalifying suppliers, testing samples, running change control and updating the technical documentation. That cannot be scheduled within a single quarter and has to run in sync with Regulatory Affairs and Quality Management.

Question 6

Does a separate PPWR rule apply to empty space in medicinal-product packaging?

Accepted Answer

Yes, Art. 24 PPWR. For sales packaging, such as the folding carton around a blister or vial, empty space must be limited to the minimum needed for product protection and function by February 12, 2028. Art. 24(4) makes allowances for products that settle during transport, for food where headspace is needed to protect it, and for other products that present these characteristics (pack-fill level at the time of filling; air 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. The empty space needed for the packaging function and for product protection can be taken into account independently of that. There is no blanket relief for medicinal-product cartons. For grouped, transport and e-commerce packaging, the empty space ratio must not exceed 50% by January 1, 2030, or three years after the corresponding implementing acts enter into force, whichever is later, 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. Filler counts as empty space. The Article 6(11) exemption does not apply here, it is limited to Art. 6.

Question 7

Does the PPWR also affect pharmacies directly?

Accepted Answer

The PPWR does not name pharmacies expressly. It does, however, define both the role of the distributor (Art. 3(1), point (18)) and that of the final distributor, which delivers packaged products to the end user (Art. 3(1), point (21)). A pharmacy that dispenses industrially packaged medicinal products to patients can therefore fall under these definitions. Where pharmacies act as distributors, the relevant verification duties under Art. 19 apply. They include the registration of the producer subject to extended producer responsibility under Art. 44, compliance with the applicable labeling requirements under Art. 12, and certain identification obligations of manufacturers and importers. The applicable statutory exemptions have to be taken into account. Where there are reasonable doubts about the conformity of the packaging, the conditions for a ban on making it available under Art. 19(3) have to be examined.

Question 8

Who is manufacturer, producer, distributor or importer for the folding carton, grouped and transport packaging?

Accepted Answer

The PPWR assigns roles by person and activity, and it separates two levels. The manufacturer (Art. 3(1), point (13)) is whoever manufactures the packaging or the packaged product, or has it designed or manufactured under its own name or trademark; it is responsible for conformity with Art. 5 to 12 (Art. 15). The producer (point (15)) is whoever makes the packaging or the packaged product available for the first time on the territory of a Member State; it carries extended producer responsibility there and has to register under Art. 44. For products you make in house under your own brand, your own company is the manufacturer, and the same applies to contract manufacturing under your own brand (point (13)(a); point (13)(b) covers micro-enterprises). In the Commission's non-binding reading, the trademark owner remains the manufacturer even if another company does the filling. Without a trademark, the same reading makes the manufacturer whoever orders the packaging and decides its specifications, which for generic transport packaging is normally the company that physically makes it (Notice C/2026/3084, section 2; Commission FAQ, chapter II, questions 5 and 6). A company that passes on goods under someone else's brand is a distributor (point (18)), or an importer for goods from a third country (point (17)). Either counts as manufacturer if it places packaging on the market under its own name or trademark or modifies it in a way that could affect compliance (Art. 21). A company that unpacks packaged products without being an end user can be the producer of that packaging (point (15)(e)). For enclosed items, function under Art. 3(1), point (1), decides; as an example, Annex I lists a device for measuring dosage that forms part of the container closure for detergents as packaging.

Question 9

Does the PPWR also apply to supplies between sites and companies of a group?

Accepted Answer

Yes, the PPWR has no group exemption. Making available covers any supply in the course of a commercial activity, whether in return for payment or free of charge (Art. 3(1), point (9)), and each group company is a legal person of its own. If one company supplies packaged goods to a sister company in another Member State that makes them available there for the first time, the sister company is the producer there (point (15)(b); for the transport packaging point (15)(a) or, if it unpacks, point (15)(e)). The Regulation also applies within a single company: bought-in transport packaging used to ship parts between its own sites counts as placed on the market according to the Commission FAQ, whereas packaging the company makes itself and that has never been part of a commercial transaction is not covered (chapter II, question 13). For the site matrix, this means that supply relationships within the group belong in the rows as well.

Question 10

Do the PPWR exemptions apply differently at a site with medicinal products, medical devices, food supplements and cosmetics?

Accepted Answer

Yes. The exemptions for health products depend on product category and packaging level, not on the site or the packaging line. Art. 6(11) names the immediate packaging of medicinal products, their outer packaging where it is necessary to preserve quality, and contact-sensitive packaging of medical devices and in vitro diagnostic medical devices. Art. 7(4) (recycled content) has its own, differently worded list; Art. 12(11) (labeling) applies only where there is no space or labeling could jeopardize safe use. Food supplements and cosmetics are named in none of the three provisions; their packaging is subject to recyclability, recycled content and labeling without these exemptions. Their plastic packaging in contact with the product is contact-sensitive (Art. 3(1), point (49)) and carries its own recycled-content shares under Art. 7(1) and (2); the Commission FAQ lists transport wrapping film as not contact-sensitive (chapter V, question 5). For medical devices, the Commission wants "contact-sensitive" understood for Art. 7 in the same way as immediate packaging, which is in direct contact with the product (FAQ chapter V, question 9). The sterile barrier system, which Annex I expressly lists as packaging, is in contact with the product; it falls under Art. 6(11)(b) and, where made of plastic, under Art. 7(4)(b). The same folding carton from the same supplier can therefore be subject to different obligations depending on the product. For borderline products, the classification of the product comes first.

Question 11

What can realistically be clarified in the first month for a large portfolio?

Accepted Answer

The order of work, not the whole portfolio. Products with the same category, the same packaging type and the same destination countries are combined into groups; each group is classified once and cross-checked against individual products. First come the groups without an exemption and with the largest volume, and the data gaps that hold up several groups at once. At the end of the first month it is clear which groups are classified, which information is missing and who supplies it by when.

How do pharma, biotech, medical device and IVD companies manage the PPWR (Regulation (EU) 2025/40) without overreading the Article 6(11) exemption?

Why does PPWR compliance become a supply-chain program for pharma and MedTech?

How we support you

PPWR Scoping & Exemption Assessment

Recyclability & Recycled-Content Assessment

Supplier Requalification & Change Control

Implementation at the Site

What it comes down to

Our approach

Where projects commonly fail

PPWR Scope Check

Do any of these pitfalls apply to you?

Frequently asked questions

What we have worked on in this industry

Annex 1 Compliance in Sterile Manufacturing

Audit Software Integration for Improved Production Quality under GMP

PPWR: Why Pharma Packaging Is Not Exempt

Regulations & standards considered

Related topics

Have a concrete project?

How do pharma, biotech, medical device and IVD companies manage the PPWR (Regulation (EU) 2025/40) without overreading the Article 6(11) exemption?

Why does PPWR compliance become a supply-chain program for pharma and MedTech?

How we support you

PPWR Scoping & Exemption Assessment

Recyclability & Recycled-Content Assessment

Supplier Requalification & Change Control

Implementation at the Site

What it comes down to

Our approach

Where projects commonly fail

PPWR Scope Check

Do any of these pitfalls apply to you?

Frequently asked questions

Is pharma packaging exempt from the PPWR?+

What does the Article 6(11) PPWR exemption actually cover?+

From when do the PPWR obligations apply to pharma, biotech, medical device and IVD packaging?+

Are the PPWR deadlines of 2028, 2030, 2035 and 2038 fixed?+

Why is PPWR compliance a supply-chain program rather than a labeling update?+

Does a separate PPWR rule apply to empty space in medicinal-product packaging?+

Does the PPWR also affect pharmacies directly?+

Who is manufacturer, producer, distributor or importer for the folding carton, grouped and transport packaging?+

Does the PPWR also apply to supplies between sites and companies of a group?+

Do the PPWR exemptions apply differently at a site with medicinal products, medical devices, food supplements and cosmetics?+

What can realistically be clarified in the first month for a large portfolio?+