The EU Packaging And Packaging Waste Regulation: Why Life Sciences Companies Should Act Now

On 12 August 2026, the EU Packaging and Packaging Waste Regulation (Regulation (EU) 2025/40) (the “PPWR”) becomes applicable. It replaces the long-standing Packaging and Packaging Waste Directive with a directly applicable, EU-wide regime governing the design, documentation, labelling and end-of-life management of virtually all packaging placed on the EU market. Some in the life sciences field may assume that medical device, IVD and pharmaceutical packaging sits outside general packaging rules. That assumption is misguided: the PPWR applies broadly, and the sector-specific exemptions it contains are narrow and conditional.

Non-compliance is not a minor administrative matter. Packaging that does not meet PPWR requirements cannot lawfully be placed on the EU market, and life sciences companies that fail to act risk losing EU market access for their products, regardless of whether those products themselves hold valid CE Certificates of Conformity under the MDR, IVDR or marketing authorisation under applicable pharmaceutical legislation.

Life sciences companies are usually in scope

The PPWR applies to all packaging placed on the EU market, regardless of what it contains. A company does not need to manufacture packaging to fall within scope. The regulation’s concept of “manufacturer” captures the entity that places packaging, or a packaged product, on the EU market under its own name or trademark, which will frequently be the life sciences company itself rather than the entity that physically produced the box, carton or foam insert. Importers and distributors can also be pulled in, and in some cases reclassified as manufacturers, where they place packaging on the market under their own brand or modify it in ways that affect compliance.

Sector exemptions exist, but they are limited. Contact-sensitive packaging of medical devices and IVDs, and packaging in direct contact with medicinal products, may be exempt from certain sustainability requirements such as recyclability and recycled content. However, these carve-outs are specific, must be assessed product-by-product, and do not switch off the whole regime. They do not, for example, remove the core conformity documentation obligations, the substance restrictions, or extended producer responsibility.

Why act now

It seems likely that neither the authorities nor most companies will be fully prepared by 12 August 2026. National enforcement infrastructure is still being built, producer registers are not yet established in many EU Member States, and several implementing and delegated acts remain outstanding. That reality, however, is not a reason to wait, because pressure will likely to build first within supply chains with EU commercial customers resistant to accepting products with non-compliant packaging.

The legal obligation to place only compliant packaging on the market, supported by a Declaration of Conformity and technical documentation, applies from the application date regardless of the state of enforcement. Enforcement activity, being carried out at EU Member State level, can be variable, but companies should anticipate that it will start soon. Customs and market surveillance authorities can also request compliance documentation. Where that documentation is missing, the practical consequence is a market access risk: shipments can be delayed or held pending evidence of compliance. Being able to demonstrate that a credible compliance process is underway, with appropriate documentation and Declarations of Conformity being prepared per packaging type will allow companies to demonstrate due diligence, reassure customers, and minimise regulatory risk exposure.

The most pressing obligations: August 2026

Several foundational obligations apply from 12 August 2026 and should be the immediate priority:

• Conformity assessment and Declaration of Conformity. A conformity assessment must be carried out and a Declaration of Conformity drawn up per packaging type, following the model structure in Annex VIII, supported by a technical file.
• Substances of concern. The combined concentration of lead, cadmium, mercury and hexavalent chromium in packaging must not exceed 100 mg/kg. Supplier declarations will typically be needed as supporting evidence.
• Identification and traceability. Packaging must carry the required identification and traceability information, or provide it in accompanying documentation where the packaging does not allow.
• No misleading environmental claims. Packaging must not bear misleading sustainability, recyclability or reusability claims.
• Extended producer responsibility: the PPWR introduces a new harmonised producer-register obligation, but it depends on Commission implementing acts that have not yet been published. Existing national EPR schemes continue to apply in the meantime and should be mapped per EU Member State.

What comes later

Many of the more demanding technical requirements apply on later, phased deadlines. These include:

• Around August 2028: harmonised material composition labelling, once the relevant implementing acts are adopted.
• From 2030: recyclability performance grading, minimum recycled content targets for plastic packaging, packaging minimisation and empty space limits, and reuse targets for certain packaging formats.

These later obligations depend heavily on delegated and implementing acts that are still to come, so the sensible approach is to build the compliance architecture now and refine the technical assessments as the detailed rules are published.

Practical takeaways

For life sciences companies, the key message is that the PPWR very likely applies to your packaging, the sector exemptions are narrower than might be optimistically assumed, and the August 2026 obligations are documentation-heavy rather than design-heavy. Starting now, by mapping packaging types, confirming economic operator roles, and preparing Declarations of Conformity, is the most effective way to protect EU market access, reassure customers and minimise regulatory risk.

We are advising a range of pharmaceutical, medical device, IVD and general consumer product companies on PPWR readiness, and will continue to monitor developments, including the outstanding implementing and delegated acts, as the regime takes shape.