Life sciences products impacted by new EU packaging rules

Hayden Morgan and James Hay of Pinsent Masons were commenting after the first raft of updated requirements provided for under the EU's Packaging and Packaging Waste Regulation (PPWR) began to apply on Wednesday.

For life sciences companies that manufacture, import or distribute pharmaceutical products, medical devices, diagnostics, consumer health products or laboratory supplies in the EU, compliance with the PPWR is necessary to ensure products can continue to move through supply chains unimpeded, they said.

The PPWR became EU law in February 2025, but its provisions only take effect in stages, starting from 12 August 2026. The regulation replaces the previous EU PPW Directive, which was implemented differently by EU member states. The new framework establishes a systematic set of packaging rules across the EU with the goal of reducing packaging waste and improving sustainability across the packaging lifecycle.

The PPWR sets out mandatory sustainability requirements covering packaging materials, design and recyclability. It also imposes restrictions on the use of so-called ‘forever chemicals’, more formally known as polyfluoroalkyl substances (PFAS), above certain thresholds in packaging which come into contact with food. The framework also imposes mandatory labelling requirements around packaging to ensure traceability, as well as new requirements to ensure packaging can be collected, sorted and recycled effectively, and expands extended producer responsibility (EPR) obligations, increasing producers' accountability for packaging waste.

Morgan and Hay said the PPWR will affect how life sciences companies package their products and may require them to draw up documentation evidencing compliance. They said some exemptions apply for medical products.

Under the new regime, obligations differ depending on the type of economic operator, with so-called “manufacturers” and “importers” facing more onerous obligations.

Morgan said: “Manufacturers are ultimately responsible for ensuring compliance with the PPWR but they are dependent on suppliers of packaging materials and business partners for data sharing and reporting. Cross-border supply chains introduce further complexity with the PPWR having extraterritorial impact.”

Hay said that because there are a variety of supply chain models in operation within the life sciences sector, including with manufacturing, licensing, co-branding, outsourcing and distribution, life sciences companies should undertake a scoping exercise – if they have not already done so – to identify which economic operator role they fulfil for the purposes of the PPWR so they can understand their regulatory obligations. He said they then should build adequate protections into contractual arrangements to ensure compliance with those obligations.

“This will necessitate a contract repapering process across suppliers and other business partners,” Hay said.

Morgan said that while the initial 12 August 2026 deadline has now passed, many life sciences companies are still working to embed compliance procedures, put in place governance and sign-offs, document new packaging policies, and build databases and other systems to support PPWR documentation. He said life sciences companies can expect this work to come in for scrutiny.

“Enforcement by market surveillance authorities focuses just as much on the ‘compliance framework’ put in place by the company as it does on the compliance of the packaging itself,” Morgan said.

There are some practical steps life science companies can take to ensure their compliance framework for the PPWR is robust, according to Hay.

“Those steps include documenting eligibility and application of exemptions for medical products, monitoring the publication of delegated and implementing acts to keep abreast of phased-in requirements, and establishing suitable regulatory change management processes,” Hay said. “Life sciences companies should also update internal compliance policies as new requirements come into effect and impact existing practices, and ensure relevant staff across packaging, procurement, supply chain, quality, legal and other functions have obtained training on the new obligations.”