EU Packaging & Packaging Waste Regulation: Impact on Healthcare

A new challenge on the heels of the MDR 

When the Medical Device Regulation (MDR) replaced the Medical Device Directive (MDD), it was one of the largest regulatory disruptions the medical device industry had faced in decades. Officially, it’s only four years since implementation in May 2021, but the scale and impact continues to ripple across industry today. The dust is barely settled, and here comes another sweeping overhaul of legislation… this time tackling packaging waste. 

After much discussion, the new Packaging and Packaging Waste Regulation (EU) 2025/40 (PPWR) was finally adopted in late 2024 and will be applicable from August 2026. It aims to reduce packaging waste at every stage, across every industry, for virtually all packaging placed on the EU market. It imposes strict requirements on recyclability, recycled content, and waste reduction. Medical, pharma and diagnostic companies are not fully exempt from this shake up, and many businesses will need to start to rethink their packaging strategies.  

So, just on the back of the MDR and with another major compliance challenge ahead, what does this mean for healthcare packaging, and what do you need to know about the PPWR? While PPWR applies to nearly all packaging, there are targeted exemptions and delayed requirements for healthcare, recognising its unique functions. It’s critical for stakeholders in medical, pharma and diagnostic sectors to understand where they have some leeway, and where they must still comply.  

Recyclability

A central goal of the PPWR is recyclability. There are two key deadlines to understand, first by 2030 all packaging placed into the market must be designed for recycling. Second, by 2035 packaging must be recycled at scale, meaning it’s collected, sorted and processed by real world infrastructure. The staggered timeline reflects the need for new and significant expansion of recycling systems across the EU, capable of handling not only the amount of waste, but also the variety.  

A gap here is the lack of a harmonised definition of designed for recycling means. It is recognised that industry needs to align around a common set of rules. Therefore, Design for Recyclability (DfR) criteria will be developed and is expected to be implemented by 2028.  

The legislation also introduces recyclability performance criteria in Annex II. By 2030 only packaging graded A, B or C i.e. 70% or above recyclable by weight will be allowed. Grades D & E will not be considered recyclable and will be banned. This bar is raised again in the long term, and grade C will be phased out by 2038, meaning only materials above 80% recyclable will be permitted. 

For healthcare packaging, the regulation does have a delay for “contact sensitive packaging” which includes packaging for medical devices, in-vitro diagnostic devices, medicinal products and certain highly sensitive foods (e.g. infant formula and medical foods). It acknowledges that these applications have higher safety and sterility requirements, and thus such packaging is exempt from the 2030 designed for recyclability mandate until a review in 2035.  

In practice this gives healthcare manufacturers extra time to innovate packaging materials, without compromising patient safety. Nonetheless, forward looking companies are already exploring recyclable solutions, anticipating the future.  

Key recyclability takeaways for industry:  

• All packaging placed on the EU market, not including “contact sensitive packaging” will need to be recyclable by 2030 according to Design for Recycling (DfR) criteria.  
• DfR criteria is expected by 2028 
• By 2035, packaging must be recycled at scale (i.e., collected, sorted, and processed in real-world infrastructure). 
• The exemption for contact sensitive packaging will be reviewed by 2035 
  

PCR Content

To promote a circular economy, PPWR sets mandatory minimum percentages of Post Consumer Recyclate (PCR) into any plastic part of packaging. These targets need to also be achieved by 2030 with increasing percentage targets set for 2040. The requirements vary by packaging type, Article 7 and Annex I of the PPWR detail the exact targets and categories. To support this, again, the legislation identifies the need to have a harmonised method to measure recycled content and bring some clarification on a mass balance approach for chemically recycled content.  

Importantly, an exemption is made for healthcare and other sensitive uses. Again, safety and product integrity are prioritised over the use of PCR and the exemption is in place indefinitely for now.  

Key PCR takeaways for industry:   

• Mandatory PCR targets apply from 2030, increasing by 2040
• “Contact Sensitive” plastics have been exempted  

Eco Modulated EPR

Extended Producer Responsibility (EPR) is a financial contribution paid by the company that places the final packaged product on the market. The goal is to use this money to cover the net cost of collection, sorting and recycling of packaging. It applies to all packaging material types such as paper, glass, aluminium as well as plastics. Eco modulated means that fees can be reduced based on recyclability performance. In essence, packaging that is harder to recycle will incur higher fees, whereas packaging that is easily recycled, contains PCR, or is reusable, may benefit from lower fees.  

As of 2025 EU countries must have an eco modulated EPR scheme in place, and by 2030 that fee will also need to correspond to the recyclability grades. It’s important to note a couple of things here. Firstly, the legislation does not give guidance as to how member states should interpret this requirement, therefore individual countries are free to decide how this fee is proportioned, leading to fragmentation. This is being addressed but multinational companies should prepare for potentially complex reporting requirements. 

Secondly, healthcare packaging has no exception here. Fees will need to be paid regardless, and therefore whilst there are delays and exemptions for using either recyclable materials or PCR, there is still a financial incentive to consider these, if possible, to minimise the financial impact.  

It is also worth mentioning that EPR is different to plastic taxes, which as the name suggests is only applicable to plastic packaging and is an additional levy paid to individual countries that have adopted a specific plastic tax, such as the UK.  

Key EPR takeaways for industry:   

• Producers must pay fees based on the packaging they place on the market 
• Contributions will be eco modulated, meaning higher fees for harder to recycle packaging
• Healthcare packaging is not exempt  

Minimisation

There is a strong emphasis on preventing packaging waste at source by eliminating excessive or unnecessary packaging. The legislation therefore introduces a requirement by 2030 to comply with a minimisation measure based on weight and volume. This includes capping the empty space ratio to a maximum of 50% by 2030. Practically, this will force packaging designers to eliminate overly thick material, or redundant layers that do not serve a purpose. This is one area where the healthcare industry already performs relatively well. Packaging is more functional than appealing to a consumer—for example, design tricks such as false bottoms to increase perception of volume are not typical. But there is certainly room for improvement. Industry can look to lighter weight packaging, eliminate dead space, and consider right-sizing packaging. Clearly shrinking packaging not only meets the minimisation requirements but also saves on materials and has a knock-on effect at reducing emissions.  

Key minimisation takeaways for industry:   

• EU countries will have to reduce the volume of packaging waste per capita by 5% by 2030, 10% by 2035, and 15% by 2040 (based on 2018 levels)  
• Maximum 50% empty space ration by 2030 
• Healthcare industry can look to minimise excessive packaging by considering lighter weight materials and optimising pack sizes
  

Reuse

To tackle single use, PPWR introduces reuse and refill targets for certain packaging formats. For healthcare, certain packaging simply cannot be reused for health and safety reasons and again, this is recognised, and so there is not any reuse target set for healthcare packaging. It’s still worth exploring this reuse requirement though in the context of transport and logistics supply chain.  

There is a requirement to substitute any single use shipping boxes and pallets with durable, reusable systems. By 2030, 40% of transport packaging should be reused across the EU when shipping to a customer. While for internal logistics that target is 100%. Some exceptions exist, such as flexibles in contact with food, cardboard boxes, and the transport of dangerous goods. Don’t forget this regulation applies to ALL packaging, so it’s important to review the role of logistics.  

Key reuse takeaways for industry:   

• Reuse and refill targets do not apply for healthcare packaging 
• Companies should still explore this requirement for their transport and logistics portion of their supply chain
• Cardboard packaging is excluded from all reuse targets, so these measures do not apply   

PFAS Restrictions

The regulation bans intentionally added PFAS in food-contact packaging, starting in August of 2026. They are targeted based on the physical properties of PFAS, particularly their persistence, together with the identified effects on health. PFAS represent an environmental and human health hazard, often referred to as “forever chemicals”. To comply, food packaging must not contain PFAS in concentrations exceeding 

• 25ppb for any individual PFAS 

• 250 ppb for the sum of all PFAS 

• 50 ppm for total organic fluorine as an indicator for total PFAS. 

Whilst PFAS is framed around food contact packaging, healthcare companies are also following PFAS free. This is one of the first deadlines under the PPWR to go into effect. Article 5 on substances of concern also maintains the long-standing heavy metal limits and empowers the commission to monitor other substances of concern in packaging going forward.  

Key PFAS takeaways for industry:   

• One of the first deadlines under the PPWR to go into effect 
• Intentionally added PFAS is banned in food contact packaging above starting in August of 2026
• Some healthcare manufacturers are making a switch to non-intentionally added PFAS 

Labeling and Claims

PPWR also introduces harmonised labeling requirements. The aim is to make it easier for people to sort their waste correctly and to crack down on any misleading environmental claims.  

From 2028, all packaging will need a label showing what material it is made of and clearly identifies which parts of the pack can be recycled in which stream. The EU commission is developing a set of standardised pictograms that will appear not only on the packaging, but also on the corresponding waste bin.  

In addition, packaging that contains certain substances of concern will require digital markers, like a watermark or RFID tag by 2030. These markers are intended for waste handlers to help them identify problematic materials and ensure they are handled safely.  

For healthcare packaging, these labeling requirements do apply, however an exemption is allowed if there is limited space due to existing regulatory labeling requirements.  

 Article 12 issues guidelines on packaging labels specific to marketing claims to avoid misleading consumers. This is aimed at curbing vague unsubstantiated claims with the growing concern of greenwashing. Terms like “eco-friendly” will face stricter scrutiny, and there are clear definitions on the meaning of biodegradable and compostable. Any claims will need to be specific, accurate and backed by evidence.  

Key labeling and claims takeaways for industry:   

• From 2028 all packaging must carry harmonised labels, pictograms will be standardised  
• Healthcare packaging is included but limited space can allow an exception 
• Stricter rules on marketing claims that must specify if it relates to the entire pack or only components   

Conclusion  

In summary, the PPWR marks a significant shift in how packaging must be designed, labelled and managed across the EU. For healthcare companies, specifically, where safety and sterility are paramount, it can bring some added challenges. While certain exemptions and extended timelines acknowledge these complexities, the overall direction of travel is clear: more sustainable, circular packaging is the future, even for healthcare.  

Now is the time to prepare. The grace period offered around recyclability and PCR content should be seen as a strategic window to explore new materials, rethink pack formats, and future proof packaging systems. As we learnt with the MDR, companies that act early will be better positioned, not only to meet compliance obligations, but reduce costs and lead the way in sustainable healthcare.   

Check back next week for a quick guide on actionable steps you can take to better prepare.