Packaging, PFAS, carbon footprint: How can healthcare industries prepare for upcoming regulatory deadlines?

Packaging and waste: The PPWR does not eliminate healthcare sector specificities but regulates them more strictly

The PPWR does not provide for a general exemption for packaging and waste in the healthcare industries. Instead, it adopts a more targeted approach. The general legal framework remains applicable, subject to certain exceptions justified by the specificities of the sector. The European Commission thus specifies that the harmonized sorting labelling obligations provided for in Article 12(1) of the PPWR do not apply to certain packaging. This notably includes packaging for human or veterinary medicinal products, medical devices and in vitro diagnostic medical devices when intended for professional users, such as hospitals, clinics, hospital pharmacies, medical biology laboratories or healthcare professionals.

The Regulation also provides that this article does not apply to the primary packaging or outer packaging of human or veterinary medicinal products, medical devices and in vitro diagnostic medical devices where there is insufficient space on the packaging due to other labelling requirements imposed under EU law, or where adding such marking could compromise the safe use of the product. At this stage, the Commission has indicated that, for medical devices and in vitro diagnostic medical devices, this exception notably covers packaging in direct contact with the product as well as outer packaging. However, its practical application will still need to be clarified and assessed on a case-by-case basis, taking into account sector-specific labelling constraints and product safety requirements.

The Commission also recalls that certain products, such as infusion bags or pre-filled syringes, may not even fall within the definition of “packaging”. They are not designed as mere containers, but rather as integrated administration devices enabling the safe, sterile and precise administration of the product to the patient. When pre-filled, they form a functional part of the medicinal product or medical device itself and therefore do not constitute packaging intended to be removed in order to access the contents.

Between AGEC and PPWR: Securing the packaging transition

For healthcare industries, the challenge is not only to manage the interaction between the existing national framework and the future harmonized European framework, but also to deal with a transitional phase whose contours remain, at this stage, partially uncertain. In the short term, the obligations arising from the French AGEC Law remain fully applicable in France, particularly with regard to sorting information, extended producer responsibility schemes and the organization of certain specific streams. Operators placing medicinal products or medical devices on the French market must therefore continue to take into account, where required, compliance with the requirements relating to the Triman logo and sorting information.

At the same time, however, Article 12 of the PPWR harmonizes certain mandatory markings affixed to packaging at European level, particularly those relating to sorting. Ultimately, Member States will therefore no longer be able to maintain parallel mandatory national requirements within the same scope. At this stage, however, it remains difficult to anticipate precisely how the current French requirements (particularly regarding logos or markings affixed to healthcare products) will interact in practice with the future harmonized European framework until the relevant implementing texts have been adopted.

In this context, the priority for pharmaceutical companies and medical device manufacturers is probably not to immediately redesign all of their packaging, but rather to secure current French compliance, map the relevant packaging and markings, identify the products most likely to be affected by the new PPWR requirements and closely monitor European implementing acts and national adjustments. Such vigilance is all the more necessary as changes to labelling may also impact regulatory dossiers.

The ban on the use of PFAS: An issue that the healthcare industry should monitor very closely

The PFAS issue should be monitored very closely by healthcare industries. PFAS (per- and polyfluoroalkyl substances) are a broad family of fluorinated chemical substances often referred to as “forever chemicals” due to their extreme persistence in the environment. It is precisely this persistence, together with the scale of contamination observed in soil and water, that led five national authorities (Germany, Denmark, the Netherlands, Norway and Sweden) to submit to the European Chemicals Agency (ECHA), in January 2023, a proposal for a broad restriction on their use under the REACH Regulation.

This initiative forms part of the broader European Union strategy aimed at progressively phasing out PFAS, except where their use may be considered essential. France is also pursuing the same objective at national level through the law of 27 February 2025 on PFAS, which progressively bans certain products containing these substances, without generally covering healthcare products at this stage.

At European level, from a procedural standpoint, the matter has reached a new stage: the scientific committees of ECHA have now adopted their opinion and draft opinion, and the procedure has entered a consultation phase on the draft opinion. Following this consultation, and once a final opinion has been adopted, the European Commission may prepare a proposal to amend Annex XVII of the REACH Regulation in order to prohibit their use.

For healthcare industries, the stakes are significant. In the absence of sufficiently clear and durable derogations, the restriction could affect not only certain medicinal products, but also active substances, manufacturing processes, certain administration devices and certain packaging components.

This is also the position expressed by EFPIA on 26 March 2026: the association considers that the opinions published to date do not support derogations adapted to pharmaceutical uses, despite the fact that the use of PFAS in this sector remains essential. EFPIA notably argues that not all PFAS present the same level of risk for human health or the environment and that any restriction under the REACH Regulation should be based on a sufficiently in-depth and evidence-based assessment of hazards, risks and socio-economic impacts. It also emphasizes that the derogations currently envisaged would not provide sufficient time to identify suitable alternatives, develop waste treatment technologies and appropriate analytical methods, or adapt supply chains.

Substitution is particularly complex in the pharmaceutical sector because, in many cases, no alternative is currently available. Moreover, even where an alternative exists, it must still demonstrate better environmental performance without compromising patient safety, and then undergo industrial and regulatory implementation that may take time. In this regard, EFPIA states that at least 139 active substances, covering 44 therapeutic classes, could be affected, with potential impacts on more than 650 medicinal products included on the WHO essential medicines list and on more than 47,000 marketing authorizations worldwide. According to this analysis, an insufficiently tailored restriction could therefore jeopardize both patient access to treatment and the maintenance of manufacturing capacities in Europe.

In this context, even though the final text has not yet been adopted, the most exposed companies can already anticipate by mapping their PFAS uses, identifying critical dependencies, assessing genuinely available alternatives and evaluating the consequences that substitution would have on their processes and regulatory dossiers.

The carbon footprint of medicinal products is progressively becoming a criterion for public hospital purchasers

The information note of 29 October 2025 published by the French government forms part of the ecological planning of the healthcare system and supports the deployment of a public methodology for assessing the carbon footprint of medicinal products, developed by the ministries in charge of health and the economy. The objective is to enable pharmaceutical operators to calculate, in a standardized manner, the carbon footprint of their medicinal products over their entire lifecycle, in order to provide hospital purchasers with a tool that can be used in procurement procedures.

The note therefore encourages healthcare and medico-social establishments with hospital pharmacies, as well as centralized purchasing organizations, to integrate the medicinal product carbon score into the evaluation criteria for tenders. This criterion may be used as the main environmental criterion, for example, with a weighting set at 10%, while also being supplemented by other environmental or social criteria related to the subject matter of the contract. The methodology must then be explained in the procurement documents, in particular in the technical specifications, or made accessible via a link appearing on the purchaser profile.

The note further specifies that, where this methodology is expressly retained in the procurement documents, the submission by an economic operator of another calculation method could be regarded as rendering the tender irregular. Implementation is intended to be gradual, beginning in the first quarter of 2026 with an initial list of 18 molecules, which is expected to be updated. The use of this methodology remains voluntary at this stage, but it foreshadows a broader development. As from 21 August 2026, the French Public Procurement Code will require that at least one award criterion take into account the environmental characteristics of the tender.

The medicinal product carbon score therefore appears as an operational tool designed to facilitate, within the hospital sector, the implementation of this general requirement. For healthcare industries, this development changes the role of environmental performance in their responses to public tenders. The environmental performance of the product is no longer limited to ESG communication, but is now becoming part of public procurement competitiveness, with potential effects on tender responses, data availability, methodological robustness and, ultimately, comparability between tenders.

In practice, this development requires stronger coordination between tender, market access, industrial, ESG, supply chain and pharmaceutical affairs teams in order to ensure the reliability of the data used, the consistency of the selected methodology and the alignment between the environmental commitments highlighted and the contractual documents submitted to purchasers.

Next steps

Healthcare industries are therefore not exempt from new environmental standards; they must now operate within an increasingly dense regulatory framework. The difficulty is that, at the same time, the European Union is pursuing a complementary but seemingly opposite ambition: strengthening the attractiveness of the continent, reducing critical dependencies, relocating certain manufacturing capacities and consolidating its healthcare sovereignty.

The issue is therefore no longer merely one of compliance but rather one of balancing two equally structuring public policy imperatives: environmental sustainability and security of supply. For companies in the sector, this requires moving beyond siloed reasoning based on individual regulations or functions in favor of integrated governance involving legal, regulatory, quality, packaging, procurement, industrial, market access and supply chain teams. The objective is to document sufficiently early technical limits, transition costs, product constraints and impacts on regulatory dossiers so that environmental objectives do not, in practice, result in a weakening of European healthcare product manufacturing.

Authored by Mikael Salmela and Chloé Cornet.