Per- and polyfluoroalkyl substances, or PFAS, a broad group of chemicals often referred to as “forever chemicals”, raise serious environmental and health concerns because they can persist in the environment and accumulate over time, impacting human and environmental health. However, some PFAS-related substances are also used in medical products, including pressurised metered-dose inhalers, or pMDIs, where propellent gases help deliver medicines directly into the airways.
These medicines are a necessity for the millions of patients in Europe affected by Asthma and COPD. They help to prevent symptoms, manage flare-ups and keep patients breathing safely. The EU’s latest proposal to restrict PFAS might reduce access to these treatments.
EFA fully recognises the need to address the environmental and health impact of PFAS, but any transition must protect patients who rely on inhaled medicines every day. This is why we responded to the European Chemicals Agency consultation and prepared a position paper setting out the patient perspective on the proposed PFAS restriction.
What is happening at EU level?
On 26 March 2026, the European Chemicals Agency (ECHA) published the Draft Opinion of their Committee for Socio-economic Analysis (SEAC) on the proposed EU-wide PFAS restriction under REACH, the EU regulation on chemicals.
In the Draft Opinion, pMDIs and their associated components (such as coatings) are considered under "Other medical applications”. However, SEAC states that it could not entirely assess such uses in time, classified in the present proposal as PFAS due to their structure. As a result, it could not assess if proposed time unlimited derogations were justified for this sector. Instead, SEAC recommends a time-limited derogation for “other medical applications” until a full assessment is completed.
In addition, the updated F-Gas regulation seeks to completely phase out hydrofluorocarbons (HFC) in the EU by 2050. Two of the three HFCs currently approved by the European Medicines Agency (EMA) - HFA-134a and HFA-227ea will be phased out under the F-Gas Regulation. The third, HFA-152a may also be phased out under the F-Gas regulation, and an upcoming solution, HFO-1234ze may also fall under the REACH proposal, leaving only one HFC option for PFAS based pMDIs.
MDI devices available today contain materials that are categorised as PFAS and fall within the scope of SEAC’s support for an EU-wide restriction subject to derogations. EFA acknowledges the different persistence in the environment across the types on PFAS but urges ECHA to look at the different levels of restrictions as certain propellant gases used for inhalers have not been classified as PFAS in other countries due to non-persistence in the environment.
For EFA, these restrictions raise important concerns. A restriction designed to reduce environmental harm must not unintentionally disrupt access to essential respiratory treatments. Patients with asthma and COPD need a transition that is clinically safe, economically fair and based on real-life patient needs. EFA response to the public consultation supports prevention and a healthier environment for patients and the wider population. At the same time, it calls on ECHA and the European Commission to fully assess the potential impact of generalised PFAS restrictions on respiratory patients.
EFA Community priorities
EFA’s position paper sets out recommendations for ECHA and the European Commission for the revision the REACH proposal. These recommendations are based on input from EFA’s member associations, which represent people living with allergy, asthma and COPD across Europe.
Consider health in the SEAC assessment. SEAC’s assessment lacks sufficient focus on health impacts. pMDIs were not fully assessed, creating risks for asthma and COPD patients. EFA calls for patient evidence and EMA involvement.
Consider the legal basis for REACH and ECHA. EFA supports strong environmental standards, but the assessment must also reflect the role of PFAS-related substances in medical products. The health benefits of pMDIs, and the risks of disrupting access to them, need to be properly considered.
Support the economic transition for patients. The shift to greener medicines should not increase costs or reduce access for patients.
Assist the clinical transition for patients. Treatment changes must be gradual and involve patients and clinicians. The 6-year derogation lacks evidence and may risk patient health.
Global transition for patients across borders. Rapid restrictions could harm access to asthma and COPD treatments globally, especially in low-income countries.
Inform and involve patients. Patients need clear information on treatment, environmental impact, and proper use to support a successful transition.
What comes next?
Now ECHA has collected stakeholder views. SEAC will review them and is expected to adopt its final opinion by the end of 2026. Together with the ECHA’s Committee for Risk Assessment (RAC) final opinion, this will conclude ECHA’s scientific evaluation of the PFAS restriction proposal. The opinions will then be submitted to the European Commission, which will prepare a legislative proposal for discussion and vote by EU Member States in the REACH Committee.
EFA urges ECHA and the European Commission to ensure that the proposed PFAS restriction protects both environmental and patient health. People with asthma and COPD should not face reduced access to treatments they rely on, higher costs or unsafe treatment changes as a result of the transition.
EFA remains ready to engage with ECHA, the European Commission and other stakeholders to help shape a balanced approach: one that supports a healthier environment while protecting the patients who depend on inhaled treatments every day.
Thank you to our members for their impactful contribution to EFA’s response!