Challenges
The immediate challenge – ban of next generation propellants
The European Commission revised the F-gas Regulation, which entered into force in March 2024, introducing stricter limits and phase-out timelines for the use of fluorinated gases in the medical sector.[5] This revision sets deadlines for the phase-out of exemptions for the use of HFC-134a and HFC-227ea as propellants in pMDIs. In addition, the revised regulation phases down the use of HFC-152a, one of the next-generation propellants, in line with its global warming potential.
In addition, the European Chemicals Agency (ECHA) is currently evaluating a proposal for a broad restriction of per- and poly-fluoroalkyl substances (PFAS) under the REACH regulation due to the persistent, bioaccumulative, and potentially harmful nature of PFAS compounds.[6] This proposed restriction covers a wide range of uses, including pMDIs. ECHA is taking a precautionary approach by defining PFAS by chemical structure, rather than assessing each substance individually according to its specific properties.
One of the next generation propellants, HFA-152a, is now regulated under the revised F-gas Regulation, while the other, HFO-1234ze, may be subject to the proposed PFAS restriction.[31] However, it is important to note that not all PFAS are the same.[3] HFO-1234ze and HFA-152a offer lower GWPs than HFA-134a, the most commonly used propellant in current pMDIs, specifically, 99.9% and 89% lower, respectively.[3]
Implications of the F-gas and PFAS restrictions
The consequence of the revised F-gas Regulation and PFAS restriction is a potential ban of both next generation propellants. Propellants are essential to deliver inhaled medicines deep into the lung where they exert their therapeutic effect. Without a propellant, there is no way to deliver medicines using pMDIs. Both the F-gas Regulation and PFAS restriction proposal may thus reduce the availability of pMDIs.[31]
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Restrictions on the use of a class of chemicals used as propellants in pMDIs will have a detrimental impact on the health of millions of people around the world who rely on these devices.
Responses so far to restrictions on propellants
To date, ECHA has received thousands of submissions to the public consultation on the PFAS restriction proposal across all areas of consideration, from organizations, companies and individuals.[42] Respiratory experts,[16, 31, 32] respiratory organizations[26] and International Consortia[43] consider that too-rapid an implementation of F-gas Regulation and PFAS restriction, would adversely affect the lives of many people worldwide, and urge authorities and clinicians to consider safety for patients as well as safety for the planet.[26] Collectively, these individuals and organizations have called on national and EU legislators responsible for regulations relevant to inhalers to ensure that:
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medical supplies of current propellants remain available until inhalers with low GWP become available in sufficient quantities for people everywhere;
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sufficient time is allowed for new generation propellants to be developed and prescribed for vulnerable people; and
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the next generation propellants should be excluded from the scope of the F-gas Regulation and the PFAS Restriction proposal as they pose a negligible threat to the environment.
The second public consultation on the PFAS Restriction proposal is expected to be launched in 2026. It is important that we continue to raise awareness on the need for the exclusion of molecules used as pMDI propellants from the F-gas Regulation and the PFAS Restriction proposal – especially those molecules which are both environmentally- and patient-friendly. We encourage everyone to engage in the ECHA consultation process.
PFAS Restriction Timeline
The PFAS restriction proposal was prepared by authorities in Denmark, Germany, the Netherlands, Norway and Sweden and submitted to ECHA on 13 January 2023. It aims to reduce PFAS emissions into the environment and make products and processes safer for people.[44] The six-month consultation ran from 22 March to 25 September 2023.
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A second public consultation is expected to be launched in 2026. During this consultation, ECHA will be actively seeking additional expert opinion on the socio-economic impact of the proposed restriction, including from stakeholders from outside the EU.
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ECHA’s final opinion is expected to be submitted to the European Commission in 2026, after which the Commission will draft a legislative proposal. Member States will then vote on this proposal. If adopted, the PFAS ban could come into effect as early as 2029, following the anticipated transition period.
