Asthma + Lung UK                            PFAS0023

Written evidence submitted by Asthma + Lung UK

Understanding the threats and benefits from using

Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)

Asthma + Lung UK is Britain’s leading respiratory health charity and a champion of patients’ voices on lung health. We fight for everyone’s right to breathe.

1. What benefits do PFAS provide and how widely are they used?

PFAS are essential to pressurised metered-dose inhalers (pMDIs), which are prescribed to treat a range of respiratory conditions, including asthma and Chronic Obstructive Pulmonary Disease (COPD).[1] PFAS are not an active pharmaceutical ingredient (API) within pMDIs but they are used as a propellant and as a protective layer within the cannister’s construction.[2] PMDIs account for approximately 86% of the UK’s inhaler usage,[3]  with over 51 million pMDIs prescribed in the UK each year.

At present, pMDIs use either HFC-134a or HFC-227ea.[4] These will be replaced by PFAS with lower Global Warming Potential (GWP), such as HFO-1234ze(E),[5] and non-PFAS alternatives such as HFC-152a[6] in the next generation of inhalers, with the first low-carbon pMDI approved for UK use in May 2025 using HFO-1234ze(E).[7]

2. To what extent are UK health and environmental regulators equipped to detect, monitor and understand the risks posed by PFAS?

PFAS within pMDI inhalers impact patients’ relationships with their medicine. Patients can note changes in their medication, even when the active pharmaceutical ingredients remain the same.[8] Changes in propellant can impact the taste or mouth-feel (sometimes referred to as texture) of the inhaled medicine, and these changes can affect whether a patient finds the medicine acceptable which may impact usage.[9] Where patients don’t take use their inhalers as prescribed, they are at a heightened risk of exacerbation, hospitalisation and death.[10]

UK health and environmental regulators are ill-equipped to understand the impact that amendments to PFAS regulation would have on medicine acceptability in patients. While detailed data on the environmental impacts of inhaler use exists, this often comes from relatively small sample groups such as those associated with regional inhaler recycling pilot schemes.[11] In order to better understand the use of inhalers and to aid any regulation of PFAS, the government should create a national inhaler recycling scheme (NIRS).

A NIRS would reduce improper disposal of inhalers, provide recycling solutions for all kinds of inhalers currently prescribed, and place recycling with propellant gas capture as the primary NHS disposal method for inhalers that contain PFAS. A national scheme operating at the national average recycling rate of 44% would remove over 150,000 tonnes of CO2 annually, equivalent to the emissions of driving for over a billion kilometres.[12] In addition to the environmental benefits, a NIRS would generate detailed data on inhaler use, allowing prescribing and patient care to be amended to reduce waste and improve patient outcomes.[13]

Regulating PFAS use in inhalers without detailed data would risk limiting patient access to their essential medicines. This is unacceptable. We know from detailed scoping work on improving inhaler design that a key barrier to improved detail is international supply chain capacity. By regulating the use of PFAS in inhalers, or by demanding a sped-up transition to new propellants, government would likely create a supply shortage, affecting millions of people in the UK with respiratory conditions.

UK regulators should work with the health sector and pharmaceutical manufacturers to streamline product approvals for lower-carbon inhalers. Regulators must also work with patients and the organisations that represent them to understand their needs in detail, ensuring that all policy and regulation is designed around those it will impact the most.

3. How developed is the UK’s research base on the science of PFAS and the technology required to monitor their current and future impact? 

The UK currently spends £70 million annually on lung research, which amounts to less than 2.5% of the £2.8 billion invested in health research each year.[14] As a result, people living with lung conditions are being left behind, and potential improvements in PFAS use could be delayed. In order to be sufficiently effective, the UK’s research base needs increased funding, with funding for research and development in respiratory health needing to triple to ensure the UK is the best place to do respiratory research and to accelerate the development of new treatments, including lower-carbon treatments. Specific training is available in relevant areas – Bristol University offers Doctoral training in aerosol science, for example – but this is only accessible by a small number of people, all of whom are just at the start of their doctoral training.

4. How sophisticated is current knowledge of how and where PFAS enter the supply chain? 

No answer given.

5. What is the current understanding of how PFAS are made and then used in terms of product ranges, and geographical and socioeconomic distribution? 

Despite the range of PFAS and the variation between them, they are often discussed as a homogenous group. It is common for all PFAS to be seen as equally harmful to the environment, though some have a GWP thousands of times small than others.[15] This poor understanding of PFAS risks harmful blanket regulation, whereas a more nuanced approach would see that the benefits of low-carbon PFAS can outweigh their relatively low environmental impact, as is the case for forthcoming new inhaler propellants.

6. To what extent are the Environment Agency, and other relevant UK bodies and research institutions, resourced to understand the current threat posed by PFAS and to monitor their impact going forward? 

PFAS must be understood in context, with regulation appropriate reflecting their benefits as well as their potential environmental harm. PFAS are a vital part of essential medication used by millions of people in the UK with respiratory conditions.

We recommend that medical propellants currently used in pMDIs – namely HFC-134a and HFC-227ea – be afforded an appropriate derogation from any regulation until at least 2030 to allow adequate time for suitable replacements to become widely adopted.

We recommend that HFO-1234ze(E) be granted a permanent exemption as a medical propellant for pMDIs. HFO-1234ze(E) is an important alternative to HFC-134a and HFC-227ea, and presents a long-term option for the continued viability of pMDIs.

7. What are the current technologies and solutions to treat PFAS pollution, how cost effective and efficient are they and do they create additional risks?

At present, pMDIs use HFC-134a and HFC-227ea. These have GWP values of 1430 and 3220, respectively.[16] The next generation of inhalers will use either HFA-152a or HFO-1234ze(E), which have GWP values of 124 and 7, respectively.[17] HFA-152a is not classed as a PFAS.[18] HFO-1234ze(E)’s emissions are between 200 and 460 times lower than current propellants.

Transition to new inhaler propellants is complex, but is the most effective means of lowering PFAS pollution whilst maintaining patients’ access to essential medicines. The first low-carbon pMDIs using next-generation PFAS propellants are already gaining approval for use.[19] UK regulators should support this safe transition and welcome further innovation that can see similar progress made in other therapy areas or other sectors that rely on PFAS.

8. How well equipped is the UK’s research and development base to improve existing approaches to dealing with PFAS? 

The UK currently spends £70 million annually on lung research, which amounts to less than 2.5% of the £2.8 billion invested in health research each year.[20] As a result, people living with lung conditions are being left behind, and potential improvements in PFAS use could be delayed.  In order to be sufficiently effective, the UK’s research base needs increased funding, with funding for research and development in respiratory health needing to triple to ensure the UK is the best place to do respiratory research and to accelerate the development of new treatments, including lower-carbon treatments. Specific training is available in relevant areas – Bristol University offers Doctoral training in aerosol science, for example – but this is only accessible by a small number of people, all of whom are just at the start of their doctoral training.

9. Is the current regulatory regime for the use and disposal of PFAS, including UK registration, evaluation, authorisation and restriction of chemicals (UK REACH), adequate? If not, how can it be improved?

The current regime for the disposal of PFAS in pMDI inhalers is inadequate. Data gathered by the NHS South Yorkshire ICB in 2022 showed that 84% of inhalers are incorrectly disposed of through domestic waste, meaning the PFAS propellants in these devices are released into the atmosphere as waste is crushed or otherwise processed.[21]

Alternatively, inhalers could be processed as part of a national inhaler recycling scheme. A NIRS would reduce improper disposal of inhalers, provide recycling solutions for all kinds of inhalers currently prescribed, and place recycling with propellant gas capture as the primary NHS disposal method for inhalers that contain PFAS. A national scheme operating at the national average recycling rate of 44% would remove over 150,000 tonnes of CO2 annually, equivalent to the emissions of driving for over a billion kilometres.[22] Similar schemes have operated successfully as regional pilots, with some collecting tens of thousands of inhalers that would otherwise release hundreds of tonnes of PFAS into the atmosphere.[23]

In addition to the environmental benefits, a NIRS would generate detailed data on inhaler use, allowing prescribing and patient care to be amended to reduce waste and improve patient outcomes.[24] A NIRS should be established to reduce the carbon footprint of inhaled therapies and to improve prescribing through the effective use of the anonymised data collected on inhaler use.

10. Is a precautionary approach to PFAS desirable or is an approach that uses regulation to assess their benefits and risks more appropriate?

PFAS have many benefits and are essential to vital medicines used to treat common respiratory conditions. It is essential that they be regulated with an understanding of their benefits and risks.

Appropriate regulation would recognise that advancements in PFAS use mean that lower-carbon chemicals can be used to replace high-carbon options. The next generation of inhalers will use either HFA-152a or HFO-1234ze(E), which have GWP values of 124 and 7, respectively.[25] HFO-1234ze(E)’s emissions are between 200 and 460 times lower than current propellants.[26]

Transition to new inhaler propellants is complex, but is the most effective means of lowering PFAS pollution whilst maintaining patients’ access to essential medicines. The first low-carbon pMDIs using next-generation PFAS propellants are already gaining approval for use.[27] UK regulators should support this safe transition and welcome further innovation that can see similar progress made in other therapy areas or other sectors that rely on PFAS.

With regard to the specific approach taken to regulate PFAS, we recommend that medical propellants currently used in pMDIs – namely HFC-134a and HFC-227ea – be afforded an appropriate derogation from any regulation until at least 2030 to allow adequate time for suitable replacements to become widely adopted. 

We recommend that HFO-1234ze(E) be granted a permanent exemption as a medical propellant for pMDIs. HFO-1234ze(E) is an important alternative to HFC-134a and HFC-227ea, and presents a long-term option for the continued viability of pMDIs.

11. Is there any regulatory divergence across the UK in terms of PFAS? If so, what are the implications, and is there a need for a more joined-up approach?

Regulation of PFAS across the UK varies from sector to sector, but broadly sees the transition to lower-carbon alternatives, much as is being done in pMDI inhalers. Blanket regulation – including blanket bans of PFAS – would be incredibly harmful to the millions of people who rely on pMDI inhalers. A joined up approach, involving input from patients and organisations like Asthma + Lung UK and the Taskforce for Lung Health that represent patients, is vital, ensuring that regulators take a broad view of the role and importance of PFAS.

12. How do other jurisdictions around the world, including the EU and US, regulate PFAS use and disposal, and what lessons, if any, can the UK learn? 

Following the approval of the world’s first low-carbon pMDI by the MHRA in May 2025, the UK leads the way on PFAS use in pMDI inhalers. Asthma + Lung UK submitted evidence to ECHA in 2023, highlighting the importance of PFAS to the millions of people that rely on pMDI inhalers to treat their respiratory conditions.

Disposal of inhalers is an international challenge, with mixed success globally; inhaler recycling schemes in other markets, such as the USA,[28] have followed the UK’s pattern of short-lived but promising pilot schemes. It is crucial that the UK learn from its own lessons in this regard and capitalises on the work of pilot schemes with a national inhaler recycling scheme (NIRS). A NIRS would reduce improper disposal of inhalers, provide recycling solutions for all kinds of inhalers currently prescribed, and place recycling with propellant gas capture as the primary NHS disposal method for inhalers that contain PFAS. A national scheme operating at the national average recycling rate of 44% would remove over 150,000 tonnes of CO2 annually, equivalent to the emissions of driving for over a billion kilometres.[29] Similar schemes have operated successfully as regional pilots, with some collecting tens of thousands of inhalers that would otherwise release hundreds of tonnes of PFAS into the atmosphere.[30]

In addition to the environmental benefits, a NIRS would generate detailed data on inhaler use, allowing prescribing and patient care to be amended to reduce waste and improve patient outcomes.[31] A NIRS should be established to reduce the carbon footprint of inhaled therapies and to improve prescribing through the effective use of the anonymised data collected on inhaler use.

13. What lessons can the UK learn from other countries in terms of resourcing and supporting the detection, monitoring and treatment of PFAS pollution?

PFAS pollution caused by pMDI inhalers must be tackled both through innovation in product design, with lower-carbon alternatives holding great promise in the near future, and through innovation in disposal, namely through a national inhaler recycling scheme that integrates gas capture to prevent waste PFAS propellant from entering the atmosphere.

Disposal of inhalers is an international challenge, with mixed success globally; inhaler recycling schemes in other markets, such as the USA,[32] have followed the UK’s pattern of short-lived but promising pilot schemes. It is crucial that the UK learn from its own lessons in this regard and capitalises on the work of pilot schemes with a national inhaler recycling scheme (NIRS). A NIRS would reduce improper disposal of inhalers, provide recycling solutions for all kinds of inhalers currently prescribed, and place recycling with propellant gas capture as the primary NHS disposal method for inhalers that contain PFAS. A national scheme operating at the national average recycling rate of 44% would remove over 150,000 tonnes of CO2 annually, equivalent to the emissions of driving for over a billion kilometres.[33] Similar schemes have operated successfully as regional pilots, with some collecting tens of thousands of inhalers that would otherwise release hundreds of tonnes of PFAS into the atmosphere.[34]

In addition to the environmental benefits, a NIRS would generate detailed data on inhaler use, allowing prescribing and patient care to be amended to reduce waste and improve patient outcomes.[35] A NIRS should be established to reduce the carbon footprint of inhaled therapies and to improve prescribing through the effective use of the anonymised data collected on inhaler use.

14. How does the UK compare to other countries in terms of funding research and new technologies to improve outcomes? 

The UK is the first market to approve and license a low-carbon pMDI inhaler, but further investment in research and innovation is needed to broaden the number of products using lower-carbon propellants and to expedite the UK’s transition away from high-carbon PFAS. 

The UK currently spends £70 million annually on lung research, which amounts to less than 2.5% of the £2.8 billion invested in health research each year.[36] As a result, people living with lung conditions are being left behind, and potential improvements in PFAS use could be delayed.

Investing in lung health research would reap considerable rewards for the UK economy. Research by Asthma + Lung UK and PwC found that increasing investment in respiratory research to a total of £721 million over a seven-year period would contribute £851 million to the economy by 2030,[37] and lead to an additional £699 million in wider private sector investments.[38]

May 2025