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Source: European Chemicals Agency (ECHA)

This week EFA participated in the European Chemicals Agency (ECHA) consultation on the proposal for the restriction of certain per- and polyfluoroalkyl substances (PFASs). The restriction proposal is grounded on concerns over the persistence of PFASs after being used and released, and the subsequent risks for public health and the environment itself. The restriction proposal has been brought up by several Member States, under the EU chemicals framework legislation (REACH)

The restriction proposal looks at restricting a category of PFAS, hydrofluorocarbons gases (HFCs), which are key elements in metered dosed inhalers (MDIs) to treat chronic respiratory diseases asthma and COPD. The PFAS gas acts as a propellant to push and drive the medicine into the airways, without effort for the patient

Apart from medicines, PFAS constitute a broad range of chemical substances that are used today in many sectors and applications, including in textiles, food packaging, lubricants, electronics and construction.

If adopted, the restriction would address all aspects of PFAS life-cycle, including their manufacturing, placing on the market and use.

EFA considerations on the restriction proposal: Think of patient options! 

EFA’s response to the consultation calls for more scientifically valid information and foresight on how the restriction would affect medication for asthma and COPD and patients. 

Today, MDIs are very commonly used worldwide, constituting 76% of all inhalers used in Europe, and 78% of those used globally. They are considered critical medicines to treat the obstruction of the airways.

Since its foundation, EFA has consistently called for healthier environments and a health-in-all-policies approach. The reduction of harmful exposure to environmental pollution is central to our advocacy work, as it is widely acknowledged as a key determinant for allergy and respiratory health. 

However, the restriction of PFASs from medical applications such as MDIs can lead to various unintended consequences for asthma and COPD patients. Therefore, there must be due consideration to: 

  • the economic cost of research and development is not carried by patients
  • patients are duly consulted on clinical aspects of the different inhaler options, and supported to use them correctly through patient education 
  • the implementation of these restrictions does not pose a barrier in the access to healthcare and basic treatments, especially in third countries
  • people with asthma and COPD are duly informed about their treatment, including its composition, environmental footprint, its presentation and disposal options

EFA calls EU regulatory agencies like ECHA to use this draft restriction proposal as an opportunity to look at the bigger picture around inhaler use in Europe, and further address the health needs, way beyond the environmental needs, to reduce PFAS-based MDI use in Europe.

You can access the full EFA response here. More information on the consultation is available at ECHA’s website.

EFA has also been informing the European Commission on the restriction of use of the same PFAS propellants in asthma and COPD inhalers, which are also labelled as F-Gases under the current revision of the EU 2014 F-Gas Regulation.