PFAS Chemicals in Medical Devices and the impact of the proposed PFAS restriction
Per- and polyfluoroalkyl substances (PFAS) have recently drawn major concern due to their persistence in the environment and potential health impacts. These synthetic chemicals provide water, grease, and temperature resistance, making them useful coatings and additives in many products, including medical devices. However, regulatory agencies are now proposing strict limitations on certain PFAS due to bioaccumulation and toxicity issues.
The European Chemicals Agency (ECHA) recently published a proposal for the restriction over 10,000 PFAS variants under REACH legislation. As the global regulatory landscape shifts, medical device manufacturers will face pressure to proactively develop PFAS-free solutions.
In this blog, we explore how the proposed PFAS restriction will impact different sectors, what medical devices will be affected in the PFAS ban and how to get started with a PFAS replacement project.
Let's jump right in.
What are PFAS chemicals?
Per- and polyfluoroalkyl substances, more commonly referred to as PFAS substances, make up a group of over 12,000 chemicals, which have been dubbed “forever chemicals”, due to their inability to effectively break down. The widespread use and exposure of PFAS chemicals has led to serious environmental and health impacts around the world. It is estimated that in the EEA countries alone, the health related costs of PFAS exposure amount to €52-84 billion annually. This total relates to a combination of workers at chemical and manufacturing sites, communities located close to chemical plants exposed via drinking water, and the general population who are exposed via consumer products.
Are PFAS Chemicals being banned in Medical Devices?
In an effort to control the use, risks, and impacts of PFASs, a restriction was proposed by the authorities in Denmark, Germany, the Netherlands, Norway, and Sweden, which was subsequently published by the European Chemicals Agency (ECHA).
The restriction proposal presents two options. The first option (RO1) is an outright ban with a transition period of 18 months after the regulation enters into force. The second option (RO2) is presented as the preferred option in the proposal itself, and allows for two different derogation options (5 and 12 years), depending on the PFAS use. While RO2 will delay the benefits that a restriction will bring about, it helps to reduce and control much of the socio economic impact that an outright ban would present.
How will a restriction impact different sectors?
The sectors outlined in the restriction proposal, considered the “major PFAS use” sectors, are as follows:
Will medical devices be affected in the PFAS ban?
The medical device sector is an important consideration in the planned PFAS restrictions. The types of devices referenced in the restriction proposal, and any derogation plans are summarised in the table below:
1* - 12 year derogation proposed, given the strong evidence that economically feasible alternatives will not be available by the date of effectivity, and it is expected to take more than 5 years to identify, develop, and certify those alternatives.
2* - Originally proposed for derogation, but following report consultation, it is found that the evidence that alternatives will be not available by the date of effectivity, is weak. Derogation is therefore under reconsideration, pending provision of substantial evidence.
3* - Expected that alternatives will be available by the date of effectivity, so no derogation is proposed.
What are Regrettable Substitutions?
A regrettable substitution is the term used to describe a situation in which one PFAS chemical is inadvertently substituted with another. Because of the sheer volume of potentially applicable chemicals, it isn’t feasible for a list of restricted substances to be published and therefore, it is the responsibility of each manufacturer/user to analyse the materials used in their products to determine whether or not a substance can be considered to be a PFAS.
Taking into account the OECD definition of PFAS, the restriction will apply to a substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it). In order to avoid regrettable substitution, every applicable substance and any potential replacement must be analysed to determine whether it meets the definition of PFAS.
This is undoubtedly a mammoth task so there is no time to waste in preparing for the seemingly inevitable restriction, regardless of whether a derogation will apply.
How to get started with PFAS
It can be hard to know where to start – some of the key steps in getting your PFAS replacement project off the ground include:
Create a site management plan – even if you benefit from a derogation, it’s expected that this will be in place from the start.
Establish a cross-functional PFAS team within your organisation.
Take a full inventory of all the chemicals that are used by your company.
Start contacting your suppliers to gauge their level of understanding and engagement with the proposed restrictions.
Determine the level of resources that will be required to analyse the chemicals, assess replacement potentials, implement necessary device changes, and assess the impacts on existing global registrations.
If a sufficient level of expertise isn’t already present on the team, start the process of recruiting suitable experts and/or upskilling existing staff.
If your organization faces questions about the proposed PFAS restrictions, accounting for emerging regulations, or implementing proactive phase-outs, our team are here to help. We are ready to partner and leverage our specialized expertise so you can focus on delivering safe, innovative medical devices to improve patient lives.