A proposal to ban per- and polyfluoroalkyl substances (PFAS) was published by the European Chemicals Agency (ECHA) in March 2023. After the current running 6-month public consultation, the European Commission will decide on the ban based on ECHA committees’ opinions, which is expected in 2024.
The scope of the ban is very broad (covering more than 10,000 PFAS substances) and the medical and pharmaceutical sectors will be heavily impacted. Fluoropolymers and fluoroelastomers, which are currently included in the proposed restriction, are used in enormous products in medical scenarios due to their outstanding properties and functions. Fluoroelastomers like FFKM are needed for autoclavable sealings in equipment for manufacturing of medicines.
For instance:
- PTFE/PFA is used as a coating for catheters and as material for filters due to its lubricity and chemical inertness;
- PVDF is used as material for cochlea implants due to its piezo, ferro- and pyroelectric characteristics;
- ECTFE is used as a coating for monopolar and bipolar devices in electrosurgery due to its high dielectric strength.
Two restriction options are proposed for different use sectors based on the technical and economic feasibility of alternatives. Most of the use sectors in medical technology are proposed for restriction option 2 with a 12-year derogation after 18 months transition period.
However, we believe this timeline is still too tight. From finding alternative materials to updating production processes, to going through regulatory clearance, we expect a time frame of 20 years or more.
Eventually, PFAS will be disappeared from the medical sector. Companies should respond as early as possible by screening their product portfolio, understanding the applicable restriction, and evaluating business impact first.
