The EU bans PFASs - and now?

Following the online panel discussion "The EU bans PFASs - and now?”, organized by the regional industry association wvib, the regional newspaper Badische Zeitung threw the spotlight on the possible blanket ban. Katharina Meyer, editor for the section “Science and Medicine”, published her article “Medium-sized Companies Sound the Alarm over PFAS Ban” – a necessary step towards a broad social debate that is currently lacking.

Let us be clear again - we are not opposed to regulation and do not insist on a particular approach. Sutter simply demands a kind of regulation that can withstand a reality check and serves the goal without causing immense damage elsewhere.

As of now, the European Chemicals Agency (ECHA) aims to reduce the discharge of PFAS into the environment to zero by a proposed restriction for almost 10,000 chemical substances. ECHA also defined exemptions from further proceedings for three product groups: pesticides, biocidal products, and pharmaceuticals. All three product groups are largely aimed at protecting health and curing or preventing diseases within our society. These objectives undoubtedly apply to medical devices as well. However, the proposed restriction does not exclude highly regulated medical technology products but lumps them together with consumer goods and other industrial products. 

Our precision instruments for minimally invasive surgery are niche market products, not consumer products like disposable coffee cups, outdoor wear, or Teflon pans. The latter are manufactured in immense quantities and, unlike our medical devices, disposed of in an uncontrolled manner at the end of their life cycle. The substances PTFE, ECTFE and PVDF Sutter uses in our manufacturing processes are persistent, but chemically stable, non-toxic, non-biodegradable, non-water soluble, and non-mobile fluoropolymers. The medical technology sector is one of the areas with the lowest probability for a technical substitution. Why? Because the substances we use need be biocompatible, extremely thermally stable, chemically inert and highly electrically insulating - in other words, persistent.

Unfortunately, we do not share the rather optimistic assessment expressed by Jutta Paulus, MEP Group of the Greens/European Free Alliance, that there might be a rather generous regulation for the medical technology sector. Why was such a generous regulation not in place from the beginning? Our only possibility to act is to send in scientific and technical information on the manufacture, placing on the market and use of PFAS in our products to ECHA by September 25, 2023. Of course, we have done that, in parallel also via SPECTARIS, the German Industry Association for Optics, Photonics, Analytical and Medical Technologies. The outcome is uncertain, long-term planning security as well. The envisaged time limit for exceptions of up to 12 years is equally pointless, not only in view of the lack of alternative substances in our case, but also when it comes to supply chains - a guaranteed availability of PFASs for the granted period is more than questionable.