31.10.2023

The intended European Union ban on per- and polyfluoroalkyl substances (PFAS) is causing discussion throughout Europe. Many companies in the medical technology sector fear that they will no longer be able to reliably manufacture products as before. We talked to expert Dr. Martin Leonhard, who chairs the medical technology section of the German industry association SPECTARIS, about the current situation and what the industry would like to see.

Picture: a man with glasses in a gray suit; Copyright: SPECTARIS

Dr. Martin Leonhard

Dr. Leonhard, the intended PFAS ban is heavily debated. Comments to the responsible European Chemicals Agency ECHA could be submitted through September 25. Do you think this has been used sufficiently by the companies concerned?

Dr. Martin Leonhard: 3,865 companies and associations participated, but small and medium-sized companies, in particular, are clearly underrepresented. In a survey, SPECTARIS, together with the VDMA (Verband Deutscher Maschinen- und Anlagenbauer e. V. - German Engineering Federation) determined that in both associations around 54 percent of member companies participated in the consultation. This shows that the companies are very concerned.

However, the survey also shows that many were simply overwhelmed by the question: either in terms of content or with regard to their resources. SMEs in particular often create niche applications and products that cannot be served by other companies. We, therefore, strongly assume – and have also said this repeatedly in political communication – that not all companies will be able to submit data for measures at the end of the consultation. Nevertheless, we assume that virtually every company will be affected by the comprehensive ban as it is now planned, either directly with its products or at least indirectly through the supply chain and production processes.

What information was required from the individual companies?

Leonhard: Evidence documents had to be submitted – including statements on substitution possibilities. A major focus was placed on PFAS emissions with regard to the product life cycle. Obtaining such emission values outside of one's own value-added cycle is a major challenge within the short phase of the consultation. Just listing which products contain PFAS and would therefore no longer be manufacturable was not enough. Many companies often think they don't have products that would be affected. However, the companies do not even realize that processes and services are also affected. This can be well illustrated by companies that use optical components. Optical glasses do not contain PFAS, but they are usually coated. The coating is done in a high vacuum, and there they need materials that do not outgas. And this does not work without PFAS, for example in the form of VITON® seals.

Image: a young male businessman sits at a desk in the office looking at his screen in confusion, Copyright: envato/ voronaman111

Many companies did not participate in the submissions to ECHA because they felt the questions were too extensive, could not answer all of them, or simply could not assign staff to do so.

But this is not a culpable omission on the part of the companies. The situation is highly complex. There is simply no conclusive list of PFAS substances; there are said to be around 10,000 different substances. There is also no declaration obligation, so that the supplier cannot say for sure whether the product contains PFAS substances. Most of the PFAS substances used in industry do not pose a risk to humans or the environment. The materials are inert, which means they do not react with the environment.

Further articles on this topic from the COMPAMED-tradefair.com editorial team:

At MEDICA, SPECTARIS is exhibiting together with MedicalMountains. In your position papers, you both present similar arguments against a full ban; you see medicine or medical technology as being set back decades without PFAS. Can you give an example?

Leonhard: There are many. Imagine a hospital without anesthesia or ventilation equipment. Imaging procedures as essential pillars of diagnostics will disappear, such as MRI, CT, ultrasound or digital X-ray. Minimally invasive surgery will also cease to exist, and there will be no modern endoscopes without fluoropolymers. Approximately 60 million treatments are performed in hospitals each year. 29 million of them guaranteed with PFAS-dependent devices. It should give us food for thought that half of all hospital treatments can no longer be performed without PFAS. We are talking about high-tech products that save lives, which cannot be dispensed with as easily as a Teflon-coated frying pan. Catheters and stents for heart patients and many other products would also be affected by a far-reaching ban. Laboratories will also have problems, for example in determining tumor markers, and will not be able to continue their work as before.

The list seems endless to me, which is very scary. Which applications would you like to see exempted from the ban?

Leonhard: Currently there is a list that names about fifty possible exemptions. These exemptions are neither certain to be exempt, nor will they be sufficient. Medical technology in general the commission does not want to exempt and then we end up with thousands of exemptions. Then you need a definition for each exception: What is a catheter? Historically, a catheter was something different from what we understand it to be today. There will naturally be ambiguities and details and niche applications will be forgotten. Fundamentally, we would like to see a different approach.

Instead of excluding the entire PFAS substance class, we would have to proceed on a risk basis. After all, in addition to the known hazardous substances, all PFAS substances that have been proven to be non-hazardous will also be banned. We at SPECTARIS are particularly disturbed by the fact that the framework chemicals regulation REACH provides for a risk-based approach, but this has not been implemented with the present proposal. This is also the view of the German government, which is now also calling for a risk-based approach at the conclusion of the chemical summit in September 2023.

Image: a man holds up a lens with his left hand and looks at it; Copyright: envato/svitlanah

Many everyday aids, such as eyeglasses resp. their lenses, would be affected by an all-encompassing PFAS ban.

Do you think the German government will be successful with this?

Leonhard: They have to be. Otherwise we will be thrown back into the middle of the last century! This applies not only to patients, but to everyone. Because economically it will be felt massively. It is dramatic for Europe as a business location and for its industry. Because many supply chains will not function without PFAS. If it is banned in Europe, but remains allowed in non-EU countries such as the USA or UK, then companies will locate there.

SPECTARIS is calling for fluoropolymers to be exempted. What distinguishes them from the other chemicals in the PFAS family?

Leonhard: Safe fluoropolymers have been proven not to pose a risk to humans or the environment. Not only are they inert, they are also insoluble in water, unlike soap-like PFASs, which dissolve readily in water, are bioaccumulative, and can be detected at many sites in water or blood. One known critical representative is PerfluorOctaneSulfone Acid (PFOS). Until it was banned, PFOS was found in firefighting foams or in textile waterproofing sprays.

Nevertheless, fluoropolymers are also to be banned according to the ECHA proposal. However, they play a key role in industry in general and in medical technology in particular. If they were no longer allowed to be used, not only would the healthcare industry have a problem, but also the so-called green technologies could not be further developed, such as lithium batteries, infrastructure for hydrogen technology, heat pumps or roofs with photovoltaic modules.

Nothing has been finally decided yet, but what is your advice to the members of the association? Stay calm and wait, or start looking for alternatives now?

Leonhard: I think it's important to speak out on the issue! The consultation phase is over, but the political process is ongoing. What we don't need is a three-year hanging game. After all, every internationally positioned company will review its investment decisions under the given framework conditions. When comparing the U.S., the EU and Asia, the EU runs the risk of being put at the bottom of a wish list. And that is fatal for our location.

Will you use MEDICA or COMPAMED to talk about further approaches?

Leonhard: Of course. In the MEDICA TECH FORUM, we will also contribute to the topic of PFAS ban with a panel discussion, on November 14th from 15:15 to 17:00. We would like to discuss the pros and cons. Suppliers represented at COMPAMED will certainly also have many questions and ideas on the topic.