Why PFAS is not an exotic topic in chemicals legislation, why it concerns us all and why a blanket ban could shake the foundations of our society, our standard of living and our prosperity.
Fluoropolymers, a small but important subgroup of PFAS, are used in a large number of professional processes and products: No commercial airplane, modern lithium or fuel cell can function without them, nor can any high-performance optical system. Consumer applications such as glasses, cell phones, computers and cars would also not exist in their current form. Their longevity and durability - legislators refer to them as persistence - are the political downfall of these high-performance materials, although this is precisely why they are used. It should be noted that the basis for the restriction is not necessarily a health hazard.
Other PFAS subgroups are also essential, for example in pharmaceuticals, whose effect is based on functional PFAS side groups, or in semiconductor production, where PFAS ranging from inert to highly reactive are usually without alternative. Non-polymeric PFAS also play a central role in this.
Model of the chemical structure of polytetrafluoroethylene (PTFE). Due to its properties, it is used for implants or vascular prostheses, for example
PFAS ban: modern medical care would collapse
At least every second hospital treatment would not take place without PFAS. We are talking about 30 million hospital treatments per year in Germany. Medical devices such as incubators for newborns, heart-lung machines or dialysis machines could no longer be used, just like endoscopy and minimally invasive surgery as important areas of diagnostic and interventional medicine. It was only with fluoropolymers that this medical field became as successful as it is today. Gall bladder, appendix, hernia, uterus, urinary bladder or prostate could no longer be treated gently using minimally invasive techniques; without anesthesia equipment, they could not even be operated on using open surgery. Over a hundred thousand medical devices would disappear from the market, most of them would no longer be available in the EU after an 18-month transition period, and not even the servicing or repair of existing devices in hospitals would be permitted. Longer transitional periods for medical devices are currently only provided for implants, tubes or catheters. But what use are more years if there are no alternative materials in the foreseeable future? Fluorine has the strongest electronegativity of all chemical elements. This is what makes fluoropolymers so special. Politicians should not presume to outwit nature. In the end, the EU is threatened with a relapse into the last century, and not just in terms of medical care.
Fig. 1: Resectoscope for minimally invasive treatment of the prostate, bladder or uterus. Fluoropolymers are used to ensure 5 different functionalities in this product alone
Risk-based instead of a bureaucratic tsunami
The current approach with far-reaching bans and limited exceptions is not practicable, the lawyer calls it a 'ban with reservation of permission'. It will result in a bureaucratic tsunami, because we will have to understand on a daily basis what further exceptions to application would have to be created. The future is open and cannot be predicted by the omnipotent legislator. And no: bans are not drivers of innovation - bans force development departments to implement known solutions 'differently and worse' as a rule. Why? Because "different and better" is automatically invented through competition. They also shackle development departments because no future-oriented innovation happens at that time, at least not in Europe. In the case of medical devices, as in other highly regulated sectors, this means time-consuming and costly recertification of thousands of products.
If you only privilege certain applications, you forget about complex supply chains and prevent innovation. Our supply chain would not be protected by an application-based exemption for medical devices. Supply chains, especially for niche products, will collapse in many places and thousands of niche products, for example for children, would disappear from the market unchecked.
We are therefore calling for an immediate reassessment, not least to prevent further deindustrialization. Risk-based regulation means looking at where there are 'unacceptable risks', as provided for in REACH (Art. 68). Fluoropolymers do not belong in the scope. Emissions during production and at the end of life can be regulated differently and environmental pollution can be avoided, e.g. in consumer applications whose emissions into the environment cannot be avoided, such as ski waxes, cosmetics or certain food packaging. In legal terms, this would be a 'permit with reservation of prohibition'. As a society, we deserve forward-looking policies and targeted legislation. We are firmly convinced that these can be realized in harmony with the goals of sustainability. For the benefit of people and nature.
A wake-up call for us Europeans
Overall, the EU will fall behind internationally as a production location, as machines and systems that are designed for a long service life often require seals and lubricants made from PFAS substances. Do we know whether transitional periods will apply to our production machines in the future? Do we know whether alternatives will be available at the end of transition periods? What security does this provide for investment decisions in Europe?
'Make America Healthy Again' suggests that emissions will also become more of a focus in the USA. This is the right way forward; blanket bans, as envisaged here, are not. More favorable corporate taxes in the USA will boost the US economy, as will courageous steps to reduce excessive regulation. America is providing incentives for industry. This is also a wake-up call for Europe.
The new German government could set an example and withdraw its proposal to the ECHA in order to be able to present a more risk-based proposal. The newly formed EU Commission also offers a unique opportunity to send strong political signals and pull factors for our industry. We now need an 'Industrial Deal' for the coming legislative period. The Commission is putting such a 'Clean Industrial Deal' over the legislation that has just begun, with the promise of putting competitiveness and growth back at the center. That is a good thing and we want to actively support it.
Nevertheless, we are not yet on the right track when it comes to PFAS. Let's take this wake-up call seriously and incorporate it into our day-to-day business, as well as explaining to those around us what prosperity and the standard of living we have achieved are based on. Let us remain vigilant and committed. By the way, the official German translation of the 'Clean Industrial Deal' is: 'Clean Deal for Industry'. To me, the German translation sounds like detention, not like a positive impulse for society.
