Not all PFAS are hazardous. They are persistent, to be sure, and we must avoid their emission into the environment. But not all PFAS are bioaccumulative, toxic and mobile; often they are needed as alternatives to chemicals that have been shown to be toxic or unsafe. Society needs long-lived chemicals where their longevity is critical to their translation into technologies and applications.
The European Chemicals Agency (ECHA) is currently consulting on a general ban of PFAS (per- and polyfluoroalkyl substances), a group of high-performance substances used in various industrial applications and consumer products due to their exceptional properties such as heat, water and oil resistance.
The planned EU ban would apply directly to all of the approximately 10,000 PFAS substances, a blanket ban rather than risk-based regulation.
Sutter supports the fundamental goal of keeping hazardous PFAS out of the environment - but regulation must make a compelling distinction between hazardous and non-hazardous PFAS substances, the so-called "polymers of low concern."
The latter, harmless group includes the substances PTFE, ECTFE and PVDF used in construction components of our precision instruments for minimally invasive surgery. All three of these fluoropolymers are chemically stable, non-toxic, non-biodegradable, non-water soluble, and non-mobile materials that have no significant environmental or human health impacts*. In fact, they are so harmless that they are also used in implantable products and are safe.
It is absolutely right and important to strictly regulate the use of low molecular weight PFAS of concern - as has already begun - or to ban them altogether. However, it is equally important to take a differentiated view of this highly complex issue. The Broad Restriction Proposal, however, does not distinguish which PFAS are actually hazardous and which are not.
In our view, it will take the will of politicians and society to allow the use of fluoropolymers and fluoroelastomers without restriction where they bring us all undeniable benefits.
A six-month public consultation, which ends on September 25, 2023, will hardly suffice for this. Neither will leaving the final decision-making to authorities, committees and the Commission alone. The pros and cons must be weighed in public discourse, as appropriate to the scale of the proposed regulation and to liberal democracies.
Only if a differentiated, pragmatic approach is chosen will it be possible to reconcile the various justified interests: those of environmental and health protection, patient protection, innovation and Europe's leading industries.
(*see Barbara J Henry et al. (2018), A Critical Review of the Application of Polymer of Low Concern and Regulatory Criteria to Fluoropolymers; Integrated Environmental Assessment and Management; Volume 14, Issue 3.)