Focus on PFAS
Not all PFAS are dangerous; they are persistent, and we must prevent their release into the environment. However, not all PFAS are bioaccumulative, toxic, and mobile. They are often needed as alternatives to chemicals that have proven to be toxic or unsafe. Society needs long-lasting chemicals where their longevity is crucial for implementation in technologies and applications.
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- Category: Inside Sutter | What's happening here
PFAS regulation: differentiation instead of blanket ban
The European Chemicals Agency (ECHA) is currently consulting on a general ban on PFAS (per- and polyfluoroalkyl substances), a group of high-performance substances that are used in various industrial applications and consumer goods due to their exceptional properties, such as heat, water, and oil resistance.
The planned EU ban would apply directly to all approximately 10,000 PFAS substances, i.e., a blanket ban instead of risk-based regulation.
Sutter supports the fundamental goal of preventing hazardous PFAS from entering the environment – however, regulation must distinguish between hazardous and non-hazardous PFAS substances, known as “polymers of low concern.”
The latter, harmless group includes the substances PTFE, ECTFE, and PVDF used in the construction components of our precision instruments for minimally invasive surgery. All three of these fluoropolymers are chemically stable, non-toxic, non-bioavailable, non-water-soluble, and non-mobile materials that have no significant impact on the environment or human health*.
They are so harmless that they are even used in implantable products and are safe.
It is absolutely right and important to strictly regulate or completely ban the use of questionable low-molecular PFAS, as has already begun. However, it is equally important to take a differentiated view of this highly complex issue. The “Broad Restriction Proposal” does not distinguish between which PFAS are actually dangerous and which are not.
A six-month public consultation, which ends on September 25, 2023, will hardly be sufficient for this. Nor will it be sufficient to leave the final decision solely to authorities, committees, and the Commission. The pros and cons must be weighed in public discourse, as is appropriate for the scope of the planned regulation and for liberal democracies.
Only by taking a nuanced, pragmatic approach will it be possible to reconcile the various legitimate interests at stake: environmental and health protection, patient safety, innovation, and Europe's leading industries.
(*cf. 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)