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The EU’s PFAS regulation – and what it means for our industry

By July 14, 2023No Comments


It’s claimed that this would be a major climbdown from the EC’s plans to ban up to 12,000 hazardous substances under REACH regulation. Many of these are so-called “forever chemicals” or per- and polyfluoroalkyl substances (PFAS), which can build up in nature and human bodies and can cause a variety of illnesses. The alleged watering down of the regulation is attributed to industry pressure.

How will the new regulation affect IVDs and what would the EU’s potential change of direction mean?

What are the proposed changes to REACH?

PFAS have been approached individually by the EU so far. This has led to risks of “regrettable substitution,” where users move from a banned substance to one that has similar, if not worse effects, not previously identified.


To avoid that, the European Commission has proposed to ban the whole PFAS family of substances, irrespective of any hazard having been confirmed.


The EU’s initiative is part of a global awakening to the hazards of PFAS chemicals, as global action is being taken under the UN Convention on Persistent Organic Pollutants. Implementing this convention is a requirement of OECD membership, meaning that an increasing number of countries are signatories.


What would this mean for our industry?

For the IVD sector the planned extension of REACH poses a number of challenges.


First, while recognising their drawbacks, these substances are often chosen for their specific technical properties or because they make the device more durable. Given the importance of durability as the world moves away from single-use and ‘fast-use’ products to sustainable ones, this raises obvious concerns if alternatives are not available.


Second, many PFAS uses are incidental because they are present in components obtained through the supply chain. PFAS may be used several steps upstream, with little or no visibility to an IVD company buyer.


Third, individual IVD companies have limited influence on the chemicals sector’s search for alternatives. Until such substitutes are identified – and proven to be safe and effective – our sector could face a great dilemma. We could be forced to get rid of substances we have no replacement for in the short to medium term.


Even if specific devices are granted ‘essential use’ exceptions – which is a concept still being developed – we will see upstream PFAS producers increasingly cease production. This is driven not only by regulatory compliance but also by litigation risk and investor, NGO and public pressure. For instance, 3M has already stated that it will cease production of PFAS family substances by 2025.


Finally, a broad ban on PFAS could be a slippery slope toward future bans of other families of chemicals. And if these are only introduced in Europe and not applied to imported goods, the EU market will be left not only with significantly fewer chemicals, but also at a significant commercial disadvantage.


What should the IVD sector do now?

No matter how many or how few substances REACH will ultimately ban, the IVD sector needs to get ready to act, by


  • Auditing usage of PFAS substances within organisations, including both intentional and incidental uses in the upstream supply chain.
  • Avoiding use of PFAS where feasible, especially for newly designed devices and spare parts, and applying detailed supply chain due diligence.
  • Identifying and testing alternatives, working collaboratively, and with the chemicals sector through schemes such as CPI in the UK or IHI in the EU to find common solutions.
  • Working collaboratively with the supply chain to move to suitable alternatives.
  • Preparing to deal with growing activism by the public, NGOs and other interest groups over the continued use of PFAS which continues to gain momentum. Whatever the European Commission ultimately decides, companies must be able to justify any continued use of PFAS.
  • Implementing PFAS emissions prevention and waste control throughout the product lifecycle. In the EU, this will, at least in part, be covered via the SCIP database. Outside the EU, companies may need to explore take-back processes to ensure that affected parts and devices are treated appropriately.

What about the UK?

In the UK, we are seeing a divergence in approaches to chemicals assessments compared to the EU. This could result in differing requirements for the UK market compared to the EU, potentially impacting our supply chains.


The difference in assessing phthalates between the EU and the UK is a case in point. While the HSE concluded that there was little risk in using BPB instead of BPA, the EU is looking to ban more of the Bis-Phenol family to avoid regrettable substitution.



Ignore PFAS at your peril

The change in approach under EU REACH regulation – along with similar policy initiatives in the UK and around the globe – poses a significant risk for the IVD sector. We need to act now rather than wait; PFAS will be banned. It’s just a matter of time and scope.


And, as the adage says, with every risk comes opportunity. While the task ahead may seem overwhelming, it affords us an opportunity to update our ways of working. This will not only benefit our planet and its people but make our industry more resilient and better able to respond to a fast-changing regulation and supply chain.

Natalie Creaney