ECHA announces support for qualified restrictions on PFAS ‘forever chemicals’

The European Chemicals Agency (ECHA) has taken a significant step toward stricter EU-wide controls on per- and polyfluoroalkyl substances (PFAS), often referred to as ‘forever chemicals’.

Two scientific committees are backing a broad restriction while allowing for targeted exemptions. The move reflects growing concern over the long-term risks these “forever chemicals” pose to human health and the environment.

The Risk Assessment Committee (RAC) took a harder line than the Socio-Economic Analysis Committee (SEAC), concerned by the link to serious health conditions, including cancer and reproductive harm.

"The final RAC opinion and scientific evidence is clear that PFAS can cause risks to people and the environment if not properly controlled,” said Chairman of RAC, Roberto Scazzola. “An EU-wide restriction is, therefore, an effective measure to reduce these risks. If derogations are allowed, RAC recommends measures to minimise PFAS emissions."

RAC emphasised that existing regulations are insufficient and called for stronger EU-wide measures. It also recommended that, if any exemptions are granted, they include emission monitoring, supply-chain communication, consumer labelling, and mandatory reporting of PFAS releases from industrial sites.

Meanwhile, the Socio-Economic Analysis Committee (SEAC) supported the overall restriction in its draft opinion, but it stressed the importance of proportionality. The committee were concerned that, as PFAS are widely used across industries, making a blanket ban potentially disruptive.

“The SEAC draft opinion supports a broad restriction on PFAS, while recognising the need for targeted derogations to keep the measure proportionate and workable,” said Chairperson of SEAC, María Ottati. “This balanced approach will reduce PFAS emissions while allowing certain uses to continue where an immediate ban would, on balance, lead to more negative than positive impacts.”

Medical devices

PFAS often play a crucial role in ensuring the safety and performance of medical devices. They provide effective lubrication for devices such as heart stents and minimally invasive surgical delivery systems, enabling smoother operation within the body. They also act as electrical insulators, protecting sensitive components like pacemaker wires. In addition, their biostability allows devices to remain in the body for extended periods without degrading, which could lead to potentially life-threatening complications.

In May 2024, ahead of European Elections, Commission President Ursula von der Leyen wrote to MEPs in the EPP group, assuring them that she supported a permanent exemption for medicines and products used to reach climate neutrality. This appears to have been secured in the SEAC opinion.

The publication of SEAC’s draft opinion triggers a 60-day public consultation, open until 25 May 2026. Stakeholders are invited to submit evidence-based feedback to help refine the final recommendation. ECHA will then draw up an opinion that will be submitted to the European Commission, which is expected before the end of the year. This will - probably - result in proposed changes or updates to legislation. While most will be targeted at the REACH regulation, any changes concerning medicines will be aimed at the relevant legislation.

The initial proposal for change was proposed by five states (Sweden, the Netherlands, Germany, Norway and Denmark) in 2023. Asked why it has taken so long ECHA told Vital Signs that unlike other requests, PFAS covers 10,000 chemicals used in 23 different sectors, its complex range of uses and impact has meant that the discussions have been long and drawn out.

“The European Commission welcomes that ECHA is advancing its work and looks forward to the ECHA opinions later this year,” said European Commissioner for Environment, Water Resilience and a Competitive Circular Economy Jessika Roswall. “We support the transition away from forever chemicals. As always, any new rules need to be simple by design and give certainty, clarity and predictability for consumers as well as businesses. We also need to ensure a Single Market approach to avoid national fragmentation.”

Dismay from pharma

“The opinions expressed today by the ECHA are alarming given what's at stake for patients and the sector,” said Director General of EFPIA, Nathalie Moll. “The industry is working hard to find solutions to replacing and reducing PFAS, however, this will take time. A proper derogation for pharmaceuticals is the only way to achieve this, while also mitigating the risk for patients and our industry."

EFPIA says that today’s opinions fail to reflect the reality of how medicines are developed and the current availability of PFAS alternatives, “PFAS materials are essential for manufacturing processes, medicinal products, APIs, delivery devices and packaging used by millions of Europeans. Medicines and their components cannot be substituted on a one-to-one basis without going through R&D, legal and regulatory approval processes.

EFPIA says that at a time when EU leaders are calling for greater competitiveness and strategic autonomy, policy decisions should fully consider that restricting PFAS would cause significant disruption for patients, healthcare systems and companies operating in Europe.