The PFAS proposal: what is it, and where does it stand?

EU law increasingly regulates the use of PFAS, the so-called "forever chemicals". For MedTech and pharma companies, the implications are significant and some restrictions already apply.

PFAS proposal (REACH)

In 2023, five EEA-countries, including the Netherlands, submitted a broad proposal to restrict PFAS under REACH. The restriction covers approximately 10,000 PFAS substances. It is not yet law, but the process is under review. The Risk Assessment Committee (RAC) has adopted its final opinion and the Committee for Social Economic Analysis (SEAC) has adopted a draft opinion. The next step is for SEAC to finalise its opinion, after which the European Commission can formally propose an amendment to Annex XVII to REACH.

If adopted, the restriction would prohibit the manufacture, placing on the market and use of PFAS, unless specific conditions are met. The current proposal includes derogations for, among others:

• Active substances in human and veterinary medicinal products (but not other medicinal substances);
• Invasive and implantable medical devices (until 13.5 years after entry into force);
• Packaging for medical devices (until 13.5 years after entry into force).

These derogations are not permanent. Companies need to start thinking about substitution now, even where derogations still apply.

Restrictions already in force

The PFAS proposal is not the only instrument to monitor. Several restrictions are already in force and directly relevant to MedTech and pharma.

Under the POPs Regulation, PFOS and PFOA are prohibited. Medical device derogations have already expired. A derogation for the use of perfluorooctyl bromide in pharmaceutical products still exists, but is subject to the Commission's next review by 31 December 2026.

Under REACH, (C9–C14) PFCAs and related substances are already restricted. A time-limited derogation for invasive and implantable medical devices applied until 4 July 2025, and has now expired.

From 12 August 2026, the PPWR will prohibit PFAS above specific thresholds in food-contact packaging placed on the market.

What companies should do

Waiting is not an option. Companies in MedTech and pharma should:

• Audit their products and supply chains for PFAS use;
• Identify which restrictions already apply to them;
• Monitor the PFAS proposal and its derogations;
• Start planning for substitution well ahead of the Commission's final decision.

Questions about how PFAS regulation affects your products? Cécile van der Heijden and Jilles van der Hoek, Axon's Green Team, advise on EU environmental legislation, including REACH and POPs, and how it applies to MedTech and pharma.