In March 2026, the Risk Assessment Committee (RAC) and the Socio-Economic Analysis Committee (SEAC) of the European Chemicals Agency (ECHA) launched a public consultation on their opinions regarding a potential EU-wide restriction on PFAS. The proposed measure would limit the manufacture, placing on the market, and use of these substances, while allowing for specific derogations. Stakeholders can submit comments until 25 May 2026.
Growing risks for human health and the environment
In its final opinion, RAC highlights that PFAS pose increasing risks to both human health and the environment due to their high persistence. According to the Committee, existing regulatory measures are not sufficient to effectively control emissions, making coordinated EU-level action necessary. Where derogations are granted, RAC recommends a set of accompanying measures, including:
- site-specific PFAS management plans for manufacturers and industrial users;
- clear consumer labelling;
- guidance on safe use and disposal.
SEAC’s draft opinion stresses that PFAS are widely used across multiple industrial applications in Europe, reinforcing the need for a harmonised EU approach to prevent internal market distortions. The Committee suggests that derogations should be limited to uses where no viable alternatives are currently available, alongside risk management measures to minimise emissions.
EFPIA raises concerns over pharmaceutical impact
The European Federation of Pharmaceutical Industries and Associations (EFPIA) responded to the committees’ opinions by highlighting the absence of explicit derogations for the pharmaceutical sector. According to EFPIA, “the absence of clear and durable derogations for medicines would compromise patient access to critical treatments and drive manufacturing out of Europe.”
The organisation notes that PFAS materials are essential in several pharmaceutical manufacturing processes, including the production of active substances and delivery devices. Moreover, replacing PFAS components is not straightforward, as it would require extensive R&D efforts as well as legal and regulatory approvals.