PFAS ban ‘would raise challenges for industry’

The proposals, contained in papers published by two committees within the European Chemicals Agency (ECHA), provide for some use-specific, mostly time-limited, derogations from a general restriction. However, an expert at Pinsent Masons said businesses in sectors where PFAS use is prevalent – which include manufacturers, retailers and companies involved in construction and industrial processes – would face practical challenges if the proposals are endorsed in their current form.

• Read more: PFAS regulation in the EU

“While the adoption of a harmonised EU-wide framework on PFAS appears essential to avoid regulatory fragmentation between member states, any forthcoming regulation should also remain pragmatic and take due account of the operational, technical and economic constraints faced by industrial actors,” said Charles Bressant of Pinsent Masons in Paris.

PFAS is a term used to describe a class of approximately 10,000 fluorinated chemicals used in everything from beauty and healthcare products, to clothing, semiconductors, medical equipment, in food and drinks packaging, in cleaning chemicals, and in firefighting foam, among other things. PFAS chemicals serve different purposes – depending on the chemical and the product, they have a wide range of uses, including making products resistant to oil, water or heat, for example. Some of these chemicals are, however, known to degrade very slowly – data is not available on all of them – which has led to the colloquialism ‘forever chemicals’ being used to describe them.

In January 2023, authorities from Germany, the Netherlands, Denmark, Sweden, and Norway submitted a proposal to the ECHA to restrict the manufacture, use, and marketing of all PFAS under the EU’s Registration, Evaluation, Authorisation and Restriction of Chemicals regulation (REACH).

The Risk Assessment Committee (RAC) and the Socio-Economic Analysis Committee (SEAC) at the ECHA were tasked with considering the proposal. The RAC has now issued its final opinion (167-page / 1.86MB PDF) on the matter, while the SEAC has published its draft opinion (139-page / 1.5MB PDF). The ECHA has opened a 60-day consultation on SEAC’s draft opinion – the committee’s final opinion is expected to be published later this year.

Recent changes in the EU have required dutyholders in respect of certain hazardous substances to adopt additional risk management measures, including in some cases requiring a use management plan to be in place. The RAC proposes extending these measures to derogations from the proposed ban, including by requiring manufacturers and industrial users to have in place site-specific PFAS management plans. These must include information regarding the identity of PFAS used, a justification for their use, and results of monitoring activities to assess potential emissions into the environment.

Bressant said: “In principle, these measures would reduce regulatory blind spots and enhance management standardisation provided on the content of these management plans, which would be critical to ensure consistent implementation across member states.”

Both the RAC and SEAC have advocated for a full ban on PFAS, with exemptions being strictly limited and closely supervised.

“Such an extensive approach would necessarily require clear definitions and robust identification criteria, both to ensure legal certainty for economic operators and to prevent divergent national interpretations between member states,” said Bressant.

“The RAC also endorses the so‑called structural similarity approach, which encompasses not only PFAS themselves but also their precursors and degradation products. This is a notable element of the proposal, as it mitigates the risk of so‑called ‘PFAS‑to‑PFAS’ substitutions. If this proposal is implemented, a harmonised interpretative tool would be necessary to avoid inconsistent classifications across member states,” he added.

Products or materials benefiting from a derogation from a general ban would still face strict controls, according to the proposals put forward by the two committees. Measures include mandatory labelling requirements for products containing PFAS, while manufacturers and importers would also be required to provide “clear and easy-to-follow guidance for safe use and disposal” and report on their monitoring of emissions.

In their proposal, Germany, the Netherlands, Denmark, Sweden, and Norway had suggested that complete exemptions from a ban on use of PFAS be applied to active substances contained in biocides and plant protection products as well as active pharmaceutical ingredients (APIs) in human and veterinary medicines, arguing that any risks associated from that use could be managed under sector-specific rules. However, both the RAC and SEAC consider that such an exemption would not be justified, citing gaps in the existing frameworks over the control of PFAS emissions.

The RAC and SEAC believe the proposed ban should be subject to an 18-month transition period, with additional time-limited derogations in some cases. However, Bressant said that timeline could be challenging for some businesses: “This timeframe may prove challenging for certain industrial applications, requiring profound adjustments to supply chains and production processes. In this respect, the introduction of a mechanism allowing for justified timeline adjustments could usefully be envisaged.”

PFAS restrictions have also been under consideration in the UK. The UK’s government’s approach to managing PFAS risks was recently scrutinised by UK law makers in the House of Lords. Peers across parties raised concerns about PFAS in products including babies' mattresses, school uniforms and period products, as well as water contamination, and warned the UK risks becoming a dumping ground for products banned in the EU.

In the debate, one peer, Baroness Ritchie, asked whether the government’s PFAS plan includes an option to ban PFAS in all consumer products manufactured or sold in the UK. In response, government minister Baroness Hayman indicated that while the plan sets out the government’s approach to minimising harm and transitioning to safer alternatives, there are no current plans to consult on an outright ban. Any future proposal to that effect would be open to consultation, she said.

“When deciding what action they will take to address any PFAS risks, the Government will have due regard to the environmental principles policy statement from the Environment Act 2021, which includes the precautionary principle,” Baroness Hayman said. “We know that many PFAS have useful properties and are widely used and that some critical uses of PFAS which benefit society do not currently have suitable and sustainable alternatives available. While we see their use continuing in the near future, we absolutely have to manage any risks effectively. The PFAS plan contains action to support this transition to alternatives.”