Client alert: Does the proposed ban on PFAS in Europe affect you?

The chemical scope of the restriction proposal is defined as: “Any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it)”. The scope is aligned with the OECD definition of PFAS that was published in 2021.

There are, however, a few exceptions. The proposal document says: “This definition encompasses more than 10,000 PFAS, including a few fully degradable PFAS subgroups. As these fully degradable subgroups, which can be described by their key structural elements, do not fulfil the underlying concern of high persistence [in the environment], they are excluded from the scope.”

An exact chemical definition of the exempted subgroups is given in the proposal document.

Two restriction options have been assessed by the dossier submitters. Restriction option 1 (RO1) is a full ban with no derogations (exemptions) and a transition period of 18 months. Restriction option 2 (RO2) is a full ban with use-specific, time-limited derogations and a transition period of 18 months plus either a five- or 12-year derogation period.

The dossier submitters have stated that RO2 is the most balanced option, but further information is needed to decide upon the derogations, making engagement during the public consultation phase by affected parties important.

RO2 proposes that, from 18 months after the entry into force of the restriction, PFAS, as defined under the chemical scope above, shall not be manufactured, used or placed on the market as substances on their own, or placed on the market in another substance as a constituent, a mixture or an article in a concentration of or above:

• 25 parts per billion (ppb) for any single PFAS
• 250 ppb for the sum of PFAS, or
• 50 parts per million (ppm) for PFAS including polymeric PFAS

All uses of PFAS are covered by RO2, unless there is a proposed derogation. Importantly, the restriction proposal identifies some potential derogations that it does not yet recommend, due to what it calls a “lack of evidence”.

Companies with an interest in these derogations – or indeed that wish to propose any additional derogations that are not yet included – need to provide substantial evidence during the public consultation phase.

The potential derogations requiring additional evidence are:

• Textiles for the use in engine bays for noise and vibration insulation used in the automotive industry
• Hard chrome plating
• Foam blowing agents in expanded foam sprayed on site for building insulation
• Industrial and professional use of solvent-based debinding systems in 3D printing
• Industrial and professional use of smoothing agents for polymer 3D printing applications
• Propellants for technical aerosols for applications where non-flammability and high technical performance of spray quality are required
• Preservation of cultural paper-based materials
• Cleaning and heat transfer: engineered fluids for medical devices
• Membranes used for venting of medical devices
• Use as refrigerants and for mobile air conditioning in vehicles in military applications
• The semiconductor manufacturing process
• Non-stick coatings in industrial and professional bakeware
• Hernia meshes
• Wound treatment products
• Coating applications for medical devices other than Metered Dose Inhalers
• Rigid gas permeable contact lenses and ophthalmic lenses
• PCTFE-based packaging for medicinal preparations, medical devices and medical molecular diagnostics
• PTFE in ophthalmic solutions packaging
• Packaging of terminally sterilised medical devices
• Applications affecting the proper functioning related to the safety of transport vehicles, and affecting the safety of operators, passengers or goods

Note: The restrictions would not apply to PFAS used as active substances in biocidal products, plant protection products or human and veterinary medicinal products, as these are addressed under their respective existing regulations.

The proposed restrictions may also have implications for company owners, investors, their legal teams and other stakeholders. They underscore the importance of strategic planning and appropriately managing potential risks and liabilities, especially during due diligence and transactions, in situations where PFAS are part of operations.

Companies may need to:

• Recognise where PFAS are used in operations, and this is not always readily understood. It often requires specific expertise to make such an assessment.
• Make changes in their operations ranging from process improvements to divestitures or closure.
• Minimise the potential for lawsuits (contractual and regulatory obligations)
• Make significant investments to substitute PFAS with alternatives.