Martina Vosteen

February 6, 2023

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

The national authorities of Denmark, Germany, the Netherlands, Norway and Sweden submitted a proposal to the European Chemicals Agency (ECHA) to restrict per- and polyfluoroalkyl substances (PFAS) under REACH, the European Union’s (EU) chemicals regulation.

This article provides a summary of the proposal document and potential implications.

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Introduction

ECHA published this detailed proposal on 7 February 2023: ECHA publishes PFAS restriction proposal.

The restriction proposal "is tailored to address the manufacture, placing on the market, as well as the use of PFASs as such and as constituents in other substances, in mixtures and in articles above a certain concentration”. It proposes the broadest substances ban ever in the EU, incorporating an expanded definition of PFAS that potentially applies to around 10,000 substances. The restriction also applies to the importation of PFAS to the EU.

PFAS are used extensively in commerce and industry. Many of our clients are asking what this restriction proposal could mean for their business and its potential implications for their products or supply chain.

Timeline of the proposed restrictions

ECHA’s scientific committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) will consider whether the proposed restrictions meet the legal requirements of REACH in March 2023. If they do, the committees will begin their scientific evaluation of the proposal.

The opinions of RAC and SEAC are normally ready within 12 months from the start of the scientific evaluation. However, in view of the complexity of the proposal and the extent of information that is expected in the public consultation that that runs alongside the scientific evaluation, the committees may need more time to finalise their opinions.

A six-month public consultation period starts on 22 March 2023. ECHA will hold an online information session on 5 April via their website https://echa.europa.eu/home to explain the restriction process and how to participate in the consultation.

Important actions for clients to consider taking now

Form your team. Typically, this includes in-house key leaders, technical experts, consultants, counsel
Conduct an Operational Assessment with your team¹ . Consider using Ramboll's free PFAS Indicator tool to start finding out if PFAS may be present in your raw materials, products, process agents or process installations.
Identify significant data gaps such as analytical testing of materials, supply chain assessment, etc. An overview and assessment of analytical testing considerations can be found here: PFAS analytics report for the Norwegian Environment Agency
Address data gaps
Assess potential risks, liabilities and recommendations based on the findings of the Operational Assessment and in the context of compliance with the restriction proposal
Form a strategic plan to address risks and liabilities (eg substitution plan, comments for the public consultation in case no alternatives are available for critical applications) and prioritise implementation actions

For specific advice relative to your situation, contact Ramboll: pfas@ramboll.com

¹ This often includes a comprehensive assessment of information to identify known and potential PFAS uses that would fall within the proposed restriction.

Where PFAS are commonly used

Companies that manufacture, use, import or bring to market PFAS or articles containing PFAS in the European Union would be affected by the proposed ban.

PFAS are used in a broad set of industry sectors. A non-exhaustive summary is provided below:

Automotive industry: eg polytetrafluoroethylene (PTFE) and polyvinylidene difluoride (PVDF) as binders for coating the cathode of lithium batteries with active materials such as metal oxides
Electrical industry: eg per- and polyfluorinated gases in medium- and high-voltage switchgears
Power generation and renewable energies: eg PTFE insulations for high-voltage transformers
Semiconductor manufacturing: eg per- and polyfluorinated gases in etching processes for structuring wafers, production of solar panels
Mechanical and plant engineering: eg fluoropolymer-based seals and coatings
Medical technology manufacturing: eg fluoropolymer-based medical devices that have contact with the human body (implants, endoscopy, catheters, dialysis, respirators, anaesthesia equipment), care and surgical textiles)
Food and beverage manufacturing: eg PTFE in hoses and pipes for transporting liquids
Heating, air conditioning and refrigeration industry: eg HFO blends in refrigeration systems
Textiles, leather and apparel manufacturing: eg fluorinated polymers in non-flammable, water-, oil-, chemical- and dirt-repellent textiles
Water treatment: eg PVDF-based membranes /resistance to fluctuating composition with extreme pH values)

Highlights of the proposed restrictions

Chemical scope

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

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

Proposed derogations (exemptions)

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.

Property and transaction-related implications

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.

Ramboll can help

If you need assistance with PFAS issues, please contact us at pfas@ramboll.com.

We work with companies around the world, helping them navigate and comply with PFAS regulations, including the new restriction proposal in the EU. From advice on obligations and strategic planning to technical analysis, support and troubleshooting, we provide comprehensive compliance services tailored to meet our clients’ very different needs around PFAS, which can include:

Preparing a PFAS inventory: identification of PFAS in raw materials, products, process agents and process installations
Advice on analytical methods for PFAS testing
Developing a robust PFAS strategy based on the inventory and the implications of the restriction proposal
Identifying alternatives (substitutes) for PFAS
Supporting the public consultation phase including exposure, alternatives, and socio-economic impact assessment (in line with the “essential use concept”)

Acronym summary

ECHA - European Chemicals Agency EIF - entry into force EU - European Union FKM - Family of fluorocarbon-based fluoroelastomer materials HFO - hydrofluoroolefin kV - kilovolt mg - milligram PFAS - per- and polyfluoroalkyl substances ppb - parts per billion ppm - parts per million PCTFE - polychlorotrifluoroethylene PTFE - polytetrafluoroethylene PVDF - polyvinylidene fluoride RAC - ECHA’s scientific committee for risk assessment RO - restriction option SEAC - ECHA’s scientific committee for socio-economic analysis

The information contained and opinions expressed herein: (i) are for discussion/informational purposes only, without representation or warranty; (ii) are general in nature, may not be applicable to your particular circumstances, and cover subject matters for which information and practices may change/develop quickly over time; and, therefore, (iii) should not be relied upon for any particular circumstances without consulting an environmental professional experienced in both PFAS and the specific issues related to your matter.

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