Americas
Steve Washburn
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.
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)
Initial inspiration from: Publication (bdi.eu)
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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Email us at pfas@ramboll.com or contact your local expert.
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For more than two decades, Ramboll has helped clients around the world resolve their most critical PFAS issues. Our multi-disciplinary expertise and experience has been instrumental in assisting clients in reducing a wide range of risk and liabilities related to PFAS source treatment and control, site remediation, product safety and stewardship, regulatory compliance and environmental due diligence.
For more information on Ramboll’s experience and capabilities, see www.ramboll.com/pfas