With terms like the ‘forever chemical’ or the ‘new asbestos’ thrown around, few chemical substances have been more in the eye of the storm than PFAS (per- and polyfluoroalkyl substances). It was therefore not a big surprise when six member states of Europe’s Chemicals Agency (ECHA), submitted a proposal to restrict the use, production and import of effectively all PFAS substances in Europe.
This blog post will analyze the EU’s PFAS restriction proposal, its clear merits, challenges and the specific case of fluoropolymers, a group of substances with widely used applications and a different toxicological profile than other PFAS. Furthermore, this blog post dives into the status of the restriction process and possible implications for your business.
An introduction: how I learned to stop worrying and love the molecule
The PFAS group is a family of chemical substances comprising over 4700 synthetic different variations and substances. They have been widely used in many industries, ranging from highly specific and technical applications such as energy installations and vehicles to more well-known appliances such as the famous non-stick pans and water repellent hiking gear. Arguably, even better known are the grave environmental consequences linked to the group, or at least to a number of specific substances within the group. This last fact is what drove a groundbreaking proposal to restrict the substance within the EU, a proposal which left businesses, interest groups, as well as environmentalists and policymakers with many and various questions.
Let’s start with the one centrepiece of the debate: the PFAS group, over 4700 substances mostly with one important common denominator: extremely high persistence and durability. This tells us two things: their extreme durability made it highly valuable as well as enduring in nature, and with 4700 different substances, quite some diversity can be expected.
Durability
Any material that shows far stretching resistance in highly arduous circumstances is likely to be in high demand in industrial and economic applications. Add to that the hydro- and lipophobic qualities of many substances in the group, and the result are substances that prove highly valuable in a vast number of highly specific applications. And soon enough, as one would expect, the global economy vastly shifted to this new polymer gold as certain substances gained crucial roles in high-end industries such as transport, chemicals and consumer product sectors.
It was not all gold that glittered, however. This meant that PFAS molecules started to accumulate in the environment due to their persistency, spreading to different environments, organisms, and ultimately to our own bodies.
Diversity
The number of different substances that can be qualified as PFAS is large, very large. There is no doubt that, clearly, a number of these are damaging to environment and human health. The accumulation of molecules such as PFOS and PFAO in the body can lead to decreased fertility rates, liver afflictions, certain birth defects and cancers.
Other members of the PFAS group do not show the same risk pattern, fluoropolymers are the most important example in this case. While also highly durable, and therefore persistent in nature, these groups do not show the same adverse effects on health.
The EU’s PFAS restriction proposal: what is it all about?
On 13 January 2023, the Netherlands, Germany, Denmark, Sweden, and Norway submitted a landmark proposal to ECHA to restrict the use, import and production of PFAS substances. The proposal is motivated by the increasing worry over the lasting impact these chemicals have on the environment and health, caused by their persistent nature and high prevalence. This led to a number of high-profile environment and public health scandals in a number of these countries.
This restriction proposal is remarkable for a few reasons: firstly, the submitters equate the persistence of PFAS in nature to harm and damage. This is a markedly different approach to some other proposals, where clear indicators of harm and damage had to be demonstrated. The current proposal uses the well-documented persistency of all PFAS to warrant a restriction for the entire group.
This leads us to the second reason: the enormous scope, covering virtually the entire PFAS family and all use cases. In principle, according to the proposal, over 4700 substances are in line to be banned in the EU within 18 months after publication. This means the number of sectors affected is enormous, as indicated by the record number of over 5600 responses submitted to the public consultation.
A large source of dispute is the role of fluoropolymers within the proposal. In an open letter, a broad coalition of sectoral associations, including among others AmCham, Plastics Europe and Hydrogen Europe, criticised the inclusion of fluoropolymers in the proposal and called for them to be exempted. On the other hand, NGOs and associations including CHEMTrust, Chemsec, European Environmental Bureau and Greenpeace argue that the inclusion of fluoropolymers is well warranted and support a strict implementation of the restriction proposal to guarantee a full phase out of all PFAS.
This on its own has led to unprecedented delays in the restriction process within ECHA. Whereas its principle advisory bodies – RAC and SEAC – were normally expected to deliver a first opinion within 9 to 12 months after publishing, there is still no real end-date in sight in that regard.
A proposal to restrict a chemical within the framework to REACH can be submitted to ECHA either by the European Commission or by a grouping of ECHA member states.
For ECHA to deliver its opinion on a REACH restriction proposal to the European Commission, the public consultation is to be evaluated by two consultative bodies:
- Committee for Risk Assessment (RAC): takes into account whether the proposed restriction is adequate to reduce risks to humans and environment caused by the substance in question.
- Committee for Socio-Economic Analysis (SEAC): takes into account the socio-economic information submitted to REACH via the consultation to bring economic and societal consequences of a restriction into the picture. The SEAC draft opinion is open for a second, shorter, public consultation.
ECHA delivers the RAC and SEAC opinion to the European Commission (DG GROW). After a check for compliance with WTO rules and approval by the Council and Parliament following a comitology procedure, the Commission will introduce the restriction via an amendment to the list of restrictions in REACH.
The number of contributions can partially be explained by a third factor: the strict and sector-based approach in which possible derogations have been set up. In principle, the proposal does not leave an option for any permanent exemptions. Options for derogations in time, of either six or twelve years, are based on sectoral applications and dependent on crucial factors such as lack of an alternative and contribution to safety.
The case of fluoropolymers: unique properties, particular risks?
Much of the public debate on the restriction proposal has been spurred by the inclusion of the fluoropolymer group. At a first glance this makes sense, for fluoropolymers are indeed part of the wider PFAS and share their properties of high persistency in nature. Additionally, the risk exists that different PFAS might be emitted during the production of fluoropolymers, while the risk of pollution during the end-of-life stage remains.
Production facilities for fluoropolymers have therefore been a cause of concern: poor handling of emissions and waste management has caused concrete health concerns to their direct environments, leading to recommendations for local residents to, for example, no longer consume home grown vegetables.
However, there is one important caveat: fluoropolymers themselves have not been shown to have toxic properties, unlike the well documented PFAS cases. Additionally, because of their unique durability and resistance to highly arduous and demanding circumstances, as well as distinct hydro- and lipophobic properties, fluoropolymers became crucial to several complex industrial applications.
Fluoropolymer seals prevent dangerous and polluting leakages on key applications such as chemical plants, offshore oil-and gas rigs and large shipping vessels. The highly sterile qualities of some fluoropolymers make them highly valuable for the medical and food sector while durable fluoropolymer tanks, tubes, wires and pipes have a crucial role in key sustainable technologies such as hydrogen, wind and solar energy, energy storage, electronics and sustainable transport.
Regulating fluoropolymers: to ban or not to ban, but is that the question?
This caused a general worry among industry representatives: while all agree that PFAS require a proper regulation and toxic substances should be banned from the European market, several associations and coalitions call for caution when it comes to outright banning fluoropolymers. For many crucial applications, there is no real alternative available on the market, while companies have already spent considerable sums on R&D to develop replacements since fluoropolymers are notoriously expensive.
Fear exists that a ban might therefore hamper a number of key economic sectors, especially within the field of net-zero technologies, clean transport and tech – crucial sectors in which the EU is already struggling to conserve its competitiveness on the global market. Consequences could be various: from companies departing the EU or leakage effects, as feared within certain transport sectors, to a slowdown in key innovative fields of clean energy and tech. The long delay during the current process only contributes to this sense of insecurity for investments.
While a good case can certainly be made for regulating fluoropolymers with regards to their, production, emissions and end-of-life stage, for example through stronger standards for production facilities, the question has been raised whether a full ban is the most efficient and proportionate approach. This led a number of associations to call for a full exemption for fluoropolymers from the EU’s PFAS restriction proposal, which subsequently received considerable criticism from opponents. This gets us to the crux of this debate: when balancing the harm of keeping the European market open for fluoropolymers with the economic harm of a ban, certain crucial grey areas are often glossed over in an increasingly polarised debate.
Next steps for the EU’s PFAS restriction proposal
Where this debate will end is very much up in the air. The ongoing REACH restriction process seems to find itself on truly uncharted territory as most of the existing deadlines and working methods ended up in the bin. ECHA, the dossier submitters and the RAC and SEAC are currently still evaluating the proposal as they muddle through the enormous number of contributions.
All we currently have is a brief schedule for 2024 delivered by ECHA, where the upcoming RAC and SEAC meetings will be following a sector by sector approach, starting with those which received the least comments. Therefore, the most contentious sectors, especially transport and chemicals, do not yet have a target date. Where exactly does the full SEAC report, which should be eligible for a 60-day consultation period where stakeholders can share their opinion, lands in all this, is not yet clear.
In theory, ECHA will eventually deliver the RAC and SEAC opinions to DG GROW, which will propose a subsequent amendment to the list of restricted chemicals. After a check for WTO compliancy, the proposal is delivered to the European Parliament and the Council following a comitology procedure, which can either approve or oppose, after which the decision is published in the journal.
Photo source: ECHA
Towards a new set of rules?
As part of its Better Regulation Provisions, the European Commission is currently revising the REACH Regulation. For this purpose, a consultation was already launched in 2022.
The revision sets out to update and improve several facets of the current REACH procedure to make it a better fit for today’s needs for effective chemicals regulation. With regards to the restriction procedure, the revision means to resolve the slow nature of the process. In general, the revision will aim at registration, evaluation and authorisation procedures that are more flexible, swift, less complex and provide better communication with the sectors.
One of the possibilities is, for example, a fast-track method to regulate substances that are persistent. Another concept that could be introduced is ‘essential use’, potentially opening the door for harmful chemicals to be allowed in specific applications that are shown to be essential for society.
Initially expected to be published in 2023, the revision will likely be announced by the European Commission during its next mandate.
And the EU’s PFAS restriction proposal?
The proposal was submitted before the publication of the REACH revision, which means that the revision should not affect the already ongoing restriction process. Essential use, which was often raised by stakeholders as a valuable concept in the context of PFAS, was for example clarified to not yet be applicable to the PFAS restriction proposal.
Several industry groups do hope to see fluoropolymers to be exempted from the current proposal, or to be regulated by more specific, separate legislation. Although highly hypothetical, any such future proposals could be covered under the revised REACH stipulations.
Preparing your business for the EU’s PFAS restriction proposal
In the past year, the number of sectors that realised they would be impacted has continuously expanded. PFAS in general, and fluoropolymers specifically, are widely used in a great deal of applications. If for example, you are active within the transport, electronics, clean energy, chemicals, or fossil fuels sectors, to name a few, chances are PFAS find themselves somewhere in your value chain. Considering the strict approach of the proposal, replacements might be slow and costly.
Possible consequences can be various. Within global transport chains, a real risk exists that companies will opt for repairs outside of the EU, hurting the ship and airplane maintenance and repair sector. Insecurity with regards to the availability or replacement of certain fluoropolymer applications which secure and enable complex applications could furthermore deter investments in emerging industrial sectors such as space, clean tech and fuels.
Currently, the legislative process certainly finds itself in a highly unclear situation, but it is most likely that in the end, at least the vast majority of substances within the PFAS family will effectively be banned. For fluoropolymers this is arguably a little less certain, the chance that the restriction on these will also be effectuated is nonetheless also tangible, and precautions are therefore prudent.
For now, Publyon recommends a few cautious steps:
- Reach out to down- and upstream partners to verify whether they use substances which belong to the PFAS group
- If you, or a partner, make use of chemicals in the PFAS group, inquire:
- If a proper management plan is in place to reduce emissions and risks of leakage into nature.
- If the substance is essential, inquire whether a contingency plan for replacement is in place?
- If the application is essential and non-replaceable, we recommend to remain in contact on the matter with legislators, respective environmental authorities and relevant sector associations. To remain informed and make your own input known is crucial to anticipate a possible ban and its consequences. A few essential policy moments are ahead, each with their opportunities for influence and reach-out, clarification or dialogue.
- SEAC’s draft opinion will be followed by a second public consultation, a key moment to submit additional data to the regulator.
- DG GROW will introduce the restriction on the ECHA report, which is not necessarily a one-on-one copy. While the DGs are reluctant to speak with too many concerned parties, they do seem aware of the wide societal impact and are preparing themselves for reach-out by worried sectors.
- The European elections are fast approaching, which will likely lead to a reshuffle of the political priorities of the European Commission and parliament alike.
Publyon is specialised in supporting businesses in finding their way when posed with these challenges. Publyon has a proud track record on supporting businesses which want to get in touch with European policymakers and has been actively involved on the restriction proposal since its inception. If you have questions or need support, use the form below to reach out to our experts.
Do you want to know more?
Do you need help getting a better understanding of what the EU’s PFAS restriction proposal will mean for your organisation?
Fill out the form below and our team of experts will get in touch with you.
