The PFAS restriction procedure - will the EU be PFAS-free in the future?

Definition of PFAS via CF2 and CF3 groups (Bildquelle: Information document for the Call for Evidence 2020)

In connection with various environmental damage caused by PFOA and PFOS, mainly due to the use of perfluorinated extinguishing agents, but also partly due to the use of fluorinated chemicals as additives in electroplating or polymer production (Burgkirchen, Bavaria), as well as impregnating agents in consumer products (outdoor clothing, carpets), the German Federal Institute for Occupational Safety and Health (BAuA) and four other European governmental organizations have launched a regulatory process to ban so-called “PFAS” chemicals.

The harmful chemicals PFOA and PFOS are perfluorinated surfactants that have a hydrophobic (water-repellent) fully fluorinated CF molecular chain on the one hand and a hydrophilic (water-attracting) functional carboxylic acid or sulfonic acid group on the other.

Although this property makes these substances universal additives in the aforementioned fire extinguishing agents or in the emulsion polymerization of fluoropolymers, it is also responsible for their solubility in water and thus their mobility in rivers and oceans, as well as for their bioaccumulation and potential toxicity. In addition, the fully fluorinated CF molecular chain, due to its high chemical stability, makes these substances persistent chemicals that do not decompose or degrade within a defined period of time.

As a result, PFOA and PFOS as well as their salts and precursor compounds have already been regulated and their use banned in the EU. Functionally comparable substances were then introduced as alternatives, which are similar in chemical structure but differ to such an extent that they do not fall under the PFOA and PFOS ban. In common parlance, such substances are referred to as “regrettable substitutes”.

However, some of these substances also exhibit the properties of persistence, mobility, bioaccumulation or toxicity specified in ANNEX XIII REACH and could cause corresponding damage if used improperly, just like PFOA and PFOS in the past.

To counteract this, the restriction procedure for per- and polyfluorinated alkyl substances (PFAS) was launched in the EU, in which 5 European authorities, including the German BAuA, began collecting data on PFAS in predominantly end-user-related areas of application as early as 2020 and ultimately summarized them in an ANNEX XV dossier on the restriction of per- and polyfluorinated alkyl substances (PFAS).

Originally planned regulation

By defining these chemicals, with CF2 and CF3 groups as chemical building blocks, fluorinated polymers were also included in the current restriction procedure for “PFAS”, because these polymers (approx. 30 in total) have the same building blocks as the materials designated as “perpetuity chemicals” (up to 10,000).

Restriction options RO1 and RO2 (Image source: BAuA)

Although the polymers concerned are not hazardous chemicals within the meaning of ANNEX XIII REACH, are not mobile (not soluble in water), not bioaccumulative and not toxic, but on the contrary, are proven safe materials through testing, they are to be regulated without consideration of their active hazard.

This definition of the “PFAS” substances concerned is therefore also intended to regulate materials that are essential for the operation and maintenance of industrial plants. The connection with environmental protection, e.g. through minimized emission values when using PTFE seals and membranes, was not taken into account, and the dossier even calls into question the necessary use of fluoropolymers by naming supposed alternatives.

In the proposed restriction options (RO1 and RO2), reference is also made to the possibility of developing alternatives and, when assessing proportionality, to the fact that functional alternatives would already be available for a large number of applications.

This means that if restriction option 1 (RO1) came into force, fluoropolymers would also be banned after just 18 months. In the case of RO2, extended transition periods would be possible for various applications, from 6 ½ years to 13 ½ years.

The following sectors were originally identified for the use of PFAS and published in the “Annex XV Restriction Report - Proposal for a Restriction; Version Number 2; 22.03.2023”

PFAS manufacturing
TULAC (Anm.: Textilen, Polster, Leder, Bekleidung, Teppiche)
Food contact materials and packaging
Metal plating and manufacture of metal products
Consumer mixtures
Cosmetics
Ski wax
Applications of fluorinated gases
Medical devices
Transport
Electronics and semiconductors
Energy sector
Construction products
Lubricants
Petroleum and mining

In the sector-specific analysis, the restriction options RO1 and RO2 should be applied according to the following scheme:

Publication in the European Official Journal (Image source: ECHA)

The aim was to minimize emissions to the environment by restricting the manufacture, placing on the market and use of all PFAS affected by the definition.

Public consultation

In the six-month public consultation, which ran from March to September 2023, more than 5600 comments were then submitted on the restriction procedure. Apart from some emotionally or idiologically driven comments, a large number of submissions also contained factually valuable information on the risk of PFAS and the socio-economic impact of the proposed restriction.

In personal discussions and meetings with BAuA officials, it also became clear that a large number of fluoropolymer applications from the industrial sector, such as seals, were only recognized through the submissions to the public consultation. Technical explanations and specialist information were then provided in personal discussions with a panel of experts that we had initiated in order to pursue precisely this goal in a constructive dialog.

Newly identified applications

Aware of these submissions for “public consulation” - the first opportunity to submit general comments on the ongoing restriction procedure - ECHA responded in writing on November 20, 2024, with reference to those responsible for the dossier submitters, that new areas of application had been identified and that information had been submitted that considered further restriction options than the previously proposed RO1 and RO2.

With the information submitted, further application “sectors” were identified such as

Sealing applications (e.g. seals and valves)
Technical textiles (e.g. filters and venting)
Printing applications (e.g. inks)
Other medical applications (e.g. excipients for pharmaceuticals)
Applications in machines (e.g. plain bearings)
...and possibly others

Alternative (additional) restriction option(s)

Additional restriction options, such as presumably an RO3 with permanent exemptions for certain areas of application, are likely to be subject to certain conditions.

Information will only be taken into account if it has been submitted in the public consultation.
In principle, implementable and enforceable measures, such as the fulfillment of requirements for production and disposal, will be assumed. However, this appears to be feasible via general emission limit values and the requirement for closed production systems.
A risk analysis to identify emissions over the entire life cycle of a material is being considered. Take-back and recycling systems play a key role here.

The evaluating committees

The committees RAC (Risk Assessment Committee) and SEAC (Socio Economic Analysis Committee) prepare corresponding assessments for the areas of application (sectors) specified in the original restriction proposal, as well as for all other applications that have become known through the public consultation.

RAC comments on the risks associated with the use of the respective substances. SEAC is responsible for assessing the potential social and economic impact of a restriction.

These opinions, supported by the background document resulting from the revised dossier, should then provide the necessary information for further decision-making.

Once SEAC's assessment has been provisionally completed, this committee will publish a draft opinion, which will be published together with the background document (revised dossier) available by then.

Timeline

According to the latest ECHA publications, the meetings of RAC and SEAC were held in March 2025, with the planned sectors being dealt with in full only by RAC and SEAC postponing part of them until June 2025. It remains to be seen whether RAC and SEAC will still be able to fully process the sectors in 2025.

Particularly in view of the new sectors, which play a very important economic role and whose assessment by SEAC will certainly not be easy, it can be assumed that the “SEAC Draft Opinion” will not be published until 2026.

Only then will the aforementioned 60-day public consultation follow, in which all affected parties will be asked to comment on the socio-economic impact of a restriction.

Note: Do not hesitate to submit additional, verifiable technical information in addition to your initial submission - the more true facts you submit, the more objective the result will be.

The final opinions of the RAC/SEAC committees are then drawn up and the final background document is produced. Based on all the information on the risks of PFAS and the socio-economic impact of restricting the substances, it is then up to the European Commission to submit a formal restriction proposal. The proposal is then discussed and voted on in the responsible EU committee, the so-called REACH Regulatory Committee (MSC). This procedural step represents the political decision-making process for the restriction proposal.

If the restriction proposal is accepted by the REACH Regulatory Committee, it will be published in the Official Journal of the European Union and enter into force after being examined by the Council and the European Parliament.

Will the EU be PFAS-free in the future?

On the basis of the RAC and SEAC analyses and opinions, with additional consideration of the submissions made in the second 60-day consultation following the publication of the SEAC Draft Opinion, the EU Commission must make a decision with the support of the Regulatory Committee, which consists of representatives from all member states.

Whether the overall EU regulations on PFAS bans will be adopted will certainly depend on the risk assessments and, on the other hand, very much on the consideration of the social and economic impacts. The more impacts are clarified, the more exemptions will be made in certain areas.

Accordingly, regulations will follow that not only amount to a general ban on PFAS, according to the current definition - according to the opinions of some experts, a restriction of PFAS chemicals is likely to take place, the use of which will be regulated depending on their overall hazardousness and their necessary availability.

It can therefore be assumed that PFAS fluoropolymers necessary for industry will be regulated separately according to their possible new areas of use and necessity, such as in sealing applications (RO3). Uses of PFAS chemicals that are currently not yet replaceable, such as coatings for personal protective equipment, could be subject to a time exemption of a further 5 or 12 years under RO2, depending on their replaceability.

Consumer products that are not urgently required, such as impregnations for consumers' outdoor clothing, carpets or upholstered furniture, could then fall under a general ban in accordance with RO1. To limit emissions, it is to be expected that chemical additives used in the polymerization of plastics, for example, may only be used in closed systems and are subject to strict controls - similar to the exemption for the use of already regulated PFOA precursors in pharmaceutical production

Finally, it remains to be hoped that the committees can obtain and evaluate sufficient objective information and that the final political decision does not hinder the European economy and our technological progress.