On 7 February 2023 the European Chemicals Agency (“ECHA”) published a comprehensive dossier concerning a ban on around 10,000 per- and polyfluoroalkyl substances (“PFAS”). PFAS are used in many industries and present in many consumer goods. The restriction proposal aims to restrict the manufacture, placing on the market and use of substances harmful to human health and the environment, and to limit their associated risks. The ban is to be implemented under Regulation (EU) No 1907/2006 (“REACH”). An initial open consultation has been completed, and ECHA’s scientific committees are now examining the potential impacts of the restriction proposal.
Background
Because of their material properties, PFASPFAS have many different applications, such as in aerospace, for military purposes in the automotive sector, and in the manufacture of semiconductors. They are also present in everyday products such as mobile telephones, rainwear, cosmetics and cooking utensils. PFAS are especially important in industries relevant to the energy transition: they are used to manufacture membranes for hydrogen production, for solar panels, in water electrolysis to generate green hydrogen, and in semiconductor manufacturing.
Many of the approx. 10,000 substances subsumed under the term PFAS are harmful to human health and the environment. People can absorb PFAS primarily through foodstuffs (especially drinking water). PFAS can be detected in soil, animal feed and consumer goods. They are suspected of harming the hormone and immune systems and of being carcinogenic. Their chemical stability has led to them being dubbed “forever chemicals”. Once released they will remain present in the environment for decades.
“Restriction dossier” on PFAS
In view of these issues, experts from public authorities in Germany, the Netherlands, Denmark, Sweden and Norway have assessed the risks that PFAS pose for humans and the environment. In their assessment, these authorities concluded that the manufacture, use and placing on the market of PFAS entail significant risks, as does their disposal. The findings have been set out in a “restriction dossier” and submitted by the authorities to ECHA, the European Chemicals Agency. ECHA published the restriction dossier on 7 February 2023 with minor changes. The ban it envisages covers over 10,000 different PFAS. ECHA itself describes the restriction dossier as the “broadest restriction proposal under REACH so far”.
The restriction dossier formed the basis of a public consultation from 22 March 2023 to 25 September 2023. ECHA’s scientific committees (the Committee for Risk Assessment (“RAC”) and the Committee for Socio-economic Analysis (“SEAC”)) are currently formulating their opinions on the restriction dossier. RAC had previously checked the restriction dossier for feasibility. In October 2023, RAC published a statement indicating that parts of the restriction dossier were still too vague, making the restrictions’ application and feasibility problematic in practice.
In addition to the restriction dossier, a related proposal is currently on the table, namely to regulate fire-fighting foams that contain PFAS. De facto, this would constitute a ban on all PFAS in fire-fighting foams except where their use is essential for society. RAC and SEAC have already given this proposal a positive assessment, especially as suitable alternatives are available. It is now up to the European Commission to propose a corresponding regulation and decide on transposition across the EU together with the Member States. A decision is expected in 2025.
Broad scope of application
The PFAS ban is to be implemented under REACH, the EU’s chemicals regulation. According to the restriction dossier, the best way to limit the risks outlined above is to impose a general ban on manufacturing, placing on the market (including imports) and using PFAS as such or as part of other substances, in mixtures or products (above a specified concentration), doing so within the framework of the REACH Regulation. Only in this way can the import of products containing PFAS be regulated, the dossier argues.
The aim is to regulate PFAS in their entirety, including precursors, so the restriction will cover all substances that contain at least one fully fluorinated methyl group (-CF3) or methylene group (-CF2-) without any further H, Cl, Br or I atoms. All PFAS that fall within the scope of application are either non-degradable themselves or decompose into non-degradable PFAS.
This broad definition means that the restriction will include substances that have yet to be developed but contain the same structural elements. The restriction dossier therefore aims to make future use of alternative substances with similar chemical properties impossible.
Derogations
Tightly defined derogations are planned for certain substances, but the restriction does not provide for any general derogation on the grounds of “essential use”.
A few substances that fall within the definition’s scope are more easily degradable and do not fall under REACH’s persistence standards, the dossier states; these are to be exempted from the restrictions proposed. In certain areas, general derogations will apply to PFAS used as an active substance but not as a co-formulant in plant protection products, biocidal products or in human or veterinary medicinal products. These PFAS will instead be addressed in their respective special regulations and subject to reporting requirements over a 13.5 year period as regards their placing on the market. These special regulations will also be directed at the manufacturers and importers of PFAS substances, so as to gather data on PFAS use in these sectors and monitor any changes. Further derogations are envisaged for the semiconductor industry; these are currently under review.
Timeframe for implementation
The restriction dossier basically assumes that alternatives to PFAS either are or will be available in good time. The dossier sees two different ways a complete ban on all PFAS can be effected.
One option contemplated is a complete ban with an 18-month transition period after the restriction takes effect. Another option under evaluation is a ban on all PFAS bar some mostly temporary, defined and application-specific derogations for a five- or twelve-year period after the 18-month transition period.
There is also a plan for the legislation to include an unlimited derogation from implementation in certain areas of application (such as HVACR systems in buildings with security relevance).
Will the ban put companies at a competitive disadvantage?
Industry has voiced concerns that European producers may face a competitive disadvantage. While competitors in non-EU countries will continue to use PFAS and may thus achieve competitive advantages, European producers would have to do without PFAS. To minimise such competitive disadvantages, the EU intends to ensure that all products brought onto the EU market by third countries comply with the same rules applicable to European producers.
Outlook
RAC and SEAC are currently evaluating the restriction dossier (since March 2024). The evaluation started after reviewing the majority of the numerous comments from the public consultation and is to be carried out on the basis of the sectors of use described in the dossier and new sectors identified during the public consultation. In parallel, the five national authorities that developed the restriction dossier are updating the dossier based on the information obtained from the consultation.
In the coming months, RAC and SEAC committee meetings will be held on various sectors affected by the restriction dossier:
- Consumer mixtures, cosmetics, ski wax in March;
- Metal plating and manufacture of metal products in June and
- Textiles, upholstery, leather, clothing, carpets food contact materials and packaging petroleum and mining in September.
RAC and SEAC will then each deliver a final opinion on the restriction dossier. Concluding the process, the European Commission will then decide on ECHA’s restriction dossier. If the restriction dossier is indeed implemented in a formal act, the restrictions envisaged are likely to apply from 2026 or 2027 at the earliest.
As things stand, this would still affect companies in the following sectors, in particular:
- textile industry;
- kitchen utensil manufacturers (products intended for consumer use are to be produced PFAS-free as soon as possible);
- packaging industry;
- metalworking industry (especially as regards coatings) and
- cosmetics industry.
For medical technology and vehicle manufacturers, the restriction dossier recognises that PFAS can only be replaced in the long term. But this does not rule out the possibility that the restriction dossier will (i) directly prohibit individual applications in these industries or (ii) stipulate that companies in these industries must research alternatives in the years to come and start using them as soon as possible.
So companies should first check what products they use PFAS in. Depending on their respective industry, they will then need to prepare for the fact that manufacturing such products in the EU or placing them on EU markets will no longer be possible in this form, and that this change will take place in a comparatively short timeframe. Companies should then check whether they can modify their products such that these no longer rely on PFAS, and whether suitable alternatives are available on the market.
There is likely to be another consultation phase as soon as SEAC has published its report on the restriction dossier’s socio-economic impacts. This phase would enable companies to refocus attention on possible deficiencies in the restriction dossier. Companies affected should use this opportunity to ensure that European legislators can take due note of their concerns.
For these reasons, companies that use PFAS in their products or production processes should keep a close eye on developments in connection with the restriction dossier.
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