The European Chemical Agency (ECHA) has launched a public consultation on a proposal to ban PFAS, marking the next step in what is expected to be a long and contentious battle to restrict the chemicals in the European Union.
Some 10,000 per-and polyfluoroalkyl substances, known as PFAS, could be banned in the EU under a proposal submitted to ECHA by five countries earlier this year. The proposal from Germany, the Netherlands, Sweden, Denmark and Norway, published by ECHA in February, is one of the broadest in the EU’s history. If implemented it would be EU-wide, targeting synthetic chemicals used in a variety of applications including textiles, packaging, medical products, lubricants, refrigerants, petrochemical, manufacturing, electronics, and construction processes.
The mainly man-made substances, often called ‘forever chemicals’, have been in use for several decades and have been criticised by academics, NGOs and civil society for the time they take to degrade naturally (their so-called ‘persistence’), which results in them building up in the environment, potentially posing serious health and environmental problems. National authorities estimate that around 4.4 million tonnes of PFAS, which are often used as substances on their own or as mixtures and in articles, would end up in the environment over the next 30 years unless action is taken.
ECHA is currently consulting stakeholders on the proposal. Interested parties are invited to send in scientific and technical information on the manufacture, placing on the market and use of PFAS. This is a crucial step for companies willing to seek exemptions from the rules to provide evidence on why the use of PFAS is a crucial element of their product(s). Companies have six months to submit responses.
Freshfields is supporting several entities with guidance on PFAS and how to respond to the consultation. Below we have an overview of the restriction proposal.
All uses of PFAS are covered. The proposal is tailored to address the manufacture, placing on the market and use of PFAS in different substances, mixtures, and articles. It covers the entire European Economic Area. Technically, the chemical scope of the proposed restriction 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), with some exceptions. PFAS used in products covered by other EU legislation, e.g., Plant Protection Products (PPP) and Biocidal Products (BP), are not covered by this proposal.
The proposal discusses two restriction options (ROs). RO1, a full ban with no derogations and a transition period of 18 months, was assessed. However, ultimately the proposal supports RO2 - a full and comprehensive ban with time-limited derogations for specific uses. RO2 envisages a general 18-month transition period after which PFAS may only continue to be used for specific purposes and for a period of five- or 12-years.
While nothing has been set in stone, the proposal to restrict PFAS currently envisages the following derogation periods:
Five years after transition period for the following uses:
- refrigerants in low temperature refrigeration below -50°C
- refrigerants in mobile air conditioning-systems in combustion engine vehicles with mechanical compressors
- food contact materials for the purpose of industrial and professional food and feed production.
12 years after transition period for the following uses:
- lubricants where the use takes place under harsh conditions, or the use is needed for safe functioning and safety of equipment
- cleaning and heat transfer-engineered fluids for medical devices
- implantable medical devices (not including meshes, wound treatment products, tubes, and catheters)
- fluoropolymer applications in petroleum and mining industry
- PFAS used in semiconductor manufacturing processes.
Note that some of these derogations are proposed whilst others are for reconsideration and therefore may be shortened or increased. Manufacturers and users of PFAS who do not fall within the scope of these categories need to familiarise themselves with the idea that their current business model as regards PFAS may be significantly impacted within the foreseeable future. In particular, PFAS used in consumer mixtures, ski wax, cosmetics, home textiles and consumer apparel, consumer cookware, plastic packaging, construction products, and food packaging will be banned after the 18 months transition period.
The public consultation will run until 25 September 2023. The ECHA’s two scientific committees - for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) - will then use the input to evaluate the proposed restriction and to form an opinion on it. These opinions are not likely to be ready until mid-2024 at the earliest. Once completed, ECHA submits a dossier to the European Commission to deliberate and – eventually - decide. The restriction is not expected to become effective until 2026 or 2027 at the earliest, meaning that the use of PFAS not subject to an extended derogation period may be prohibited as early as 2028.
Anyone currently relying on PFAS in their value chain should begin to consider options, which may include:
- participating in the public consultation
- seeking alternatives to the PFAS currently used
- preparing for the phase-out of PFAS in the foreseeable future.
Restricting the use of PFAS was one of the key priorities under the European Chemicals Strategy for Sustainability, which our sustainability blog previously reported on here.