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Per-/PolyfluoroAlkyl Substances (PFAS)

are a group of thousands of mainly man-made substances that are used in numerous applications in EU. Being used globally since the 1940s, PFASs have already caused contamination around the world.

Currently PFASs chemical class encompass around 10,000 congeners widely used in

  • textiles,
  • (food) packaging,
  • lubricants,
  • refrigerants,
  • electronics,
  • construction and
  • many more industries including pharmaceutical and medical ones.

Because of the duration and breadth of use, PFASs can be found in surface water, groundwater, soil, and air – from remote rural areas to densely-populated urban centres. The concern regarding PFAS is based on environmental and health considerations. The continued use of PFAS in the various applications is estimated to result in about 4.5 million tonnes of emissions to the environment in the EU over the next 30 years (2025-2055) unless action is taken. This estimate covers only the use phase, and is therefore a severe underestimation of the true emissions likely to be expected.

Timeline

In 2023, ECHA published the “Annex XV Restriction Report: Proposal for a Restriction of per- and polyfluoroalkyl substances (PFASs)”, including 7 Annexes.

As of today, the ECHA scientific committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) are evaluating the the proposal to PFAS. This evaluation is being carried out in batches, focusing on the different sectors that may be affected by a potential restriction (see below).

Sector/Topic RAC SEAC
Applications of fluorinated gases Discussion: 03/2025
Provisional conclusion: 03/2025
Discussion: 03/2025
Provisional conclusion: 03/2025
Transport Discussion: 03/2025
Provisional conclusion: 03/2025
Discussion: 03/2025
Provisional conclusion: 03/2025
Energy Discussion: 03/2025
Provisional conclusion: 03/2025
Discussion: 03/2025
to be continued in 06/2025
Medical Devices Discussion: scheduled for 06/2025 Discussion: scheduled for 06/2025
Lubricants Discussion: scheduled for 06/2025 Discussion: scheduled for 06/2025
Electronics and semiconductors Introductory discussion: scheduled for 06/2025 Discussion: scheduled for 2025

The conclusions agreed at RAC and SEAC meetings are provisional until the committees finalise the evaluation of the entire restriction proposal (including all sectors of use) and adopt their opinions. These opinions will then be communicated to the public.

2024

In 2024, the opinion of the ECHA committee on the restriction options with regard to the public consultation was expected; the Implementing Regulation on restriction of PFASs of the European Commission (EC) was planned to enter into force in 2025 (see figure below).

Figure: Timeline of the proposed regulatory process on PFASs, if total ban is avoided (ECHA 2023)

Sector/Topic RAC SEAC
Hazard of PFAS Discussion: 03/2024, 06/2024
Provisional conclusion: 06/2024
General approach to emissions estimation (including waste) Discussion: 06/2024, 09/2024
General approach to socio-economic analysis Discussion: 03/2024, 06/2024
to be continued
Consumer mixtures, cosmetics and ski wax Discussion: 03/2024, 06/2024
Provisional conclusion: 06/2024
Discussion: 03/2024
Provisional conclusion: 06/2024
Metal platin Discussion: 06/2024
Provisional conclusion: 06/2024
Discussion: 06/2024
Provisional conclusion: 06/2024
Petroleum and mining Discussion: 09/2024
Provisional conclusion: 09/2024
Discussion: 09/2024
Provisional conclusion: 09/2024
Textiles, upholstery, leather, apparel, carpets (TULAC) Discussion: 09/2024, 11/2024
Provisional conclusion: 11/2024
Discussion: 09/2024, 11/2024
Provisional conclusion: 11/2024
Food contact materials
and packaging
Discussion: 09/2024, 11/2024
Provisional conclusion: 11/2024
Discussion: 09/2024, 11/2024
Provisional conclusion: 11/2024
Construction products Discussion: 11/2024
Provisional conclusion: 11/2024
Discussion: 11/2024
Provisional conclusion: 11/2024

2023

On 22.03.2023, ECHA published the “Annex XV Restriction Report: Proposal for a Restriction of per- and polyfluoroalkyl substances (PFASs)” [pdf].  The document focuses on assessing the risks of the use of PFAS to the environment and human health and comprises two annexes, Annex A focused on manufacture and use of PFAS and Annex B is evaluating the hazards and risks of PFASs for human health and the environment.

The Restriction Report provides an evaluation of the effectiveness, practicability, monitorability, and socio-economic impacts of two proposed restriction options (ROs) under REACH. These options are considered the most suitable risk management option (RMO) for addressing the identified risks for environment and health. ECHA provides timeline of the proposed restriction implementation and currently consulting on the topic.

On 25.09.2023, the six-months public consultation on the restriction of PFASs ended. Until this date interested parties could submit their comments and ECHA published the comments on their webpage.

In the end, more than 5600 comments from different industry sectores were published on the ECHA website.

Sector/Topic RAC SEAC
Hazard of PFAS Discussion: 09/2023

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