PRINTING APPLICATIONS INCLUDED IN PFAS RESTRICTION PROPOSAL

The European Chemicals Agency (ECHA) recently published an update on the progress of the restriction process for per- and polyfluoroalkyl substances (PFAS). Elaine Campling, Chair of ESMA Health, Safety and Environmental Protection (HSEP) Committee, reports.

PFAS are a large group of synthetic chemicals characterised by strong carbon-fluorine bonds, which make them resistant to chemical breakdown. These strong carbon-fluorine bonds and resistance to degradation has resulted in their wide use across a number of sectors. However, their wide use also results in an accumulation of PFAS in the environment. They are also readily transported, resulting in their detection long distances from the source of their release. PFAS are associated with contamination of groundwater, surface water and soil. 

In January 2023, the national authorities of Germany, Denmark, the Netherlands, Norway and Sweden submitted a restriction proposal under REACH, Regulation (EC) No 1907/2006 on the registration, evaluation, authorisation (and restriction) of chemicals. The original restriction proposal covers more than 10,000 substances across a wide sector of uses. 

ECHA’s scientific committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) are responsible for evaluating the restriction proposal. The evaluation is being carried out in stages, focusing on fourteen different sectors of use, as well as manufacturing of PFAS and ‘horizontal’ issues. 

However, the National Authorities recently updated their restriction proposal, following feedback from a six-month public consultation. The consultation received significant responses from all stakeholder groups including Industry, NGOs, institutions, academia, national authorities, agencies, and the public.

The information received led to the identification of a further eight sectors of use, which have been assessed and incorporated into the ‘Background Document’ supporting the restriction proposal.

These eight further sectors identified are:

  • Printing applications;
  • sealing applications;
  • machinery applications;
  • other medical applications, such as immediate packaging and excipients for pharmaceuticals;
  • military applications;
  • explosives;
  • technical textiles; and
  • broader industrial uses, such as solvents and catalysts.

According to ECHA, the RAC and SEAC will not be undertaking separate evaluations for the newly added sectors to avoid delaying the original 2026 target for finalising their Opinions. However, the eight new sectors will be integrated into the regulatory framework through horizontal risk management measures. The original fourteen sectors, combined with PFAS production, already account for more than 90% of PFAS emissions and usage in the European Union.

According to the latest timeline, the full scientific evaluation of the restriction proposal is expected to conclude by the end of 2026, followed by legislation from the European Commission. The revised timelines are anticipated, as follows:

  • Technical discussions on the original 14 sectors and cross-cutting issues expected to be concluded by the end of 2025.
  • A second public consultation will be issued in the first half of 2026.
  • A final joint Opinion is expected to be submitted to the European Commission in 2026.

More information at echa.europa.eu/-/echa-announces-timeline-for-pfas-restriction-evaluation

Join us at ESMA HSEP Committee meetings. For the next dates please check esma.com/committees/hsep

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