ECHA unveils 6-month plan to evaluate universal PFAS restriction proposal

Regulatory background

• Per- and polyfluoroalkyl substances (PFAS), which are commonly used in textiles, impregnation agents, paints, firefighting foams (AFFF) and many other applications, have been linked to an increased risk of certain cancers, developmental effects and immunosuppression. These carbon-fluorine bonds are some of the strongest organic bonds, meaning that PFAS resist many common environmental stressors, including heat, water and oil. Consequently, many of these substances do not break down easily in the environment and exhibit a troubling capacity to accumulate in organisms. This extreme durability over time has resulted in the nickname “ forever chemicals.” Likewise, some have the propensity to travel great distances via air and sea currents, presenting a collective action problem that concerns the entirety of the EU.
• ECHA published a proposal in February 2023 placing a universal restriction on PFAS under Regulation (EC) 1907/2006 on the registration, evaluation, authorization and restriction of chemicals (REACH). With the publication of this Annex XV restriction dossier – prepared by the competent authorities of four EU member states (Denmark, Germany, the Netherlands and Sweden), and the European Economic Area (EEA) member, Norway – the EU initiated a yearslong process intended to result in the ban of this large class of substances that are widely employed across many different sectors of the bloc’s economy. [See AgencyIQ’s in-depth analysis of this restriction proposal here.]
• A subsequent, six-month public consultation that ended last September elicited more than 5,600 stakeholder comments, an unprecedented amount of feedback, the lion’s share of which originated from companies and trade associations.
• ECHA’s committees for risk assessment and socio-economic analysis, RAC and SEAC, are now reviewing the restriction dossier, with the aim of each body issuing an opinion on the proposal at an unspecified future date. Simultaneously, the five submitting authorities of the restriction dossier are in the process of updating the initial proposal to address the large volume of stakeholder feedback that they continue to review.

Now, ECHA has announced the steps it will take to evaluate the restriction proposal over the next six months

• ECHA published an announcement on March 13, outlining the steps that the RAC, SEAC and five dossier-submitting countries will be taking to process the restriction dossier over the next six months. ECHA emphasizes that its committees and the dossier submitters will continue to concurrently review the comments received on a sector-by-sector basis. The ECHA committees plan to address the first round of topics based on this sector-by-sector approach in their next three meetings.
• The table below lays out the points that RAC and SEAC will discuss during the upcoming meetings, including use applications, sectors and other topics related to the restriction proposal.

• As the regulators progress through the stakeholder feedback, ECHA intends to communicate its activities related to the restriction process. The agency stresses that the individual steps in this process will be announced in parallel with the committee meetings.

Next steps

• ECHA, the Commission, and the dossier-submitting countries have, for the most part, refrained from providing a concrete timeline for completion of the PFAS restriction. For example, when ECHA received the restriction proposal in January 2023, it published a timeline that intentionally left blank the dates for delivery of its committees’ proposal evaluation and adoption of opinions, as well as the date when the opinions were expected to be forwarded to the Commission for a final decision on the proposed blanket restriction. At that time, only the Dutch competent authority (one of the five dossier submitters) ventured to speculate about the end of the process, stating that the ban was “expected to enter into force in 2025.”
• In its March 13 announcement, ECHA states that it is “making every effort to progress opinion making, following the updates made to the proposal by the five national authorities,” and vaguely promising to “deliver the final opinions to the European Commission in the shortest possible timeframe while ensuring their transparency, independence and high quality.”

Featuring previous analysis by Rayan Bhargava.

To contact the author of this piece, please email Scott Stephens ( [email protected]).
To contact the editor of this piece, please email Chelsey McIntyre ( [email protected]).

Key Documents and Dates

• Next steps for PFAS restriction proposal, ECHA press release (March 13, 2024)