EU: PFAS restrictions under REACH

 

The European Chemicals Agency (ECHA) has released an updated proposal to restrict per- and polyfluoroalkyl substances (PFAS) under the EU’s chemicals legislation, REACH.

This revision was prepared by the competent authorities of Denmark, Germany, the Netherlands, Norway, and Sweden, who had originally submitted the restriction proposal in January 2023.

Acting jointly as the Dossier Submitter, the five authorities have now completed their review of the more than 5,600 scientific and technical comments received from stakeholders during the public consultation in 2023. On the basis of the information collected, they revised their original restriction proposal. The outcome of this work is presented in an updated report, referred to as the Background Document, which serves as the foundation for the opinions of ECHA’s committees. This document remains open to further revision, depending on the outcome of the committees’ assessment.

As part of the update, the authorities have identified and conducted evaluations for eight additional sectors that had not been explicitly covered in the initial submission. These newly assessed sectors include:

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

Furthermore, the authorities have examined restriction options that go beyond the binary choice of either a full ban or a ban with time-limited exemptions for specific uses. These alternative approaches would establish conditions under which the manufacture, placing on the market, or use of PFAS could continue in cases where risks are demonstrated to be controllable. Such options were evaluated by the Dossier Submitter for the following areas:

• PFAS manufacturing;
• transport;
• electronics and semiconductors;
• energy;
• sealing applications;
• machinery applications; and
• technical textiles.

ECHA’s scientific committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) are currently reviewing the revised proposal. The Agency’s objective is to provide the European Commission with opinions from RAC and SEAC that are transparent, independent, and of high scientific quality at the earliest possible stage.

The final decision on whether and how PFAS will be restricted will be taken by the European Commission, in consultation with the Member States of the European Union.

Background
The initiative to restrict PFAS across the EU/EEA was developed by authorities in Denmark, Germany, the Netherlands, Norway, and Sweden. The proposal was officially submitted to ECHA on 13 January 2023, with the aim of reducing PFAS emissions into the environment and improving the safety of products and processes for human health. A six-month consultation on the proposal was held between 22 March and 25 September 2023.

At present, ECHA’s scientific committees, composed of independent experts nominated by the EU Member States, continue their evaluation of the proposal.

To find out more about chemical compliance in the EU, do not hesitate to contact the Product Compliance Institute.