The Universal PFAS restriction: How valuable is industry input?

The European Chemicals Agency (ECHA) received over 5600 responses during the 6-month public consultation period of the Universal PFAS restriction. This is 10 times more than the previous record. To gain an understanding of how ECHA and the dossier submitters process such levels of data, FPP4EU invited representatives to our Collaboration Platform event on 20 June 2024.

ECHA is currently reviewing sectors in clusters. To work as fast as they can, they ensure the amount of information received is matched by increased resources. The next sectors to be reviewed after September include Fluorinated gases, transport and construction products.

The dossier submitters use the consultation input in their work on the background document. The starting point of this document is the original proposal, to which they incorporate the comments received on hazards/risks, new (sub)uses, interlinks with other EU regulations, alternatives (derogations and transition periods), other restriction options, and socioeconomic impacts. It is then shared with the ECHA committees for risk assessment (RAC) and socio-economic analysis (SEAC), who will use it as a basis to draft their opinions. As a final step, it is forwarded to the European Commission together with the opinions of the two expert Committees.

Dr Frauke Averbeck, Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (BAuA), representing the dossier submitters, explained: “Not each comment will be answered individually, but each one is read and considered. Fluoropolymers was a recurring topic in almost all comments. However, after checking the information received, the dossier submitters’ concerns related to fluoropolymers still exist, so they will remain in scope of the dossier submitters’ restriction proposal”.

Consultations are your communication line with ECHA

The way for industry to share data with ECHA is through public consultations. As per Bastian Zeiger Regulatory Officer, Risk Management I Unit, European Chemicals Agency: "Stakeholder inputs are important, clear submissions are key”.

The 6-month consultation period, launched when the U-PFAS restriction proposal was published in March 2023, is already over. The next 2-month consultation period will commence once ECHA’s Committee for Socio-economic Analysis (SEAC) adopts its draft opinion.

Zeiger’s advice is to group responses per sector, structure them clearly with a summary upfront, and address any questions raised, backing it all up with data and knowing that the essential use concept communication will not apply for this restriction. He also said: “Don’t wait to start assembling information. You can already find out what additional information is
required by looking at what was submitted for your sector. Specific questions will not come until later. But preparations can happen now”.

Conclusion

To make an informed decision, authorities place value on industry input. The next two-month consultation will be an opportunity for industry to share any new data not previously submitted. Given that two months is a small window, it is key that sectors already start working together to compile the data they expect will be needed in a structured manner. It won’t be an easy task, but we all have the same end goal: a balanced regulatory measure that works for all stakeholders involved.