The European Chemicals Agency (ECHA) defines its mission as working for the safe use of chemicals, together with partners. In this sense PFAS are a key file for ECHA, which has not previously received a dossier as large as this. This is as much down to the number of chemicals involved as the number of products and users.
STEP 1: Preparations and the Registry of Intention
In order to restrict the manufacture and use of a substance, a Member State will prepare a restriction dossier. In case the applicant is the European Commission, this is done by ECHA. The dossier outlines the issue and provides reasons why a chemical should be subject to a restriction. In this case, the chemicals concerned are PFAS.
As a first step, a Member State must notify ECHA that it wishes to submit a dossier. This is done by means of a Registry of Intention (RoI). After filing the RoI, the Member State has one year to submit its dossier. In this case, there are 5 countries that have jointly filed a RoI.
This does not mark the start of the process for a Member State. They will in fact gather as much information as they can ahead of this. In some cases, Member States will also organise early consultations to obtain as much input on the dossier as possible.
STEP 2: Submission of the dossier to ECHA
In its dossier, the applicant describes the properties of the substance(s), its use, the exposure and the emissions to the environment. This, in brief, is an assessment of the risks and hazards. Along with this, the applicant must indicate in its dossier what it thinks should be done to control or limit the risks. The effectiveness and practicality of the proposed measures must be also be considered. The proposal must be feasible. The applicant should consider that as part of its assessment and formulate a conclusion. Is it possible to control or limit the risks associated with the substance? Well no, evidently not.
STEP 3: ECHA to assess and issue an opinion
ECHA begins its work once the dossier has been submitted. ECHA will verify that the dossier meets the requirements and organise a public consultation. As part of this, specific questions will be put forward to obtain the required input. For example, what are the critical uses of PFAS if a broad ban is introduced? Or, how quickly would sectors be able to come up with alternatives? All comments received will be included and responded to in a ‘response to comments’ document. ECHA anticipates that the public consultation regarding the PFAS dossier will lead to many comments yet.
After this, ECHA will proceed to prepare opinions. These will be drawn up by two scientific committees – the Committee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC). These opinions are not simply views but scientifically underpinned viewpoints. The focus is on scientific quality and transparency.
The public consultation and the scientific opinions are subject to legal deadlines. ECHA is able to request extensions depending on the amount of input received. We feel providing high-quality, well-reasoned input should have priority over meeting legal deadlines. This allows ECHA to maintain its credibility and provide robust justification to the European Commission.
For clarity, the RAC and SEAC opinions are additional to the proposals already set out in the dossier. The RAC and SEAC will not repeat the analysis but confirm whether the design and justification have a solid basis and will expand on this as needed. ECHA will advise on how to organise a ban and what conditions should apply. This phase takes approximately one year.
Step 4: Submission to the European Commission
Once the step above has been completed successfully, the dossier, the opinions and ECHA’s advice are sent to the European Commission in a letter. The European Commission uses the ECHA opinions for its restriction proposal but will from time to time introduce amendments. It is ultimately the Member States who will decide on the restriction of PFAS.