EU PFAS restriction
What is a REACH restriction?
- Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is the European Union Regulation dating from 18 December 2006, addressing the production and use of chemical substances and their potential impacts on both human health and the environment.
- The regulation established the European Chemicals Agency (ECHA), which manages the technical, scientific and administrative aspects of REACH.
- REACH restrictions limit, ban or set conditions on the manufacture, placing on the market (including imports) or use of a substance or group of substances.
- Restrictions are a measure for protecting human health and/or the environment from risks posed by chemicals on their own, in mixtures or in articles.
Overview of the EU PFAS restriction and timeline
What does the proposed PFAS REACH restriction contain?
- Since 2020, five Competent Authorities (MSCAs) of Germany, Netherlands, Sweden, Norway, and Denmark have been preparing a REACH restriction dossier for all PFAS. The restriction proposal was submitted to ECHA on 13 January 2023;
- REACH restriction “is considered to be the most effective and efficient way to manage such a large and complex group of substances that are used in numerous applications.” The restriction would cover PFAS manufacturing, use, and placement on the EU market;
- The five MSCAs argue that high persistence is the main concern for all PFAS along with concerns resulting from a specific combination of properties;
- They also argue that releases of PFAS are considered a risk to the environment that it is not adequately controlled.
What is the PFAS REACH restriction potential timeline (2023 – 2025)?
Note: Considering the large number of comments submitted as part of ECHA’s public consultation, it is increasingly likely that further delays will take place in the process. Additionally, in light of the strong concerns raised by a wide variety of stakeholders, it is also possible that the restriction proposal is withdrawn and re-submitted.
FPG’s position on the EU PFAS restriction
The REACH restriction dossier proposes a near total ban over time on the use of fluoropolymers in all applications, without distinguishing between fluoropolymers and other PFAS. The proposal makes limited reference of the fact that fluoropolymers have very different toxicologic profiles to other PFAS substances. Fluoropolymers have been proven safe for their intended use, and are non-toxic, not bioavailable, non-water soluble and non-mobile molecules.
Given their breadth of use, benefits to society, instrumental role in EU strategic objectives, and the lack of suitable alternatives, a total ban on fluoropolymers is therefore not proportionate. Instead, the concerns raised in the restriction proposal can be adequately managed through the implementation of different regulatory frameworks together with manufacturing and end-of-life risk management measures.
Stakeholder public consultation
ECHA’s public consultation on the EU PFAS restriction proposal closed on 25 September, with more than 5 600 comments from over 4 400 organizations, companies and individuals.
The FPG has analyzed around 3500 submissions (not all submissions have yet been uploaded to ECHA’s website) and found that more than 70% of them mention fluoropolymers. Amongst them, hundreds of contributions are calling for a derogation or exemption on fluoropolymers in light of their importance in key applications and lack of suitable alternatives.
FPG response to public consultation
FPG has shared its views on the PFAS REACH Restriction Annex XV report and the potential impacts this could have on the fluoropolymer industry. FPG believes that fluoropolymers and applications containing a fluoropolymer should be not regulated within the REACH restriction. Given their safety profile, breadth of use, benefits to society, instrumental role in EU strategic objectives, and the lack of suitable alternatives, a total ban on fluoropolymers is not proportionate. Therefore, by way of derogation, fluoropolymers and applications containing a fluoropolymer shall not be restricted. Instead, the concerns raised in the restriction proposal can be adequately managed through the implementation of different regulatory frameworks together with manufacturing and end-of-life risk management measures.
As part of our second submission to ECHA’s public consultation, we provided a number of supporting documents, including the Guide for the safe handling of fluoropolymer resins, assessment of fluoropolymers against the OECD Polymer of Low Concern (PLC) criteria (2018 and 2022), the FPG Risk Management Option Analysis (RMOA) and Socio Economic Analyses (2017, 2022 and 2023), analysis of alternatives (2023) and studies on fluoropolymer incineration and waste.
How FPG can support you
Keeping you informed
- Fluoropolymers and their key applications, including how the restriction will impact specific sectors and hinder broader EU objectives.
- Updates on the restriction process, including new milestones and how you can be involved in the process.
- Updates on FPG actions, including news and events.
- Messaging regarding FPG’s position on the restriction proposal.
Should you have any questions on fluoropolymers and the regulatory landscape surrounding them, do not hesitate to reach out to us at email@example.com
Guiding you through a complex regulatory landscape
EU policy can be a complex environment to navigate for stakeholders who are not familiar with the Union’s legislative processes, in particular when it comes to chemicals. We will continue to provide guidance on the regulatory process around fluoropolymers, in particular the ongoing EU PFAS restriction, to ensure that you can stay on top of the latest developments and be represented in the process.
Making your voice heard
We believe that the voice of our industry stakeholders should be heard and will continue to advocate for a balanced regulatory environment for all fluoropolymers across all sectors.
As the voice of the fluoropolymers industry, we can share your concerns with policymakers and other stakeholders and amplify your messaging around the EU PFAS restriction. Should you wish to be more directly involved in the process, we also invite you to participate in the joint outreach program organized by the fluoropolymer industry.
Find out more about how you can be involved here.