EU planned expansion of PFAS restrictions
Date of publication: January 28th, 2025
In February of 2023, the European Chemicals Agency (ECHA) proposed to generally restrict the use of per- and polyfluoroalkyl substances (PFAS) covering more than 10,000 substances in the EU. The restriction was submitted following a lengthy consultation process by five countries: Germany, the Netherlands, Sweden, Denmark and Norway. This is the first time that a restriction dossier has covered such a vast class of substances, with the goal of avoiding a cascade of substitutions for substances in the same class. A public consultation on the proposal was held between March and September 2023, generating more than 5,600 comments.
In 2024, two ECHA committees – the Committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) – continued to assess the restriction proposal, focusing on assessing the impact the ban would have on different product categories. The EU's goal is to phase out PFAS, allowing their use only when they are essential to society. The restrictions are likely to apply starting in 2026 or 2027.
The EC is expected to formally present the final proposal to Member States in 2025. If passed, the proposal would be one of the largest chemical substances bans ever in Europe.
What are PFAS?
PFAS, also known as “forever chemicals” have been widely used for decades in various industrial and consumer products, such as non-stick cookware and stain-resistant textiles, for their unique properties, including resistance to heat, water, and oil. However, they have been found to persist in the environment and pose serious health risks. Exposure has been linked to deadly cancers, liver and heart impacts, as well as immune and developmental damage to infants and children. Consumers are more frequently demanding that the products they purchase are free of these toxic ingredients.
EU regulatory efforts
EU regulatory efforts
Several PFAS are already on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Candidate List of substances of very high concern (SVHC), for example PFOA, perfluorinated carboxylic acids (C9-14 PFCAs) and PFHxS. Also, Restrictions of Hazardous Substances in Electrical and Electronic Equipment (RoHS) limits the use of certain hazardous (PFAS) substances.
Additionally, some limited legislation already exists for some subcategories of PFAS in specific use cases such as water quality, PFAS in fire-fighting foams and late last year the Commission adopted a restriction on perfluorohexanoic acid (PFHxA), banning the sale and use of the chemical in consumer textiles and food packaging.
Once ECHA’s finalizes its opinions, they would then need to be sent to the European Commission (EC), which will take time to analyze and adopt a final decision at EU level. It is possible that due to the scope, the Commission would target low-hanging fruit first, however nothing is confirmed to date.
Other countries/regions PFAS efforts
Other countries/regions PFAS efforts
- United States:2024 saw several major updates in the regulation of PFAS in the US. Most notably, the Environmental Protection Agency (EPA) announced legally enforceable Maximum Contaminant Levels (MCLs) for six PFAS in drinking water in April. Additionally, the EPA set a Hazard Index MCL for PFAS mixtures containing at least two or more of PFHxS, PFNA, HFPO-DA, and PFBS to account for the fact that low levels of individual PFAS would not likely result in adverse health effects but may pose health concerns when combined. At a federal level, no PFAS is definitively banned; instead, the EPA has regulations in place to prevent companies from resuming the manufacture, import, and use of phased-out PFAS. There are also programs to encourage the voluntary phase out of certain PFAS by companies.
- TSCA- Section 8(a)(7) of the Toxic Substances Control Act (TSCA), finalized September 28, 2023, means manufacturers and importers must be prepared to report on their use of PFAS since 2011 beginning in 2025. PFAS included on the CompTox list and CDX 8(a)(7) list are subject to the rule. Companies must report how PFAS was used in the product, production volumes, disposal, exposures, and hazards, among other information. The EPA Central Data Exchange (CDX) portal opened for reporting on November 12, 2024, and companies must submit data by May 8, 2025. Small manufacturers have been granted an extended deadline and are not required to report until November 10, 2025.
- State Level- In the US, it is important to also monitor the state level where more aggressive approaches for PFAS are being adopted. Both Maine and Minnesota have adopted universal PFAS restrictions like the restrictions being debated in the EU. Other states are restricting PFAS in key consumer-facing sectors, like food packaging and cosmetics. A key market to monitor will be California; they are already restricting PFAS in numerous industries, and in 2024, a state legislator introduced a bill to ban all PFAS in the state.
- Canada:In July 20204, guidance was published in the Canada Gazette on a new PFAS reporting requirement, with a deadline of January 25, 2025. The purpose is to collect information on certain PFAS substances, either alone, in mixtures, products, or manufactured items in Canadian commerce for the calendar year 2023. This information will be used to establish baseline commercial use data and support future activities related to the class of PFAS. This includes imported goods. Foreign suppliers are encouraged to inform their Canadian customers (that is, Canadian importers) that they import a reportable substance and may meet the reporting criteria of the notice.
- APAC:In major counties such as S Korea, Japan and China, the general trend has been to follow the Stockholm Convention when it comes to PFAS. This is probably most notable for China which is a major chemical producer. So far it does not appear that countries in the APAC region are moving to a broader ban of PFAS yet and approaches are more targeted to specific industries.
How to prepare
As with many other supply change risk requirements, PFAS regulations require companies to have robust supply chain visibility. They will need to identify all business partners that are involved in manufacturing products and their sub-components, from raw materials to manufacturing and packaging. Then, they must collect evidence that PFAS are not being introduced at any step of the way. Additionally, they should audit suppliers and test products on a regular basis and have corrective action plans in place when assessments fail to meet requirements.Managing compliance with PFAS regulations is yet another example of how the regulatory landscape is becoming more dependent on having supply chain transparency and traceability beyond just tier 1 suppliers. Risk can be introduced anywhere in the supply chain. Having solid due diligence processes in place are mandatory for GTM compliance.
Conclusion
Conclusion
Restricting the use of PFAS is one of the key priorities under the European Chemicals Strategy for Sustainability. It is therefore expected a PFAS ban will come into effect in the foreseeable future. The European Commission commits to phasing out all PFAS, allowing their use only where they are proven to be irreplaceable and essential to society. Anyone currently relying on PFAS in their value chain should closely follow developments around the proposed PFAS ban in the EU, as well as other countries and states. Companies should assess the relevance of PFAS for their products and services, consider alternatives and prepare for the phase-out of PFAS in the not-too-distant future.For more information on how ONESOURCE Global Trade solutions can assist you in managing supply chain risk and regulatory compliance, contact your Account Manager or Client Services Manager.