On 7 February 2023, five European countries (Denmark, Germany, Norway, Sweden, and the Netherlands) submitted the EU PFAS Restriction Proposal, which seeks to ban the use and manufacture of all PFAS chemicals as identified according to the OECD definition. The current form of the proposal, published by the European Chemicals Agency (ECHA), defines most PFAS as being very persistent in the environment; Therefore, action is needed to reduce environmental emissions and make products safer for consumers. While not all PFAS are long-lived, these five countries argue that breakdown products will be. Unlike other regulations, particularly those seen in the US, the EU proposal does not specifically define sectors or product categories but is proposing a “blanket” ban for all PFAS.
While there is significant evidence to suggest that there are no viable alternatives available at present, the restriction proposal allows for 5 and 12-year derogations (i.e., PFAS in aerospace and medical devices). The expectation, while potentially unrealistic for many applications, is that after such time, all applications of PFAS should identify alternative technologies that are safer for consumer, professional, and industrial use. There are occasional examples of non-time-limited derogations for what might otherwise be considered as ‘essential uses’, although the term is not used in the proposal, since it is undefined in the current EU Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) text.
Current landscape for PFAS legislation in Europe
Unlike countries such as the United States, where regulations are only starting to emerge, PFAS has been a topic of regulation in Europe for the past several years, with various agencies and legislative proposals seeking to act. PFOS and PFOA, two of the most prominent long-chain variations of PFAS, have been restricted under the EU’s Persistent Organic Pollutants (POPs) Regulation since 2010 and 2020 respectively. In June 2022, PFHxS was also included in the Stockholm Convention, with other chemical variants expected to follow. In January 2022, ECHA also introduced a restriction proposal for the use of PFAS in firefighting foams. The current evaluation of this proposal is seen as an important milestone in the trialing of various approaches and frameworks which can influence broader bans on the chemical class.
Apart from the firefighting foam measure, the REACH regulation has also designated several PFAS chemicals as Substances of Very High Concern (SVHC) such as PFHpA, PFBS, and GenX. This designation has been based on the risk profile of persistence, bioaccumulation, and toxicity (either PBT or vPvB), but has more recently expanded to consider mobility as an alternative concern to bioaccumulation (PMT or vPvM). However, expanding the current risk profile to an entire class of chemicals is difficult and unprecedented, in part due to the limited amount of data on specific chemistries. Despite the risk, the European Commission and several member states decided that additional action needs to be taken in line with the precautionary principle and more proactively act against the general threat of PFAS.
The UK handling of PFAS
The UK’s Health and Safety Executive (HSE), no longer subject to the legislation proposed for EU member states, has looked at the recent regulatory proposition and is considering a ban on a smaller group of PFAS that would narrow the scope of the Restriction proposal to “hundreds” of substances based on impact to health and the environment. Several stakeholders consider this approach to PFAS to be far more practical, relying more on specific evidence related to hazard and risk for each chemical, and identifying gaps where further evaluation should be required. Part of the legislation may involve drinking water standards, disposal guidelines, and restrictions on manufacturing for certain product categories.
Although this regulation is still in its early stages, it is a key component of the UK REACH work program for 2023-24 and is likely to be the subject of major industry attention both inside and outside the UK.
Limitations and challenges to the EU proposal
Critics of the proposed legislation argue that there is not sufficient evidence to the existence of viable alternatives to PFAS in many industries, and that derogations are not available for many applications where PFAS are critical to the performance of the final product. Another proposed approach may aim to identify PFAS uses that are ‘critical to the functioning of society’, provide a benefit that cannot be found through other alternatives, or result in additional risks to the industry or society through banning the chemicals. However, it is not yet confirmed who would make these subjective decisions.. Supporters of the EU Restriction Proposal advocate for early and robust alternative assessments, and that through the appropriate application of research, less hazardous substitutions for PFAS can be found without the need to give a “free pass” to certain industries.
Many EU countries are questioning the enforcement of the proposed regulations, which historically are a responsibility of the member states with guidance provided by the Commission. Detection of PFAS in products is already a significant challenge, with many voices stating that effective enforcement of the ban would be a practical impossibility.
Anthesis can help
The EU Restriction Proposal represents one of the most ambitious chemical regulations of the past decade and sets the groundwork for applying broad restrictions to entire chemical classes in the future. The European Commission has now initiated a long period of feedback and potential revisions to the proposal, which should result in a more robust regulation prior to adoption. Although the attitude towards chemicals of concern and the push to alternatives is well-justified in some cases, it remains important to carefully analyse all options to avoid regrettable substitutions, since many of the current uses of PFAS are based around their persistence.
Anthesis recognizes the importance of balancing the necessity for action with the application of well-researched alternative assessments to understand potential implications and drive impact. Our experts are continuing to track regulatory changes and updates so we can help our clients navigate the landscape and prioritize strategic actions for their business. We can help direct our clients as they navigate PFAS in their portfolio through strategic roadmapping, impact analysis, supply chain evaluations, alternative assessment, and chemical management systems. Anthesis is committed to a holistic approach to address chemicals of concern and drive industries to create a positive impact.
