New restrictions on the use of of per- and polyfluoroalkyl substances in the EU are imminent and there is increasing pressure from customers and investors to substitute these ‘Forever Chemicals’. Many businesses and their customers will be impacted by these changing regulations – some severely – so a proactive stance on preparations makes excellent sense. However, with specific details either ambiguous or still under discussion it’s hard to know where to start.

On 13 January, the national authorities of Denmark, Germany, the Netherlands, Norway and Sweden submitted a proposal to ECHA to restrict PFASs under REACH, the European Union’s chemicals regulation. With the detailed proposal to be published on 7 February 2023, our experts in chemical compliance, stewardship and sustainability consider how learnings from established PFAS regulations can inform preparations for emerging and evolving requirements.

TSG Consulting has identified five tips to be PFAS-restriction ready, detailed below:

1. Know your products, manufacturing processes and supply chains
2. Obtain the right expert input
3. Develop a robust testing strategy
4. Engage thoughtfully in public consultations
5. Keep appraised

New and complex regulation

Companies that manufacture or rely on PFASs face a blast of new and complex regulation aimed at reducing use and exposure. Thousands of chemicals are targeted; and though many can be replaced without major consequence, others currently play a critical role in the products and applications in which they are used. Use in some industry sectors – including cosmetics, textiles, consumer goods and electronics – is well documented. However, the potential for greatest impact may be in niche uses or critical sectors (e.g., medical devices, pharmaceuticals, aerospace and energy) where the use is less obvious, yet essential, and technically or economically challenging to replace.

Widely referred to as ‘forever chemicals’, a key concern with PFASs is their persistence and widespread presence in the environment, often being found long distances from their source. The potential for many PFAS to bioaccumulate, and concern regarding their toxicity, serve to intensify concerns. Almost 20 years since the Stockholm Convention entered into force to focus on reduction of some of the most well-known Persistent Organic Pollutants (POPs), scientific evidence on PFAS is still evolving. Scrutiny continues to intensify, with new restrictions being implemented in the European Union (EU), recent updates to health advisories in the USA, and measures being discussed at a global level. Historically, attention has focused on specific PFAS, but the forthcoming EU initiative aims to phase out all PFASs unless their use is essential.

Many organisations are already looking at ways to assess and reduce their reliance on forever chemicals, but there is rarely a simple fix. PFASs are often selected because they hold desirable properties that are not easily replicated with alternative ‘drop in’ substitutes.

Existing, evolving and emerging PFAS regulations

PFAS use is already regulated around the world, and in the EU, by various legislative instruments including the EU REACH Regulation. In the EU, several PFAS including PFOA and its salts are on the REACH Candidate List. Some are already subject to REACH restriction. PFOS and PFOA are covered by regulations that implement the EU’s commitments under the Stockholm Convention. Still, the new REACH restriction is anticipated to be a game changer.

A good understanding of the regulatory landscape related to PFAS is essential so that effective strategies for compliance and product development can be made. It may be possible to make material contributions during consultations that influence regulatory detail. Understanding how the regulations apply, where exemptions can be applied, what to do when substitution is not possible and which essential uses are threatened will be critical.

The European Chemicals Agency (ECHA) has published an overview of how PFASs are currently regulated in the EU here. It encompasses the existing and imminent global, and REACH, requirements on specific PFAS types including:

• Perfluorooctane sulfonic acid and its derivatives (PFOS)
• Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds
• PFHxS, its salts and related compounds
• Perfluorinated carboxylic acids (C9-14 PFCAs), their salts and precursors

At present, all eyes are on the EU’s draft restriction regarding the manufacture, marketing, and use of all PFASs, due to be published on 7 February 2023. An anticipated contentious issue with this broader restriction is a lack of clarity on what will constitute ‘essential use’. This is just one of several factors that make it difficult to prepare for the changes. However, analysing obligations, exemptions, and processes for existing PFAS requirements can yield valuable insights to shape and inform activity. A lack of specific information doesn’t have to prevent early progress being made.

In parallel with activity around the new PFAS restriction, many binding terms for an existing restriction on a sub-set of PFAS (C9-14 PFCAs) will come into effect from 25 February 2023 (entry 68 of Annex XVII to REACH). The current restriction is the result of an evolving process and may indicate what lies ahead for the broader PFAS restrictions. From our own analysis of regulation to date, we offer five tips that could aid preparations.

1. Know your products, manufacturing processes and supply chains

A full characterisation of product composition will be required for manufactured and imported substances, as well as mixtures and articles, to enable and demonstrate compliance with new restrictions. This can only be achieved when manufacturers and importers understand where PFASs are likely to be present. This means intimate knowledge of products and production processes, including those of suppliers, in addition to an understanding of where and how inadvertent contamination might occur in the supply chain.

2. Obtain the right expert input

Determining whether PFAS are present in a product – whether by design or inadvertent contamination – is no mean feat. It requires consideration of potentially thousands of chemicals, and confirming whether a product contains those affected by restrictions requires a significant depth and breadth of knowledge.

Guidance is likely to be needed to help identify the scope of impacted substances, especially when the restriction does not indicate specific substance identifiers such as CAS or EC numbers. This challenge is compounded by the fact that suppliers won’t always be able to supply the necessary information in a reliable or timely way.

It takes time and effort to manage and correct these issues within supply chains, especially when they span different countries. Specialist expertise in PFAS chemistry, analytical data, product composition, and relevant regulations is critical in the development of a robust response. On top, an enterprise-wide response involving inputs from procurement through quality and operations will be required to manage this issue.

3. Develop a robust testing strategy

Testing of goods that may contain or be contaminated by PFASs is likely to be required. In some cases, routine testing will be necessary to prove that any trace amounts PFASs don’t exceed certain levels, in others it may be necessary to demonstrate the absence of these chemicals.

Robust analytical methods and a lot of pragmatism will be required to accommodate these needs. Evaluating products for the full spectrum of PFASs requires a robust testing strategy with appropriate expert guidance.

4. Engage thoughtfully in public consultations

While there’s no guarantee of success, there can be great value in contributing to the consultation process surrounding new restrictions. With a six-month consultation on the new PFAS restriction proposal planned to start on 22 March 2023, time is of the essence. During the consultation on C9-14 PFCAs authorities took note of considered, evidenced feedback from stakeholders. Engaging in the early stages of the consultation process is critical when there is concern or uncertainty over the impact of legislation, as is likely under the upcoming PFAS restriction. History shows that providing well thought out, evidenced feedback during the consultation process can pay off.

For example, an international manufacturer of semiconductors requested a time-limited derogation so it could meet proposed concentration limits for C9-14 PFCAs in articles. The same organisation responded to the subsequent draft opinion consultation with further information on use and estimated volumes. ECHA’s Committee for Socio-economic Analysis (SEAC) Rapporteurs publicly acknowledged the input, noting appreciation of the additional detailed information, and agreeing to a proposed amendment to clarify the derogation. The final restriction terms adopted in August 2021 reflected this request.

5. Keep appraised

Outside the EU, further PFAS regulations in the pipeline will have a significant bearing on import, manufacture and use in global markets. The US and Canada already have their own restrictions in place for certain PFAS groups and categories, and more could follow. Great Britain (GB) is also considering broader PFAS restrictions under UK REACH. Stakeholders need to keep an eye on multiple channels, at international (e.g. Stockholm Convention), regional (e.g. EU REACH) and national, federal and local levels to keep on top of requirements.

Take an agile approach to emerging restrictions

Early preparations for emerging PFAS restrictions are possible despite a lack of specific information. Lessons from existing PFAS restrictions enables a proactive approach that can streamline and accelerate compliance. We advocate an agile and proactive mindset, working with available information and insights to manage risks effectively. Steps taken now can be adapted over time as further clarification is provided.

New PFAS restrictions will have significant repercussions for products across a wide range of sectors. It’s important to assess the impacts on supply chains then develop a carefully considered plan to mitigate and manage business risks. Meeting the requirements won’t always be feasible. However, there are opportunities to work with relevant authorities to shape more nuanced development of regulations. Experience shows that well-evidenced and reasoned arguments are most likely to succeed.

Support with PFAS

Our product stewardship services encompass a wide range of regulatory and scientific support for industrial and speciality chemicals. Find out more here and get in touch at [email protected] to arrange an informal chat with our team.

You can also read our Expert Opinion piece, published recently in Chemical Watch: What can industry learn from existing PFAS restrictions ahead of further EU regulation of the substance group?