Regulations – What’s all the PFAS about?

Regulations – What’s all the PFAS about?

Regulations – What’s all the PFAS about?

Thu 13, 07 2023

Nigel Burtt, IABM Technology Specialist

Twenty-three years ago, in June 2000, the European Commission published proposals for their WEEE and RoHS Directives and three years later they were agreed and entered into force, having a major impact on all industries. The RoHS Directive originally restricted six substances and effectively banned the use of lead, mercury, cadmium, hexavalent chromium and two types of flame retardants in most new electrical and electronic equipment sold after 1 July 2006. This had a major impact on our industry mainly due to the need to use lead-free solder in the manufacture of electronic equipment. The Directive has been amended several times since and, as of 2015, now there are ten substances that RoHS restricts along with the equivalent UK post-Brexit law that replaces it. Very similar laws and regulations now also exist for other countries and their markets, such as Japan, South Korea, China, and India.

Alongside the RoHS Directive, there is Europe’s REACH regulation for the control of chemicals which came into force in 2007. This maintains a  ‘Candidate List’ of Substances of Very High Concern (SVHC} that may be subject to future restriction within the European Union and, at the time of writing, includes 233 different entries. From the original list, 59 of these already now are restricted, each with a final ‘sunset date’ and need special authorisation for any usage beyond that date. With updates made to the REACH lists every six months, this presents a difficult moving target to manufacturers and distributors who sell products in Europe with a continual re-assessment needed of the substances used in their manufacturing processes and within the components of those products.

This situation will soon become even more difficult with restrictions being proposed on substances known as Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS.) PFAS are sometimes called “forever chemicals” because they do not naturally breakdown in the environment, so there is wide concern over the longevity of their polluting potential.

Some types of PFAS are already restricted by global and national laws and regulations, but the total number of different PFAS that are likely to become restricted is huge. The global Organisation for Economic Co-operation and Development (OECD) maintains a free MS-Excel database of PFAS which already includes nearly 5000 different entries, but a new European Union proposal, published in February this year for future control of all PFAS usage within the EU under the REACH regulation, suggests as many as 10000 types will be affected. Hence, the complexity of managing electrical and electronic equipment (EEE) supplier obligations relating to controlled substances for reporting their usage of and removing them from the supply chain will likely increase by around an order of magnitude in the very near future.

As with RoHS, there are post-Brexit UK regulations that mirror the EU REACH rules, so the UK government has also been consulting stakeholders about its own possible response to PFAS usage and very recently published a report from the Health & Safety Executive (HSE) into the regulatory management options it may consider as part of the wider post-Brexit UK version of REACH. That said, the UK government is currently somewhat mired in its efforts to repeal EU legislation, such as REACH, for the completion of Brexit and the ‘Retained EU Law (Revocation and Reform) Bill’ (REUL) is not progressing as fast as it had hoped.

And it’s not just the EU and UK that are considering restrictions on PFAS – the HSE report referred to above identifies actions proposed or already being taken by the USA, Canada, Australia, Japan, and China. In the USA, the Environmental Protection Agency (EPA) has already taken action and there are proposals in play to go further. Various States already have rules in place without yet applying these to EEE product. However, most recently, at the beginning of 2023 the State of Maine introduced a law that includes a requirement to report any product sold, offered for sale, or distributed for sale in Maine which contains intentionally added PFAS. This requirement is for ‘…all products and product components sold in Maine for personal, residential, commercial, or industrial use are subject to this program. If a product is offered for sale in Maine for one of those purposes, the Manufacturer of the product must report the amount of PFAS in their product.

The likelihood of these restrictions is already moving chemical suppliers to phase out PFAS and, where possible, to offer PFAS-free alternatives. For example, 3M have a dedicated website for PFAS and have announced that they will stop manufacturing substances containing PFAS, and remove any products affected from sale, by the end of 2025.

The problem of restriction and removal from the market of PFAS is the wide number of end-use applications across many industries. The Royal Society of Chemistry published a paper in 2020, ‘An overview of the uses of per- and polyfluoroalkyl substances (PFAS)’, which summarises many of the main applications in the Appendix, and this highlights several which are vital to EEE manufacturers, for example:

fluxing agents in solder pastes;

printed circuit board (PCB) layer construction;

lithium batteries;

cable and wire insulation;

capacitor dielectric materials;

liquid crystal displays (LCD);

process chemistry for semiconductor device manufacturing;

flame retardants in plastic materials.

So, how do we prepare to meet these challenges to our business? Consultancy organisation RINA reminds us that many PFAS exist in mixtures and are not yet classified as hazardous by the Global Harmonised System (GHS) so are not covered by national Classification, Labelling and Packaging (CLP) laws that implement this and as such they may well not appear on Material Safety Data Sheets that we rely upon to identify problematic substances. RINA recommend the following actions:

  • Contact all your material and component part suppliers and ask them to identify any items in your supply chain which are known to contain PFAS;
  • Identify all uses of PFAS in your manufacturing process and in component items within your products and start a programme for qualifying suitable alternatives wherever possible;
  • If you identify any PFAS usage that will still be required beyond 2026, engage directly, or via your trade association, with the European Chemicals Agency (ECHA) and prepare detailed information on the usage, risks, existing and future proposed control measures and the availability of, or lack thereof, suitable substitutes.
  • Submit detailed socio-economic reasons for PFAS usage before September 2023 to the ECHA consultation process to request a possible future exemption or derogation.
  • Review and respond to ECHA’s Risk Assessment Committee (RAC) and Socio-Economic Analysis Committee (SEAC) when they publish their response to the consultation process, which would be expected in Summer 2024.

Some industry trade bodies are already encouraging their membership to engage, for example IPC have published an ‘Urgent Call for Action’, suggesting collaboration across the industry and its supply chain partners to understand what information on PFAS usage can reasonably be provided to the ECHA consultation before the September consultation process deadline. If this is something you would also like IABM to organise, please let us know as soon as possible. IPC do make an important point that if your usage of PFAS amounts to business confidential information in some respects, you may not want to disclose this to a collaborative forum and you should submit the required information directly to ECHA yourself.

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