Statement on the European Chemicals Agency PFAS Restriction Proposal

No, polymeric substances are clearly toxicologically harmless. Our PTFE and FKM materials for applications in the pharmaceutical and food & beverage industries have been intensively tested and comply with all legal requirements.

It is impossible to make a general statement about the toxicity of PFAS, as this broad group contains 10,000 of different substances. Fluoropolymers like FKM or PTFE are defined by OECD as ‘polymers of low concern’ which have insignificant environmental and human health impacts.

In its 2020 chemicals strategy for sustainability, the European Union (EU) formulated a zero-pollutant target that aims to better protect citizens and the environment from harmful chemicals.

In mid-February 2023, the European Chemicals Agency ECHA published a proposal prepared by five EU member states to regulate the substance class of per- and polyfluoroalkyl substances (PFAS), which is intended to largely restrict the placing on the market, manufacture, use and import of PFAS.

The approximately 10,000 per- and polyfluorinated alkyl compounds (PFAS) affected by the forthcoming EU regulation can be divided into two groups: the low molecular weight per- and polyfluoroalkyl substances (small molecules) and the polymers (large molecules).

Polymers include, for example, thermoplastics such as PTFE, PVDF, FEP and rubbers FKM, FFKM and FVMQ. Freudenberg Sealing Technologies does not manufacture these itself but we use them - mainly PTFE and FKM - as base materials for some of our sealing materials.

The materials in question, such as PTFE and FKM, are high-performance materials: they have a long lifetime and a high temperature resistance; they are resistant to aggressive media and resistant to wear.

In very few cases will there be a 1:1 replacement with other suitable materials that meet these requirements. Reductions in e.g. the service life are to be expected.

Freudenberg Sealing Technologies has evaluated the affected parts on the basis of the information available from the restriction proposal and is in contact with customers regarding the affected part numbers. In this context, please note that affected part numbers may change depending on the wording of the final EU Commission's proposal to amend REACH Art. XVII.

The current restriction proposal does not evaluate on the PFAS concentration. Parts containing any concentration would be affected, which is why Freudenberg Sealing Technologies does not focus on assessing the concrete PFAS concentration of affected parts at the moment.

Although the evaluation of the restriction proposal is currently ongoing, Freudenberg Sealing Technologies has started to review alternative materials as part of its risk mitigation efforts. We have many high-performance materials in our portfolio that do not contain fluoropolymers. Due to our long-term experience and expertise in material development and testing, we are continuously evaluating application-based alternatives. We align on the specific options with each customer individually.

PFAS regulation is not only an EU-specific issue but will also have an impact on the global economy. Other jurisdictions around the world have also begun regulating, or are considering regulating, PFAS in products. In the US, individual states have begun restricting and requiring reporting on the use of intentionally added PFAS in all products (i.e., Maine and Minnesota) or for specific product groups. At the federal level, the US Environmental Protection Agency has finalized a rule under the Toxic Substances Control Act (TSCA) requiring reporting and recordkeeping for companies that manufactured or imported PFAS between 2011 and 2022, which includes companies that imported articles that contained PFAS in any amount during that period (the TSCA PFAS Reporting Rule, 40 Code of Federal Regulations Part 705). The regulation of PFAS-containing products is currently a very active area in which legislators and government agencies are developing laws and regulations at various levels.

TSCA provides EPA with the authority to require reporting, recordkeeping and testing requirements, and restrictions relating to chemical substances and mixtures. Certain substances are generally excluded from TSCA, including, among others, food, drugs, cosmetics, and pesticides.

In 2019, the US Congress amended TSCA to require EPA to adopt a PFAS reporting rule, which EPA finalized in October 2023. This TSCA PFAS Reporting Rule imposes a one-time reporting and recordkeeping requirement on companies that manufactured or imported PFAS at any time between 2011 and 2022, including companies that imported articles (e.g., finished goods or components) in that period that contained PFAS in any amount. The rule does not apply to other activities that may involve PFAS, such as domestic distribution, processing, and use. The reporting period for the TSCA PFAS Reporting Rule will not open until late 2024, and reports for most companies are due by May 8, 2025. As such, FST is currently evaluating the applicability of EPA’s new rule to our products, as we do for all other potentially relevant chemical laws and regulations.

Proposition 65 is a California law that requires companies to provide warnings to the public about exposure risks for certain chemicals in their products. Proposition 65 currently contains requirements for certain specific PFAS, including perfluorooctanoic acid (PFOA), perfluorooctanoic sulfonate (PFOS), and perfluorononanoic acid (PFNA). In contrast, the EU PFAS restriction proposal focuses on restricting PFAS as a broad chemical class (rather than simply requiring warnings for specific PFAS).

The US State of Maine’s PFAS law as currently enacted (38 Maine Revised Statutes Section 1614) requires companies that manufacture products containing intentionally added PFAS for sale in the state to report information on such products to the Maine Department of Environmental Protection (DEP) by January 1, 2025. The law also prohibits the sale, offer for sale, and distribution for sale in the state of any product containing intentionally added PFAS starting January 1, 2030, unless Maine DEP has determined that PFAS use to be a currently unavoidable use (CUU). The reporting obligation requires companies to submit information including a description of the product, the purpose of the PFAS in the product, the amount of each PFAS in the product, company contact information, and any additional information Maine DEP may require by rulemaking.

Maine DEP has indicated that it plans to initiate rulemakings later this year to implement the law. The agency also solicited proposals, due March 1, 2024, from industry on products that should be covered by CUU determinations. Moreover, the Maine legislature is considering potential amendments to the law, though no formal legislative amendment has been set forth yet. As with the TSCA PFAS Reporting Rule, FST is monitoring the evolving developments in Maine and is currently evaluating the applicability of the Maine law to our products.

The US State of Minnesota has enacted a PFAS in products law (Minnesota Statutes Section 116.943) that is similar in scope to Maine’s law, but with different compliance dates. Specifically, Minnesota’s law requires manufacturers to report to the Minnesota Pollution Control Agency (MPCA) on intentionally added PFAS in products by January 1, 2026, with reporting requirements that are similar to what is specified in Maine’s law. In addition, the Minnesota law restricts the sale, offer for sale, and distribution for sale of all products containing intentionally added PFAS starting January 1, 2032, unless the MPCA has determined the PFAS use to be a CUU (the law also has earlier restrictions for specific consumer products, such as cookware and cosmetics, that are not applicable to FST).

The MPCA has initiated the rulemaking process to implement the state’s PFAS in products law. Namely, the MPCA hosted a public comment period in late 2023 to inform future drafting of the agency’s PFAS reporting and PFAS reporting fees rules, and then hosted another public comment period ending on March 1, 2024 to inform future drafting of a CUU rule. The MPCA will later publish draft rules for public notice and comment, and then it plans to adopt final rules by 2026. As in Maine and for the TSCA PFAS Reporting Rule, FST is currently evaluating the applicability of this Minnesota law to our products.