Germany has recently proposed a restriction on Perfluorohexanoic Acid (PFHxA) and related substances. Substances that fall within the scope of the restriction are used in various applications, such as textiles and firefighting foams.
Our focus is on the use of PFHxAs and PFHxA related substances in the production of various fluoroelastomers such as FKM, FFKM, and FEPM solid polymers. These polymers can be molded in o-rings, seals and gaskets. Because of their superior chemical and high-temperature resistance, these rubber seals are used in:
- Automotive engines
- Semiconductor processing
- Medical instrumentation
- Water purification
If the current restriction proposal goes through, the ability to continue the manufacture of fluoroelastomers in the EU would be severely impacted, thus causing supply disruptions globally.
The basis for the PFHxA restriction centers around the concern that PFHxA is persistent and mobile in aquatic environments, including groundwater. Additionally, PFHxA is difficult to remove from wastewater, drinking water and contaminated sites. However, PFHxA is not toxic as defined by CLP regulations and not bioaccumulative.
These criteria for the PFHxA restriction have not been solely used in other previously restricted substances and do not demonstrate “unacceptable risk” as required by Article 68 of REACH. The use of these criteria alone could set a new precedent for the future.
If the restriction is not rejected or withdrawn, exceptions should be given to fluoropolymers and fluoroelastomers. Proposed restrictions were submitted by the Chemours Company, and they include:
- Import, manufacturing, placing on the market (incl. export) and use of Fluoropolymers, Fluoroelastomers, and Perfluoropolyether Polymers that potentially contain PFHxA and PFHxA-related substances as trace level impurities without a threshold level and without a time limit
- The manufacture, import, and use of PFHxA, its salts, and PFHxA-related substances to be used as polymerization processing aids (PPAs) for the production of fluoropolymers, such as PTFE and fluoroelastomers, in the EU should be exempted without a time limit. Currently, high-performance fluoropolymers and fluoroelastomers can only be produced when utilizing fluorinated PPAs
This effects fluoroelastomer use across a wide range of industries, including:
- Automotive: Gaskets seals for fuel assemblies, o-ring for emission controls, under-hood gaskets
- Renewable Energy: Coolant seals for air cools in wind turbines, gaskets in hydrogen fuel cells packs
- Food and Pharmaceuticals: Sanitary gaskets seal for tube connectors, labware products, valve seals
- 化学和阿宝wer: Vessel housing gaskets, sensor seals, fluid-handling components
- Medical:Medical device seals, pump U-cups, housing gaskets, o-rings
You can find thefull version of the proposed restriction here. At the present time, comments have been closed, but there will be another chance to submit industry concerts. If this will affect your business, comments should be submitted to prevent challenges down the line. Monitor for yourcomment submission here.