Our Japanese manufacturer, FluoroTechnology, has stated that their FG-5091TH series and FG-5040EX series comply with this regulation!
The European Commission announced in August this year the revision of Annex XVII of the REACH regulation, restricting substance No. 68, concerning "C9-C14 perfluorocarboxylic acids (PFCAs), their salts and related substances, perfluorononanoic acid (PFNA), perfluorodecanoic acid (PFDA), perfluoroundecanoic acid (PFUnDA), perfluorododecanoic acid (PFDoDA), perfluorotridecanoic acid (PFTrDA), perfluorotetradecanoic acid (PFTDA), including their salts and precursors" to specified concentration limits.
Starting from February 25, 2023, the total concentration of C9-C14 PFCAs and their salts must be below 25 ppb, and the total concentration of related substances of C9-C14 PFCA must be below 260 ppb. There are also exceptions, different effective dates, and concentration limits for various uses or products, including oil and water repellent textiles, filtration membranes, lithography or etching processes in semiconductor manufacturing, photographic coatings, invasive and implantable medical devices, and firefighting foams.
The European Commission's announcement states that C9-C14 perfluorocarboxylic acids (PFCAs), their salts, and related substances are by-products inadvertently produced during the manufacturing of perfluorinated and polyfluorinated substances with fewer than nine carbon atoms (including perfluorooctanoic acid, PFOA). These substances have various hazards; for example, PFNA and PFDA are reproductive toxicants and have been classified as persistent, bioaccumulative, and toxic (PBT) substances; the sodium and ammonium salts of both are listed in Annex VI, Part 3, Section 2 of EU Regulation (EC) No 1272/2008 as Category 2 carcinogens—suspected human carcinogens—and Category 1B reproductive toxicants—known human reproductive toxicants; PFUnDA, PFDoDA, PFTrDA, and PFTDA are characterized by very persistent and very bioaccumulative (vPvB) properties.
Although the EU had previously removed PFOA from Annex XVII and incorporated it into the Persistent Organic Pollutants (POPs) regulation for management, they have included the by-products C9-C14 PFCAs in the restrictions due to their considerable hazards inadvertently produced during the manufacturing process, to provide more comprehensive protection for human health and the environment.
Source: International Chemical Policy Promotion and Implementation Network of the Industry Development Bureau, Ministry of Economic Affairs Original URL: https://www.chemexp.org.tw/content/news/NewsDetail.aspx?id=4573
