The European Chemicals Agency (ECHA) is proposing a REACH Restriction, or a ban on the manufacture, placing on the market, and use of per- and polyfluoroalkyl substances (PFAS) potentially as early as 2027. These so-called ‘forever chemicals’ are substances of concern, due to persistence in the environment. At least 10,000 substances including fluoropolymers fall within scope of the Restriction, making it the most complex ever proposed in the EU.
There are multiple applications of fluoropolymer containing plant, equipment, consumables in pharmaceutical manufacturing. For example, PFA (Perfluoroalkoxy alkanes) are chemically inert, stable and of very high purity which means they are used extensively in biomanufacturing processes. Other types of fluoropolymers provide corrosion protection against aggressive process solutions, for this reason extensive PTFE (polytetrafluoroethylene) lined pipework and components are found in chemical synthesis facilities. Pharmaceutical sector use of fluoropolymers in process installations, equipment and consumables is not listed nor evaluated in the proposed Restriction. During a six-month public consultation period, which opened on March 22nd stakeholders must engage and provide supporting evidence for derogations.
The briefing will give you an overview of the proposed REACH restriction regulatory process highlighting the critical urgency for the sector to mobilise to seek relief from the proposed ban on the use of fluoropolymers. This is a call for action, as EU manufacturing facilities would not be able to function without fluoropolymers and if these facilities are global suppliers of APIs (active pharmaceutical ingredients), supply chains of medicines will be put at risk.