Stakeholders are being encouraged to weigh in on the European Chemicals Agency (ECHA) 60-day public consultation period related to a planned ban on per-and-polyfluoroalkyl (PFAS) substances, also known as forever chemicals.
The widely used substances are sometimes used in the production of pharmaceuticals, including being found in some active pharmaceutical ingredients (APIs), raw materials used for chemical synthesis, as well as in reagents and manufacturing equipment.
ECHA is accepting public comment from 26 March-25 May on a recent draft opinion by its Socio-Economic Analysis Committee (SEAC) about the feasibility, benefits and costs of proposed EU-wide Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) restrictions on PFAS..
As part of the process for getting a REACH restriction on a substance that harms human health or the environment, authorities in EU member countries explain the background and risks in a dossier, which is then reviewed by the SEAC and RAC. Both committees recommended a ban on PFAS across the EU, allowing for targeted derogations.
In its final opinion, published 10 March, the RAC noted the growing and highly persistent health risks of PFAS, including cancer and reproductive harm. It called for EU-wide regulatory action to protect people and the environment as well as risk management requirements if derogations for specific uses are allowed, including emissions monitoring and reporting of PFAS emissions from manufacturing and industrial sites.
The restrictions can also apply to packaging materials using fluoropolymers, or combination products such as pre-filled syringes.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) said that it was “deeply concerned” about the ECHA opinions in a 26 March statement. It will take time to find alternatives to PFAS and the pharma industry needs a time-unlimited derogation, in EFPIA’s view.
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