PFAS Restriction in the EU: Pharma Deutschland and VDDI request Comprehensive Exemptions

Pharma Deutschland and the Association of the German Dental Industry (Verband der Deutschen Dental-Industrie e.V., VDDI) have revised their joint position paper on per- and polyfluoralkyl substances (PFAS). The reason for this is the restriction proposal that the national authorities of Denmark, Germany, the Netherlands, Norway and Sweden submitted to the European Chemicals Agency (ECHA) in January 2023 as part of the EU chemicals regulation REACH. The aim of the proposal is to minimise risks associated with the manufacture, marketing and use of PFAS, as these cannot be adequately controlled.

After a six-month consultation period, which ended in September 2023, ECHA received over 5,600 comments from more than 4,400 organisations, companies and individuals. ECHA's Risk Assessment Committee (RAC) and Socio-Economic Analysis Committee (SEAC) are currently preparing their statements based on this feedback. In October 2024, ECHA published an overview table on the current status of the assessment. This table is updated regularly. In November 2024, ECHA and the national authorities involved published a progress report.

The updated position paper from Pharma Deutschland and the VDDI highlights the impact of the restriction proposal on pharmaceutical and medical device manufacturers in detail. The associations are requesting a complete exemption for finished medicinal products, their APIs and excipients as well as for medical devices, including the entire manufacturing process. If this is not possible, they are in favour of an additional transitional period of ten years to the maximum envisaged period of 13.5 years, which would mean a total of 23.5 years to transition to PFAS-free alternatives. According to the associations, this period of time is essential to ensure the supply of vital medicinal products and medical devices to the population. You can read the full position paper and the annex to the position paper in the members' area of Pharma Deutschland.