The Life Science Manufacturers Association (LSMA) has joined numerous industry partners in formally communicating our serious concerns regarding the proposed universal PFAS restriction. You can read the full, co-signed industry letter here.
Our specific position is as follows: The Life Science Manufacturers Association (LSMA) fully supports the EU’s environmental objectives, but there are serious concerns that the proposed universal PFAS restriction risks significant, unintended socio-economic costs to society and jeopardises the global security of supply for critical healthcare products.
- Our position is that the European Commission must urgently define the remit and treatment of life sciences, bioprocessing, and biopharmaceutical sectors, seeking the most proportionate approach to address risks. This includes granting specific use exemptions for critical applications in the Life Science sector.
- Furthermore, the Commission must engage with industry to determine appropriate horizontal control measures (e.g., PFAS and waste management plans) and, crucially, define a clear process now for assessing and granting extensions where alternatives are unavailable (even after 13.5 years), acknowledging the lengthy R&D, revalidation, and regulatory approval requirements unique to our highly regulated customer base.
- Ultimately, a proportional, targeted approach that protects SR&D, essential uses, and small-volume applications is vital to safeguard innovation, new therapeutic development, patient access to medicines, and wider LS applications.
LSMA is continuing to assess and monitor the impact of the evolving PFAS restriction through member engagements and scheduled meetings with critical stakeholders.
