BioPhorum response to the Annex XV report on the proposal for universal PFAS restrictions
PFAS compounds (mainly fluoropolymers PTFE, EFTE, PVDF, FKM, FEP, PFA) are used extensively across multiple industries including the biopharmaceutical industry due to their unique functional properties and low reactivity.
The European Union Chemicals Agency (ECHA) has put forward a proposal to restrict the use of per- and poly-fluoroalkyl substances (PFAS), commonly considered ‘forever chemicals'. If it passes, it will ban the production and import of a group of more than 10,000 persistent chemicals with implementation in 2026/27.
While BioPhorum appreciate the efforts being made to address concerns surrounding PFAS and share the commitment to protecting human health and the environment, the consensus of our group is that the proposal
does not consider the significant and wide-reaching impact of the proposed restrictions on the manufacture and supply of critical therapies. We believe that the biopharmaceutical industry should be considered a missing
use category and be exempt from all proposed restrictions where alternatives are not available; there needs to be a discussion around how to handle uses for which, despite huge efforts in R&D, no alternative can be found within the given transition time.
As an industry, we are dedicated to working collaboratively to ensure that any proposed restrictions consider the unique challenges and requirements of biopharmaceutical manufacturing while maintaining safety and environmental integrity. We wish to emphasise the importance of a science and risk-based approach to restrictions. It is crucial to consider the available scientific data, risk assessments, and expert opinions to ensure that the restrictions are proportionate and targeted towards substances that pose significant risks.
|BioPhorum response to the Annex XV report on the proposal for universal PFAS restrictions May 2023.pdf|
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