In February 2023, the European Union Chemicals Agency (ECHA) proposed restricting the use of per- and poly-fluoroalkyl substances (PFAS). Commonly considered ‘forever chemicals’, PFAS are used extensively across multiple industries, including biopharma, due to their unique functional properties and low reactivity. If successful, it will ban the production and import of a group of more than 10,000 persistent chemicals with implementation in 2026/27.
Our response has been submitted to the ECHA and published in BioPhorum response to the Annex XV report on the proposal for universal PFAS restrictions.
BioPhorum response to the Annex XV report on the proposal for universal PFAS restrictions 348.21 KB 332 downloads
Our overall opinion is that unless the ECHA provides our highly regulated industry with appropriate exemptions or derogations to find, test, and validate alternatives, and execute a transition away from these materials, there will be a real threat to the global availability of critical vaccines and biotherapeutics.
We request that the ECHA Risk Assessment and Socio-Economic Committees recognize and consider these key issues:
- The extensive use of PFAS across the biopharma sector in medically critical applications
- Biopharma sector as a ‘missing use’ category (the sector is a critical user of PFAS materials but is not appropriately recognized or considered as a use category in the Annex XV report, this omission needs to be addressed)
- The impact on our industry of sourcing, testing, and validating PFAS alternatives
- The impact on approvals by regulatory authorities—increased risk of supply disruptions
- The categorization of fluoropolymers vs. PFAS
- Improved environmental stewardship and waste management vs. a wide-reaching ban
- A request for exemption or maximum derogation periods.
We acknowledge the concerns regarding the potential adverse effects of PFAS on human health and the environment, and fully support efforts to minimize and mitigate the presence of these and other potential substances of concern.
However, it is crucial to approach the proposal by carefully considering the impact on the manufacturing and the supply of critical, lifesaving vaccines and medicines – the development and production of which involve complex processes requiring adherence to stringent quality standards, regulatory compliance, and extensive testing. Any significant changes in our practices can have far-reaching consequences for patients, innovation, and the ability of our industry supply chains to respond, e.g., to future global pandemic threats.
In many cases, no suitable alternatives to currently used PFAS are available. There is also insufficient global capacity to validate alternatives or manage subsequent regulatory change submissions within the proposed implementation period and listed derogation periods.
We believe the biopharma industry should be considered a ‘missing use’ category and be exempt from all proposed restrictions where alternatives are unavailable. There should be a discussion around how to handle uses for which, despite huge R&D efforts, no alternative can be found within the given transition time.
Our industry is dedicated to working collaboratively to ensure that any proposed restrictions consider the unique challenges and requirements of biopharma manufacturing while maintaining safety and environmental integrity. It is crucial to consider the available scientific data, risk assessments, and expert opinions to ensure the restrictions are proportionate and targeted toward substances that pose significant risks.
For more information, download the paper here and contact Louisa Mitchell, Global Change Facilitator, at louisa.mitchell@biophorum.com
Abstract
The BioPhorum response to the Annex XV Report on the proposal for universal PFAS restrictions. It is considered by the BioPhorum collaboration that unless ECHA provide the biopharmaceutical manufacturing industry with appropriate exemptions or derogations to find, test and validate alternatives and execute a transition out of these materials (where alternatives are available), there will be a real threat to the global availability of critical vaccines and biotherapeutics.
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