MedTech Europe are collecting feedback on ECHA’s report advising the Commission that regulatory action is needed at EU level on PVC and its additives and responding to this EC proposal. The Annexes to the report are available at here.
BIVDA members are invited to review the report and share with us your findings. The MedTech Europe Secretariat have reviewed the report and found:
- Medical applications are estimated to account for 2% of the overall PVC uses (page 29)
- MedTech Europe’s input has been referenced throughout the report and in a dedicated section 4.2.9
- The correlation between the use of PVC and DEHP in medical applications is mentioned (pages 19 and 41)
- It is explained that certain legislation, including the Medical Devices Regulation, ‘do not address environmental risks as presented in this report, but only cover the exposure (by leaching/volatilization/migration) from the actual products during use, not over the lifecycle of the material’
- The report suggests regulatory measures to:
- Minimize risks from plasticizers and in particular ortho-phthalates (most likely via a REACH Restriction)
- Reduce the risks from the organotin substances (most likely via a REACH Restriction)
- Reduce PVC microparticle releases
- Address flame retardants, however, there is already a Strategy proposed by ECHA on this issue separately
Next steps
- Once MedTech Europe have collected members’ feedback, they will organize a call to discuss next steps based on members’ feedback and communicate what actions MedTech Europe can take on this file over the next months.
If this is going to impact your products, we kindly ask members to submit your feedback and supporting information to Regulatory@bivda.org.uk by 15 December.
