EU - Draft Regulation to Extend the Uses of Bis(2-ethylhexyl) phthalate (DEHP) in Medical Devices
European Commission notified a draft commission regulation to WTO on May 4, 2023.
The objective of this draft Regulation is to align it with the new deadlines introduced by Regulation (EU) 2023/607 of the European Parliament and of the Council of March 15, 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
The draft Commission Regulation will extend the Latest application date(LAD) for uses of bis(2-ethylhexyl) phthalate (DEHP) in medical devices until January 1, 2029 and the Sunset Date(SD) until July 1, 2030. The draft Commission Regulation only extends the LAD and SD and does not contain any new requirements
Source Link:
G/TBT/N/EU/977