CE Union européenne
  • 11 - Technologies de la santé

medical devices

Draft Commission Regulation amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards the substance bis(2-ethylhexyl) phthalate (DEHP) in medical devices; (4 page(s), in English), (2 page(s), in English)

Commission Regulation (EU) 2021/2045 of 23 November 2021 (notified under G/TBT/N/EU/760) amended Annex XIV to Regulation (EC) No 1907/2006 (REACH) by giving a Latest application date (LAD) regarding uses of Bis(2-ethylhexyl) phthalate (DEHP) in medical devices until 27 November 2023 and a Sunset date (SD) until 27 May 2025.

The draft Commission Regulation will extend the LAD for uses of bis(2-ethylhexyl) phthalate (DEHP) in medical devices until 1 January 2029 and the SD until 1 July 2030. The draft Commission Regulation only extends the LAD and SD and does not contain any new requirements.