DEHP plasticizer is registered for use under REACH Sri Lanka

  • DEHP plasticizer is registered for use under REACH Sri Lanka
  • DEHP plasticizer is registered for use under REACH Sri Lanka
  • DEHP plasticizer is registered for use under REACH Sri Lanka
  • Is DEHP registered for medical devices?
  • It has been registered for all current uses including medical devices. The registration enables the continued manufacturing and use of DEHP. However, because DEHP is classified in Europe as a Substance of Very High Concern (SVHC), its uses beyond January 2015 will eventually need to be authorised.
  • Is DEHP used as a food contact material?
  • DEHP is a substance for which the exemption for use in food contact materials within the scope of Regulation (EC) No 1935/2004 has been removed [for which it is used]. Applications for authorization must be submitted by 14.06.2023, and the ban on use under Art. 56 (1) REACH will take effect from 14.12.2024.
  • When can DEHP be used in medical devices?
  • Under the EU Medical Device Regulation, the continued use of DEHP in medical devices after 31 December 2027 for high-risk devices and 31 December 2028 for medium- and low-risk devices requires a justification according to the latest relevant scientific committee guidelines.
  • When will DEHP be banned in the EU?
  • Under the EU’s chemical regulation REACH, the use of DEHP in the remaining applications will have to be terminated by 14 December 2024, or in medical devices by 1 July 2030. The plasticiser industry has invested more than €6 billion in developing safe alternatives.
  • Can plasticisers replace DEHP in blood bags?
  • The plasticiser industry has invested more than €6 billion in developing safe alternatives. For medical applications, the European Pharmacopoeia lists since 2016 the following plasticisers as replacements for DEHP: DINCH, BTHC, TOTM (TETHM) and DEHT (DOTP/DEHTP). These plasticisers can replace DEHP in virtually all instances, also in blood bags.
  • What is DEHP (di-octyl phthalate)?
  • DEHP (CAS No [117-81-7]) is also known as di-octyl phthalate (DOP) and is used mainly for making PVC soft and pliable. It accounts for around 17% of all plasticiser usage in Western Europe and approximately one third of plasticiser use worldwide. It has been registered for all current uses including medical devices.

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