If DEHP is a low phthalate of very high concern, shouldn’t it be banned in medical applications?

DEHP has been registered under the EU’s Chemicals Legislation REACH. It is classified as a Substance of Very High Concern (SVHC), therefore its uses are subject to Authorisation since 2015.

The use of DEHP in some medical applications is still in Europe, but upon an evaluation of possible alternatives, four new plasticisers have been added to the European Pharmacopoeia:

• DINCH (cyclohexane-1,2-dicarboxylic acid, diisononyl ester)
• BTHC (butyryl tri-n-hexyl citrate)
• TOTM (tris(2-ethylhexyl) trimellitate)
• DEHT (bis(2-ethylhexyl) terephthalate)

These plasticisers can be used for containers and tubing used in human blood and blood components and empty sterile containers of plasticised PVC for human blood and blood components. In addition, these plasticisers are used for the manufacture of tubes in sets for transfusion of blood and blood components. [They are also used in the manufacture of plasticised poly(vinyl chloride) tubes for sterile containers for human blood containing anticoagulant solution..

[1] Commission Regulation (EU) 2023/2482 of 13 November 2023 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. Link