COMMISSION DELEGATED DIRECTIVE (EU) .../… of 11.8.2021 amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for the use of bis(2-ethylhexyl) phthalate (DEHP) in ion-selective electrodes for analysing human body fluids and/or dialysate fluids

Following an application for this exemption, the EU launched a technical and scientific assessment which included a consultation. The assessment concluded that current alternatives were not performing well and may have adverse socio- economic impacts. Not granting the exemption would result in early obsolescence of around 500 tonnes of equipment. Not to grant the exemption could place high financial and organisational burdens on healthcare facilities as a result of replacing the equipment. This could delay or prevent analyses and health services may have to finance unplanned new equipment resulting in unintended and indirect health impacts. Overall, the total negative environmental and health impacts are likely to outweigh the benefits if the exemption was not granted.

Topic  Agriculture 
Department  DEFRA 
Council Reference   
COM Reference   
SEC Reference   
PE Cons   
JOIN   
SWD   
C Reference  C(21)5868 

Associated file(s)


  1. C(2021)5868 - 261 KB - pdf
  2. C(2021)5868 + Add 1 - 122 KB - pdf
  3. EM C(2021)5868 - 147 KB - pdf

Search by reference numbers or topic