• July 4, 2021
  • WTO

EU | Draft Commission Delegated Directive amending Annex IV to Directive 2011/65/EU as regards an exemption for the use of DEHP, BBP, DBP and DIBP in spare parts of medical devices

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Title of document
Draft Commission Delegated Directive 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), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the repair or refurbishment of medical devices (7 page(s), in English; 2 page(s), in English)

This draft Commission Delegated Directive concerns an application to grant a new specific and temporary exemption from the Directive 2011/65/EU (RoHS 2) substance restrictions.

Notifying member: European Union


Objective tag
Protection of human health or safety; Protection of the environment

Adaptation of existing legislation to scientific and technical progress. The draft Commission Delegated Directive concerns a new exemption from substance restrictions due to apply from 22 July 2021. A shorter notification period is necessary to avoid potential negative impacts on medical facilities, which may be caused by a delay of granting the targeted exemption beyond the restrictions’ entry into force date.


Agency responsible
European Commission


  • Submission: 29/06/2021
  • Reception: 29/06/2021
  • Distribution: 29/06/2021
  • Final date for comments: 14/07/2021
  • Proposed date of adoption: N/A


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