EU | Draft Commission Delegated Directive amending Annex IV to Directive 2011/65/EU as regards an exemption for the use of DEHP in ion-selective electrodes for analysing human body fluids and/or in dialysate fluids

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) in ion-selective electrodes for analysing human body fluids and/or in dialysate fluids (7 page(s), in English; 2 page(s), in English)

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

Notifying member: European Union

Notification: G/TBT/N/EU/809

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

Objective
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.

Documents

• 21_4400_01_e.pdf
• 21_4400_00_e.pdf

Agency responsible
European Commission

Timing:

• 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