European Union | Draft Commission Delegated Directive amending Directive 2011/65/EU (RoHS) regards an exemption for lead as a thermal stabilizer in PVC used as base material in sensors used in in-vitro diagnostic medical devices

Title of document
Draft Commission Delegated Directive amending Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as a thermal stabilizer in polyvinyl chloride used as base material in sensors used in in-vitro diagnostic medical devices (7 pages, in English), (Annex - 2 pages, in English)

Description
This draft Commission Delegated Directive concerns applications for a specific and temporary exemption from the RoHS 2 (Directive 2011/65/EU) substance restrictions. The criteria for a new exemption are met and it is proposed to grant a time-limited exemption in Annex IV of that Directive. 

Notifying member: European Union

Notification: G/TBT/N/EU/946

Objective tag
Protection of human health or safety (TBT); Protection of the environment (TBT)

Documents

• 23_0440_01_e.pdf
• 23_0440_00_e.pdf

Timing:

• Submission: N/A
• Reception: N/A
• Distribution: 16/01/2023
• Final date for comments: N/A
• Proposed date of adoption: N/A