• September 5, 2019
  • WTO

Exemption for lead as a thermal stabiliser in PVC used in certain in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases | Amendment of Annex IV to Directive 2011/65/EU


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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 lead as a thermal stabiliser in polyvinyl chloride used in certain in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases (7 pages + Annex 2 pages, in English)

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

Notifying member: European Union

NotificationG/TBT/N/EU/678

Objective tag
Other

Objective
Adaptation of existing legislation to scientific and technical progress, granting manufacturers adequate transition time for compliance.

Documents


Agency responsible
European Commission


Timing:

  • Submission: 04/09/2019
  • Reception: 04/09/2019
  • Distribution: 04/09/2019
  • Final date for comments: 03/11/2019
  • Proposed date of adoption: N/A

                   

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