European Commission amends EU RoHS to add new Annex IV exemptions

December 14, 2021Written by GreenSoft Technology, Inc.

3 New Exemptions Added To EU RoHS Annex IV List

eu-rohsOn November 15, the European Commission published an amendment to Annex IV of the EU RoHS Directive, which added 3 new phthalates exemptions.

Annex IV lists exemptions which specifically apply to medical devices and monitoring and control instruments.

The exemptions were entered into force as a matter of urgency and took effect retroactively on July 21, 2021.

The three new added exemption amendments are:

Exemption No. Exemption Description Expiry Date Link
45 Bis(2-ethylhexyl) phthalate (DEHP) in ion-selective electrodes applied in point of care analysis of ionic substances present in human body fluids and/or in dialysate fluids 21 July 2028 Link
46 Bis(2-ethylhexyl) phthalate (DEHP) in plastic components in MRI detector coils. 1 January 2024 Link
47 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, including in vitro diagnostic medical devices, and their accessories, provided that the reuse takes place in auditable closed-loop business-to-business return systems and that each reuse of parts is notified to the customer. 21 July 2028 Link

Updated EU RoHS Exemptions List available to download

GreenSoft maintains a compiled list of the EU RoHS Exemptions in order to perform EU RoHS Data Services for our customers and to keep our GreenData Manager software up-to-date. We also make this list available online to the public for your convenience and reference.

Our compiled EU RoHS Exemptions List has been updated to include these three new exemption amendments. You can download the updated EU RoHS Exemptions List here.

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