EU RoHS exemptions on four phthalates in medical devices published

Edited on 02/03/2022
The European Commission has published directives on new exemptions of authorization for the use of DEHP, DBP, BBP and DIBP in medical devices under the EU RoHS Directive.
News text: 

Directive (EU) 2015/863, the RoHS Directive1, sets a maximum concentration of 0.1% for DEHP, DBP, BBP and DIBP in homogeneous materials in electrical and electronic devices.  However, delegated Directives were published in the Official Journal on 15 November adding the following exemptions for electrical and electronic parts of medical devices to Annex IV of the RoHS Directive:

- use of DEHP in plastic components of magnetic resonance imaging (MRI) detection coils (exemption granted until 01/01/2024)

- use of DEHP in ion-selective electrodes for human body fluid analysis and/or in dialysate fluids (exemption granted until 21/07/2028)

- use of DEHP, BBP, DBP and DIBP in spare parts recovered and used for the repair or refurbishment of medical devices (including in vitro diagnostic medical devices, and their accessories) (exemption granted until 21/07/2028)

EU Member States are required to adopt and publish the laws, regulations and administrative provisions necessary to comply with the Directives by 30 April 2022.

1 Restriction of Hazardous Substances in electrical and electronic equipment