EU - New Proposed RoHS Exemption for Use of Lead in Specific Medical Devices

​The European Commission received an application on March 25, 2019 for an exemption to be listed in Annex IV to RoHS 2 Directive, for the use of lead in bismuth strontium calcium copper oxide (BSCCO) superconductor for use in cables and wires and lead in related electrical connections to other electrical and electronic equipment components. Lead-doped BSCCO can be used to create superconducting magnetic circuits for medical devices and monitoring and control instruments.

After the public consultation and a technical and scientific assessment study, it concluded that the additional of lead to BSCCO provides technical and functional advantages that cannot be achieved without the use of lead. Those technical and functional advantages consist in higher resolution images for medical diagnosis or for research and innovation, and allow a more stable operation mode of the relevant applications. The addition of lead to BSCCO makes it possible to produce more efficient and reliable equipment, which is beneficial for health care and innovation.

It is current not possible to subtitute or eliminate lead in the superconducting material and the related solders with the same technical performance, nor is it expected to be so in the foreseeable future.

Therefore, a new exemption entry 48 is proposed to be added to Annex IV to RoHS 2 Directive:

"Lead in bismuth strontium calcium copper oxide (BSCCO) superconductor cables and wires and lead in their electrical connections to these wires

Expires on June 30, 2027"

This draft act is open for feedback for 4 weeks until February 9, 2022