Study to assess seven (7) exemption requests relating to Annex III and IV to Directive 2011/65/EU

Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS 2) states that "no electrical and electronic equipment placed on the market, including cables and spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity must contain any of the substances listed in Annex II (e.g. lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls and polybrominated diphenyl ethers)". The Commission has received requests to grant three exemptions from these restrictions relating to medical devices and monitoring and control instruments (Annex IV):

  • a request to amend the derogation 31a for spare parts recovered from and used for the repair or refurbishment of medical devices,
  • DEHP in ion-selective electrodes for point of care analysis of ionic substances in human body fluids,
  • DEHP in strain relief devices used to prevent damage to cable connections to MRI imaging coils.

The project consortium will provide technical and scientific support for the evaluation of these three requests for exemption from the RoHS Directive. The requests will be evaluated to determine whether they are justified in the light of technical and scientific progress and, in particular, whether the use of a prohibited substance or a substance subject to restrictions is allowed in the respective exemption requests in accordance with the mandate given to the Commission under the RoHS Directive.