Study to assess one (1) request for a new exemption to Annex IV of Directive 2011/65/EU for bis-(2-ethylhexyl) phthalate (DEHP) in plastic components in MRI detector coils

Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS 2) stipulates that "electrical and electronic equipment placed on the market, including cables and spare parts for repair, reuse, upgrading of functions or performance upgrading, shall not 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 for the extension of a derogation from these restrictions, which relates to medical devices and monitoring and control instruments (Annex IV). The project consortium provided technical and scientific support for the evaluation of this request for exemption from the RoHS Directive. The application was evaluated to determine whether it was 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 was permitted in the application in accordance with the mandate given to the Commission in relation to the RoHS Directive.