Study to assess three exemption requests relating to Annex IV to Directive 2011/65/EU: request for amendment of existing exemption 31a; request for a new exemption for Bis-(ethylhexyl) phthalate (DEHP) in ion selective electrodes for point of care analysis of ionic substances in human body fluids; and request for a new exemption for DEHP in plastic strain relief devices used to prevent damage to cable connections to MRI imaging coils - Pack 17

Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS 2) provides that "electrical and electronic equipment placed on the market, including cables and spare parts for its repair, its reuse, updating of its functionalities or upgrading of its capacity, 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 to grant three exemptions from these restrictions relating to medical devices and monitoring and control instruments (Annex IV): a request for an amendmend of exemption 31a for spare parts removed from medical devices and reused for the repair or restoration of medical devices, DEHP in ion-selective electrodes for point-of-care analysis of ionic substances in human body fluids, DEHP in plastic strain relief devices used to prevent damage to cable connections to MRI imaging coils. The project consortium provided technical and scientific support for the evaluation of these three requests for exemption from the RoHS Directive. The applications were evaluated to determine whether they were 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 allowed in the respective applications in accordance with the mandate given to the Commission under the RoHS Directive.