Study to assess request for one (-1-) exemption, for lead as a thermal stabilizer in polyvinyl chloride (PVC) used as base material in amperometric, potentiometric and conductometric electrochemical sensors which are used in in-vitro diagnostic medical devices for the analysis of Creatinine and Blood Urea Nitrogen (BUN) in whole blood, in Annex IV of Directive 2011/65/EU (Pack 26)

Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS) states 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, does 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 an exemption from these restrictions, which relates to medical devices and monitoring and control instruments (Annex IV). Oeko-Institut provides technical and scientific support for the evaluation of this request for exemption from the RoHS Directive. The application will be subject to an evaluation to determine whether it is justified in the light of technical and scientific progress and, in particular, whether the use of a banned substance or a substance subject to restrictions is allowed in the application in accordance with the mandate given to the Commission in relation to the RoHS Directive.