The EU RoHS Directive (2011/65/EU) has been amended by Commission Delegated Directive (EU) 2023/1526. This amendment adds a new RoHS exemption – 41a.
Exemption 41a allows the use of “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 in whole blood.”
This new exemption applies to category 8 and expires on 31 December 2023.
The limited time frame for the exemption is due to the availability of a replacement to lead as a thermal stabilizer in PVC and due to new REACH restrictions of lead in articles produced from PVC polymers or copolymers that enters into force on the 29th of November, 2024.