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The European Commission has published Delegated Directive (EU) 2023/1526 amending the RoHS Directive.
Exemption 41a exempts 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.
The exemption expires on 31 December 2023.
The limited availability of the exemption reflects the following expectations:
Companies are advised to have a plan in place to minimise the use of lead due to health concerns.