CONSUMER PRODUCTS AND RETAIL E-SSENTIALS

EU: A new RoHS exemption for Lead in PVC used in in-vitro Diagnostic Medical Devices is added to Annex IV

AUGUST 2023 - ELECTRICAL AND ELECTRONICS

On 24 July 2023, the European Commission published a RoHS amendment¹ to include a new exemption under Annex IV. An EU RoHS exemption application for lead as a thermal stabilizer in polyvinyl chloride (PVC) used as the base material in sensors used in in vitro diagnostic medical devices has been granted with a validity period. The Commission concluded that the substitution of lead in specific sensors is not completed yet. Hence, the exemption is granted for a limited period of time. Details of the exemption are listed in Table A. 

The amendment shall enter into force on 13 Aug 2023. The EC also published a corrigendum² to mention the dates when Member States shall adopt and apply this Directive. 

Table A. Newly added entry 41a in Annex IV

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