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EU RoHS Annex IV Adds an Exemption for Lead Release Time:2023-07-28

On July 24, 2023, the European Union issued Directive (EU) 2023/1526 in its Official Journal (OJ) to amend the RoHS Directive and add an exemption clause on lead in Annex IV. RoHS Annex IV is an exemption for medical devices and monitoring and control instruments applications. This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. The relevant contents of the new exemption clause are as follows:

In Annex IV to Directive RoHS, the following entry 41a is added:



Scope and dates of applicability


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.

Applies to category 8(Medical devices) and expires on 31 December 2023.

General principles for exemption clauses

Before the expiry of the exemption clause, enterprises or industrial organizations can apply to the European Commission for extending the validity of the exemption (18 months in advance). The European Commission shall evaluate the extension application received and decide whether to extend the exemption clause.

If no relevant party applies for extension, it will automatically expire upon expiration.

If enterprises or industrial organizations apply for extension, these exemptions will continue to be valid until the evaluation results are published. If the official approves the extension application, the official will give a new period of validity; If the exemption is revoked after the assessment, 12 to 18 months will be set for the transition of industry replacement materials.

It should be noted that the exemption is not always valid. Each clause of RoHS exemption has a corresponding period of validity. Enterprises should pay attention to the latest developments of RoHS exemption in real time, and pay attention to the replacement of expired exemption materials in products.

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