The RoHS Directive(2011/65/EU) outlines the restrictions on the use of certain hazardous substances in electrical and electronic equipment and includes a list of substances that are restricted. These compounds include lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBBs), and polybrominated diphenyl ethers (PBDEs).

The European Commission released a RoHS amendment on July 24, 2023, to incorporate a new exemption under Annex IV. A validity period has been granted to an EU RoHS exemption application for the lead as a thermal stabilizer in polyvinyl chloride (PVC) used as the primary material in sensors used in in vitro diagnostic medical equipment. The Commission found that lead replacement in specific sensors is incomplete. As a result, the exemption is only valid for a short time.

The modification was effective from August 13, 2023. The EC also issued a corrigendum2 detailing the deadlines by which Member States must approve and implement this Directive.

In Annex IV to Directive 2011/65/EU, the following entry 41a was added:

The process for adding a new substance to the RoHS (Restriction of Hazardous Substances) involves several steps and considerations. The goal is to ensure that any exemptions granted are based on valid reasons and are consistent with the overall objectives of the RoHS Directive to protect human health and the environment.


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