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News > EU RoHS Directives and Regulations > EU announces new RoHS Annex IV exclusion clauses 27 and 48

EU announces new RoHS Annex IV exclusion clauses 27 and 48

  • 2025-07-14

The Official Journal of the European Union officially published Commission Delegated Directives (EU) 2022/1631 and (EU) 2022/1632 on September 22, 2022, adding and revising the exclusion clauses in Annex IV of the RoHS Directive (2011/65/EU), mainly exempting lead in some medical devices.

歐盟官方公報在2022/9/22 正式發布Commission Delegated Directive (EU) 2022/1631 及(EU) 2022/1632,新增及修訂 RoHS指令(2011/65/EU) 附錄IV之排外條款,主要在部分醫療設備上鉛的豁免。

On September 22, 2022, the EU Official Journal officially published Commission Delegated Directive (EU) 2022/1631 and (EU) 2022/1632, adding Annex IV 27 (c) and (d) and 48 exclusion clauses to the RoHS Directive (2011/65/EU). This update will take effect 20 days after the announcement. EU member states should adjust the relevant laws and announce them before February 28, 2023, and officially implement them on March 1, 2023.
The changes are as follows:

ExemptionsApplication scope and date
27(c) Magnetic resonance imaging equipment for which the declaration of conformity for this model is first issued before September 23, 2022 (MRI) without an integrated receiving coil, or (d) magnetic resonance imaging (MRI) equipment with an integrated receiving coil, the magnets used in the equipment producing a magnetic field within a radius of 1 m from the isocenter. Initial declaration of conformity issued before 30 June 2024. Lead is used in: - solders, - terminal coatings for electrical and electronic components and printed circuit boards, - wire connections, shielding and enclosed connectorsExpiration date
June 30, 2027
48Lead in bismuth strontium calcium copper oxide (BSCCO) superconductor cables and wires and in electrical connections to these wiresExpiration date
June 30, 2027

Sources:(EU) 2022/ 1631, (EU) 2022/1632 (Please refer to the original text for details)

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