Preamble

THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (1), and in particular Article 5(1), point (a), thereof, Whereas: (1) Directive 2011/65/EU requires Member States to ensure that electrical and electronic equipment placed on the market does not contain the hazardous substances listed in Annex II to that Directive. That restriction does not apply to certain exempted applications, which are specific to medical devices and monitoring and control instruments, and are listed in Annex IV to that Directive. (2) The categories of electrical and electronic equipment (EEE) to which Directive 2011/65/EU applies are listed in Annex I to that Directive. (3) Lead is a restricted substance listed in Annex II to Directive 2011/65/EU. (4) On 25 March 2019, the Commission received an application made in accordance with Article 5(3) of Directive 2011/65/EU for an exemption to be listed in Annex IV to that Directive, for the use of lead in bismuth strontium calcium copper oxide superconductor for use in cables and wires and lead in related electrical connections to other EEE components (‘the requested exemption’). Lead-doped BSCCO can be used to create superconducting magnetic circuits for medical devices and monitoring and control instruments. (5) The evaluation of the requested exemption included stakeholder consultations in accordance with Article 5(7) of Directive 2011/65/EU. The comments received during those consultations were made publicly available on a dedicated website. (6) Lead-containing solders are used to connect the superconducting wires and cables to other EEE components. There is currently no lead-free alternative available on the market that would provide a sufficient level of reliability for applications, where properties such as ductility and low electrical resistivity at low temperatures are required. (7) The evaluation of the requested exemption, which included a technical and scientific assessment study (2), concluded that the addition of lead to BSCCO provides technical and functional advantages that cannot be achieved without the use of lead. Those technical and functional advantages consist in higher resolution images for medical diagnosis or for research and innovation, and allow a more stable operation mode of the relevant applications. The addition of lead to BSCCO makes it possible to produce more efficient and reliable equipment, which is beneficial for health care and innovation. (8) It is currently not possible to substitute or otherwise eliminate lead in the superconducting material and the related solders with the same technical performance, nor is it expected to be so in the foreseeable future. The requested exemption is consistent with Regulation (EC) No 1907/2006 of the European Parliament and of the Council (3) and does not weaken the environmental and health protection afforded by it. (9) It is, therefore, appropriate to grant the requested exemption. (10) The technical advantages of the lead-doped BSCCO-material have the potential to promote improvements and innovation in medical diagnostics and in research. The duration of the exemption is unlikely to have adverse impacts on innovation. Therefore, it is appropriate to grant the exemption for an extensive validity period, in accordance with Article 5(2), first subparagraph, of Directive 2011/65/EU. (11) Directive 2011/65/EU should therefore be amended accordingly, HAS ADOPTED THIS DIRECTIVE:

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Source: EUR-Lex (Cellar) · retrieved 2026-10-17 · Text as adopted (Official Journal); later amendments are not incorporated in this text.