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 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) By Delegated Directive 2014/7/EU (2), the Commission granted an exemption for the use of lead in solders, termination coatings of electrical and electronic components and printed circuit boards, connections of electrical wires, shields and enclosed connectors that are used in certain medical magnetic resonance imaging (MRI) equipment (‘the exemption’), by including those applications in Annex IV to Directive 2011/65/EU. The exemption was to expire on 30 June 2020. (5) On 12 December 2018, the Commission received an application for renewal of the exemption (‘the renewal request’) that is within the time limit laid down in Article 5(5) of Directive 2011/65/EU. In accordance with that provision, the exemption remains valid until a decision on the renewal request has been adopted. (6) The evaluation of the renewal request 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. (7) The evaluation of the renewal request, which included a technical and scientific assessment study (3), concluded that old design MRI devices depend on lead-containing MRI components and are highly limited in their compatibility with new lead-free MRI components. That evaluation further concluded that lead-free models of non-integrated MRI coils are already available. However, as concerns MRI devices with integrated coils, the technical development and the approval procedure to develop lead-free solutions require additional time. (8) The use of lead in newly designed non-integrated MRI coils and in upcoming lead-free MRI devices with integrated coils should be excluded from the exemption with specific dates. (9) Not granting the renewal request could result in premature wastage of MRI devices due to a lack of compatible components or redesigning options. This could result in a supply gap of MRI equipment, which could in turn adversely affect health care for patients. (10) The total negative environmental, health and consumer safety impacts of substitution are likely to outweigh the total environmental, health and consumer safety benefits thereof. The exemption is consistent with Regulation (EC) No 1907/2006 of the European Parliament and of the Council (4) and thus does not weaken the environmental and health protection afforded by it. (11) It is, therefore, appropriate to grant the renewal of the exemption. (12) In order to provide compatible MRI equipment for health services and to allow time for the development of lead-free alternatives, it is appropriate to grant the renewal of the exemption, with a revised scope, for the maximum duration of 7 years until 30 June 2027, in accordance with Article 5(2), first subparagraph, of Directive 2011/65/EU. In view of the results of the ongoing efforts to find a reliable substitution, the duration of the exemption is unlikely to have adverse impacts on innovation. (13) 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.