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) Article 4(1) of 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 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) On 1 December 2021, 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 lead as a thermal stabilizer in polyvinyl chloride used as base material in sensors used in in vitro diagnostic medical devices (‘the requested exemption’). (5) The in vitro diagnostic medical devices described in the requested exemption fall under category 8 ‘medical devices’ of Annex I to Directive 2011/65/EU. (6) A technical and scientific assessment study (2) was carried out to evaluate the requested exemption. The evaluation included stakeholder consultations as required by 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 requested exemption concluded that the substitution of lead in specific sensors is not completed yet. The availability of substitutes for such specific devices is not ensured as current lead substitutions are not reliable for all parameters (for example, creatinine and blood urea nitrogen) or have a low accuracy for such parameters. In addition, the evaluation concluded that rejecting the requested exemption would negatively affect the health service. (8) The requested exemption thus meets at least one of the relevant conditions specified in Article 5(1), point (a), of Directive 2011/65/EU as the reliability of substitutes for the specific application subject to the exemption request is not ensured. Also, the overall negative environmental, health and consumer safety impacts and the socioeconomic impacts of not granting an exemption are being taken into account. (9) The requested exemption is consistent with Regulation (EC) No 1907/2006 of the European Parliament and of the Council (3) and thus does not weaken the environmental and health protection afforded by that Regulation. (10) It is, therefore, appropriate to grant the requested exemption by including the relevant application in Annex IV to Directive 2011/65/EU with respect to electrical and electronic equipment of category 8. (11) In light of the expected availability of substitution of lead in the application subject to the exemption and of possible future restrictions on lead in polyvinyl chloride in Regulation (EC) No 1907/2006, it is necessary to grant the exemption for a limited validity period until 31 December 2023. That validity period is set in accordance with Article 5(2), first subparagraph, of Directive 2011/65/EU. (12) 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.