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) and (b), 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 III 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. The maximum tolerated concentration value is 0,1 % by weight of lead in homogenous materials. (4) Commission Delegated Directive (EU) 2018/739 (2) granted an exemption for the use of lead as an alloying element in steel for machining purposes containing up to 0,35 % lead by weight and in batch hot dip galvanised steel components containing up to 0,2 % lead by weight, as set out in point 6(a)-I of Annex III to Directive 2011/65/EU. That exemption covers categories 1 to 7 and category 10 of electrical and electronic equipment, listed in Annex I to Directive 2011/65/EU. The application of the exemption set out in point 6(a) of Annex III to that Directive was limited to electrical and electronic equipment categories 8, 9 and 11. (5) Commission Delegated Directive (EU) 2018/740 (3) granted exemptions for the use of lead as an alloying element in aluminium containing up to 0,4 % lead by weight either for machining purposes or for recycling of lead-bearing aluminium scrap. The exemptions are set out in points 6(b)-I and 6(b)-II of Annex III to Directive 2011/65/EU. Those exemptions cover categories 1 to 7 and category 10 of electrical and electronic equipment, listed in Annex I to Directive 2011/65/EU. The application of the exemption set out in point 6(b) of Annex III to that Directive was limited to electrical and electronic equipment categories 8, 9 and 11. (6) Commission Delegated Directive (EU) 2018/741 (4) granted an exemption for the use of copper alloy containing up to 4 % lead by weight for all categories, as set out in point 6(c) of Annex III to Directive 2011/65/EU. (7) On 17 January 2020 and 20 January 2020, the Commission received two applications for renewing the exemptions set out in points 6(a) and 6(a)-I of Annex III to Directive 2011/65/EU in light of scientific and technical progress, in particular with regard to its scope. On 2 December 2019 and 17 January 2020, the Commission received two applications for renewing the exemption set out in points 6(b), 6(b)-I and 6(b)-II of Annex III to Directive 2011/65/EU and on 15 January 2020 and 16 January 2020, the Commission received two applications for renewing the exemption set out in point 6(c) of Annex III to Directive 2011/65/EU. (8) For the exemptions set out in points 6(a), 6(b) and 6(c) of Annex III to Directive 2011/65/EU, the electrical and electronic equipment category 8 ‘in vitro diagnostic medical devices’, referred to in Annex I to Directive 2011/65/EU, were to expire on 21 July 2023 and the categories 9 ‘industrial monitoring and control instruments’ and 11 ‘other electrical and electronic equipment not covered by any of the categories’, referred to in Annex I to Directive 2011/65/EU, were to expire on 21 July 2024. On 20 January 2023, two renewal applications were received for each exemption set out in points 6(a) and 6(b) of Annex III to Directive 2011/65/EU and specifically regarding those three categories. In accordance with Article 5(5), second subparagraph, of Directive 2011/65/EU, their submission extended the validity of the existing exemptions until a decision on the renewal applications is taken. (9) In order to evaluate the applications received, a technical and scientific assessment study was carried out and finalised in 2022 (5). A further study focussing on the categories for which a renewal was requested at a later stage was carried out and finalised in 2024 (6). The evaluations included stakeholder consultations in accordance with Article 5(7) of Directive 2011/65/EU. (10) The evaluation of the requested exemption renewal concluded that, regarding the exemption set out in point 6(a)-I of Annex III to Directive 2011/65/EU, lead is still necessary in steel to achieve certain machining properties. A substitution or elimination in batch hot dip galvanised steel is currently not technically feasible nor economically viable. However, both technical applications can be split between points 6(a)-I and 6(a)-II of Annex III to Directive 2011/65/EU, to allow a more dedicated examination in the next review. (11) In order to provide sufficient time to substitute lead in steel and to avoid negative impacts, which outweigh the benefits of a substitution, it is appropriate to grant a short-term validity period for those applications, in accordance with Article 5(2), first subparagraph, of Directive 2011/65/EU. As regards points 6(a), 6(a)-I and 6(a)-II of Annex III to Directive 2011/65/EU, it is appropriate to set one expiry date for all categories listed in Annex I of that Directive. (12) The exemption set out in point 6(a) of Annex III to Directive 2011/65/EU should expire 12 months after the date of the decision on the renewal application, in accordance with Article 5(6) of that Directive. (13) As regards the exemption set out in point 6(b)-I of Annex III to Directive 2011/65/EU concerning lead in aluminium stemming from lead-bearing aluminium scrap recycling, it was found that the lead concentration can further be reduced to 0,3 % by weight in aluminium. That should be set out in a new point, specifying that such aluminium is a casted alloy. (14) The use of intentionally added lead in aluminium for machining purposes is no more needed for electrical and electronic equipment. Reliable substitutes for lead in aluminium exist on the market. The last application area relying on such an exemption is expected to be replaced by alternatives by 2025. In accordance with Article 5(6) of Directive 2011/65/EU, the maximum transition period of 18 months should be set to allow individual market participants in the industry to adapt. (15) It was found that the use of aluminium alloys containing lead with lead concentration below 0,4 % by weight requires redesign and requalification of electrical and electronic equipment falling under category 9 ‘industrial monitoring and control instruments’ and open-scope category 11 ‘other electrical and electronic equipment’, which requires more time for compliance when compared to other categories referred to in Annex I to Directive 2011/65/EU. Therefore, longer validity periods should be considered for those two categories. (16) As regards point 6(c) of Annex III to Directive 2011/65/EU concerning copper alloys containing up to 4 % lead by weight, it was not possible during the scientific and technical assessment to identify and define application areas that no longer require the exemption, despite many indications that lead could be successfully substituted in certain applications. Since substitutes are not sufficiently reliable, an extension of the exemption should be granted. In view of the technical evaluation, it is appropriate to set one expiry date for all categories listed in Annex I to Directive 2011/65/EU. (17) The inclusion of materials and components of electrical and electronic equipment should not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006 of the European Parliament and of the Council (7). Pursuant to point 7 of the restriction set out in point 63 of Annex XVII to Regulation (EC) No 1907/2006, lead is restricted in articles and their accessible parts with the aim of minimising children’s lead exposure from articles supplied to the general public. Lead in those articles or accessible parts is restricted to not more than 0,05 % by weight if those components may be placed in the mouth of children. To ensure compliance with the protection level established by Regulation (EC) No 1907/2006, the approved exemption entries should be marked with a footnote, which further restricts the applications in accordance with point 7 of the restriction set out in point 63 of Annex XVII to Regulation (EC) No 1907/2006. (18) Directive 2011/65/EU should therefore be amended accordingly, HAS ADOPTED THIS DIRECTIVE:

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Source: EUR-Lex (Cellar) · retrieved 2026-10-14 · Text as adopted (Official Journal); later amendments are not incorporated in this text.