1.CONTEXT OF THE DELEGATED ACT
This Commission Delegated Directive amends, for the purpose of adapting to technical progress, Annex III of Directive 2011/65/EU of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast) 1 (RoHS 2) as regards an exemption for specific applications containing lead.
RoHS 2 restricts the use of certain hazardous substances in electrical and electronic equipment, as provided for in its Article 4. It entered into force on 21 July 2011.
The restricted substances are listed in Annex II to RoHS 2. While the restrictions of lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, and polybrominated diphenyl ethers are in force to date, the restrictions of bis(2ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), diisobutyl phthalate (DIBP) shall apply from 22 July 2019 or later. Annexes III and IV to RoHS 2 list the materials and components of electrical and electronic equipment (EEE) for specific applications exempted from the substance restriction of RoHS 2 Article 4(1).
Article 5 makes provision for the adaptation to scientific and technical progress (inclusion, renewal, amendments and revoking of exemptions) of Annexes III and IV. Pursuant to Article 5(1)(a), exemptions are to be included in Annexes III and IV only if such inclusion does not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006 2 and where any of the following conditions is fulfilled: their elimination or substitution via design changes or materials and components which do not require any of the materials or substances listed in Annex II is scientifically or technically impracticable; the reliability of substitutes is not ensured; or the total negative environmental, health and consumer safety impacts caused by substitution are likely to outweigh the total environmental, health and consumer safety benefits thereof.
Furthermore, Article 5(1) provides that the European Commission (the Commission) shall include materials and components of EEE for specific applications in the lists in Annexes III and IV by means of individual delegated acts in accordance with Article 20. Article 5(3) and Annex V establish the procedure for submitting applications for granting, renewing, or revoking an exemption.
2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT
Since the publication of RoHS 2, the Commission has received numerous 3 requests from economic operators, according to the provisions in Article 5(3) and Annex V, for both granting new and renewing existing exemptions.
The Commission received a request for a new exemption to Annex III for use of lead in solders of sensors, actuators and engine control units (ECUs) that are used to monitor and control engine systems including turbochargers and exhaust emission controls of internal combustion engines used in equipment that are not intended to be used solely by consumers on 29 June 2017 (request no. 2017-7). The exemption was requested for category 11 4 .
With a view to evaluating the request for exemption, the Commission launched a study to carry out the required technical and scientific assessment, including a sixweek online openended stakeholder consultation 5 on the application. One contribution was received during the stakeholder consultation.
The final report containing the assessment of the application was published 6 ; stakeholders were notified.
Subsequently, the Commission consulted the Member States expert group for delegated acts under RoHS 2 during an expert meeting on 29 October 2018. The clarity of the proposed wording for this exemption was discussed by the experts. The recommended wording was subsequently amended; in particular, the word "solder" was added to the text. The experts agreed with the amended proposal presented, with a large majority of silent members. In accordance with the Better Regulation Guidelines, the draft Delegated Directive was published on the Better Regulation Portal for a four-week public feedback period. No comments were received. All applicable steps relating to exemptions from the substance restriction pursuant to Articles 5(3) to 5(7) have been performed. 7 The Council and the European Parliament were notified of all activities.
The final report highlighted in particular the following technical information and assessment:
·The conditions experienced in and close to an engine and exhaust in scope of the requested exemption can be very severe with elevated temperatures and vibration levels that may cause early failure of solder bonds. Each engine is designed with specific types of sensors (as well as actuators and ECUs) that have to be thoroughly tested to ensure that they will be reliable and the engines will meet the emissions limits as per Regulation (EU) 2016/1628 on requirements relating to gaseous and particulate pollutant emission limits and type-approval for internal combustion engines for non-road mobile machinery.
·Currently, for applications concerned, additional time is needed for testing to ensure the reliability of available lead-free alternatives.
The evaluation results for category 11 show the specific exemption would not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006 (REACH), in accordance with Article 5 of Directive 2011/65/EU. Furthermore, at least one of the relevant criteria specified in Article 5(1)(a) is met by the exemption request: Since for the applications concerned, no reliable alternatives are available today or are likely to come on the market soon, granting the exemption with the maximum validity period of five years, starting from 22 July 2019 8 , is justified. As reliable substitutes are not yet available, no negative socioeconomic impacts of substitution are to be anticipated for this period. The granted validity period is also not expected to have adverse impacts on innovation.
3.LEGAL ELEMENTS OF THE DELEGATED ACT