EXPLANATORY MEMORANDUM
1.CONTEXT OF THE DELEGATED ACT
This Commission Delegated Directive amends, for the purpose of adapting to technical progress, Annex IV 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) as regards an exemption for specific applications containing mercury.
RoHS 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 currently restricted substances as listed in Annex II to RoHS are the following: lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), bis(2‑ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP). Annexes III and IV to RoHS list the materials and components of electrical and electronic equipment (EEE) for specific applications exempted from the substance restriction of RoHS Article 4(1).
Article 5 provides 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 (REACH) 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.
Decisions on exemptions, and their duration, are furthermore to take into account the availability of substitutes and the socioeconomic impact of substitution; and decisions on the duration of exemptions shall take into account any potential impact on innovation. Life-cycle thinking on the overall impacts of the exemption shall apply, where relevant.
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 the RoHS Directive, 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 current Annex IV exemption 42 permits the use of mercury in electric rotating connectors used in intravascular ultrasound imaging systems capable of high operating frequency (> 50 MHz) modes of operation.
The Commission received one application for renewal of this exemption in October 2017. While exemption 42 had 30 June 2019 as expiration date, in line with the requirements of the RoHS Directive (Article 5(5), second subparagraph), it continues to apply until a decision on the renewal application is taken by the Commission.
With a view to evaluating the application for exemption, the Commission launched a study to carry out the required technical and scientific assessment, including a seven‑week online open‑ended stakeholder consultation 4 on the application. No contributions were made to the stakeholder consultation.
The final report containing the assessment of the application was published 5 ; stakeholders were notified.
Subsequently, the Commission consulted the Member States expert group for delegated acts under RoHS during an expert meeting on 21 October 2019. The experts agreed with the draft presented, with a large group of experts remaining silent. All necessary steps relating to exemptions from the substance restriction pursuant to Articles 5(3) to 5(7) have been performed. 6 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. The Council and the European Parliament were notified of all activities.
The final report highlighted in particular the following technical information and assessment:
·Intravascular ultrasound (IVUS) imaging is a technique that emits sound energy from a transducer at the tip of a small catheter that is guided into the coronary arteries of the heart. Sound waves reflected from vascular tissues are received by the transducer and sent to the system console, where a high resolution, cross sectional image is displayed in real time. The IVUS technique provides in vivo visualization of the coronary artery lumen, coronary artery wall morphology, and devices (such as stents) at or near the surface of the coronary artery wall. Mercury is used in slip rings which provide the electrical conduction path between the rotating transducer and stationary electronic equipment. The use of mercury enables inter alia higher frequency operation which allows obtaining higher resolution imaging beneficial for patients.
·Currently, the substitution of mercury in applications concerned is technically impracticable.
The evaluation results show that the specific exemption would not weaken the environmental and health protection afforded by the REACH Regulation, 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 validity period until 30 June 2026 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.