EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2020) XXX  draft  
 
COMMISSION DELEGATED DIRECTIVE (EU) .../…  
of XXX  
amending, for the purposes of adapting to scientific and technical progress, Annex IV to 
Directive  2011/65/EU of the European Parliament and of the Council as regards the 
validity period of an exemption for the use of mercury in electric rotating connector s 
used in intravascular ultrasound imaging systems  
(Text with EEA relevance)   EN 1  EN 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 ex emption 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 substance s 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 i nclusion 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 whic h 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 substitu tion 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 substitutio n; 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 Commis sion (the Commission) shall 
include materials and components of EEE for specific appli cations 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 submi tting 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 numerous3 
requests from economic operators, according to the provisi ons 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 m ercury in electric rotating connectors 
used in intravascular ultrasound imaging systems capable of high op erating frequency (>  50 
MHz) modes of operation .  
                                                 
1 OJ L 174, 1.7.2011, p. 88.  
2 OJ L 396, 30.12.2006, p. 1. 
3 The list is given at: http://ec.europa.eu/environment/waste/rohs_eee/adaptation_en.htm  EN 2  EN 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 evaluat ing 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 consultation4 on the application. No contribution s were made to the 
stakeholder consultation.  
The final report containing the assessment of the application was published5; stakeho lders 
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 remain ing silent . All necessary steps relating to 
exemptions from the substance restriction pursuant to Article s 5(3) to 5(7) have been 
performed .6 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 based 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 f or 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 substitu tes 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 .  
                                                 
4 Consultation period : from 31 October 2018 until 19 December 2018 . 
5 https://op.europa.eu/en/publication -detail/ -/publication/7e6bf135 -f0b9-11e9 -a32c -
01aa75ed71a1/language -en/format -PDF/source -120742148    
6 A list of  the required administrative  steps is available on the Commission website . Current stage of the 
procedure can  be viewed for each draft delegated act in the Interinstitutional Registry of Delegated Acts 
at https://webgate.ec.europa.eu/regdel/#/home . EN 3  EN 3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The Delegate d Directive grants an  extension of the validity period of an  exemption listed in 
Annex IV of Directive  2011/65/EU, for the use of  mercury  in specific applications.  
The inst rument is a Delegated Directive, as provided for by Directive 2011/65/EU, and in 
particular meeting the relevant requirements of Article 5(1)(a) thereof.  
The objective of the Delegated Directive  is to contribute to the protection of human health and 
the environment and approximate the provisions for the functioning of the internal market in 
the field of electrical and electronic equipment , by allowing the use of otherwise banned 
substances for specific applications, in line with the provisions and under the conditions of 
RoHS  and the therein established procedure for the adaptation of the Annexes  III and IV  to 
scientific and technical progress.  
In accordance with the principle of proportionality, the measure does not go beyond what is 
necessary to achieve its objective.  
The proposal has no implications for the EU budget.  EN 4  EN COMMISSION DELEGATED DIRECTIVE (EU) .../…  
of XXX  
amending, for the purposes of adapting to scientific and technical progress, Annex IV to 
Directive  2011/65/EU of the European Parliament and of the Council as regar ds the 
validity period of an exemption for the use of mercury in electric rotating connectors 
used in intravascular ultrasound imaging systems  
(Text with EEA relevance)  
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 Par liament and of the Council of 
8 June 2011 on the restriction of the use of certain hazardous substances in electrical and 
electronic equipment1, and in particular Article 5(1)(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 th at Directive.  
(3) Mercury is a  restricted substance listed in Annex II to Directive 2011/65/EU.  
(4) By Delegated Directive (EU) 2015/5742, the Commission granted an exemption for  
the use of mercury in intravascular ultrasound imaging systems (“the exemption”) , by 
including that application in Annex IV to Directive 2011/65/EU. T he exemption was 
to expire on 30 June 2019, in accordance with the third subparagraph of Article 5(2) of 
that Directive . 
(5) The Commission received an application for renewal of the exemption ( “the renewal 
request”) on 6 October 2017 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 evaluatio n of the renewal request included stakeholder consultations in 
accordance with Article 5(7) of Directive 2011/65/EU.  The comments received during 
these consultations were  made publicly available on a dedicated website.  
                                                 
1 OJ L 174, 1.7.2011, p. 88.  
2 Commission Delegated Directive (EU) 2015/574 of 30 January 2015 amending, for the purposes of 
adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of 
the Council as regards an exemption for mercury in intravascular ultrasound imaging systems (OJ L 94, 
10.4.2015, p. 6).  EN 5  EN (7) Mercury is used in electric rotating connectors of intravascular ultrasound imaging 
systems  which  provide the electrical conduction path between the rotating transducer 
and stationary electronic equipment.  The use of mercury enables inter alia higher 
frequency operation whic h allows  obtaining higher resolution imaging beneficial for 
patients . 
(8) Due to the lack of alternatives, a  substitution or elimination of mercury in the 
applications concerned is  currently scientifically and technically impracticable . The 
exemption is consis tent with Regulation (EC) No 1907/2006 of the European 
Parliament and of the Council3 and thus  does not weaken the environmental and health 
protection afforded by  it.  
(9) It is, therefore, appropriate to grant t he renewal of the  exemption.  
(10) The exemption should be renewed for the maximum duration of 7 years until 30 June 
2026, in accordance with Article 4(3) and the third  subparagraph of Article 5(2) of 
Directive 2011/65/EU. In view of the results of the ongoing efforts to find a reliable  
substitution , the duration of th e exemption is unlikely to have adverse impacts on 
innovation . 
(11) Directive 2011/65/EU should therefore be amended accordingly,   
 
HAS ADOPTED THIS DIRECTIVE:  
Article 1  
Annex IV to Directive 2011/65/EU is amended as set out in the A nnex to this Directive.  
Article 2 
1. Member States shall adopt and publish, by [the last day of the 12th month after the 
date of entry into force of this Directive]  at the latest, the laws, regulations and 
administrative provisions necessary to comply with  this Directive. They shall 
forthwith communicate to the Commission the text of those provisions.  
They shall apply those provisions from [the last day of the 12th month after the date 
of entry into force of this Directive  + 1 day ]. 
When Member States adopt  those provisions, they shall contain a reference to this 
Directive or be accompanied by such a reference on the occasion of their official 
publication. Member States shall determine how such reference is to be made.  
2. Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive.  
                                                 
3 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and 
establishing a European Che micals Agency , amending Directive 1999/45/EC and repealing Council 
Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council 
Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 
2000/21/EC  (OJ L 396, 30.12.2006, p. 1).  EN 6  EN Article 3 
This Directive shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the Eu ropean Union . 
Article 4 
This Directive is addressed to the Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen