EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2014) XXX  draft 
  
COMMISSION DELEGATED DIRECTIVE ../…/EU 
of XXX  
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 
(Text with EEA relevance) 
  
EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT 
Subject: Commission Delegated Directive amending, for the purposes of ad apting to technical 
progress, Annex IV of the Directive 2011/65/EU  of the European Parliament and of the 
Council as regards an exemption fo r applications containing mercury. 
Directive 2011/65/EU of the European Parl iament and of the C ouncil of 8 June 2011 
(RoHS 2)1 restricts the use of certain hazardous  substances (lead, mercury, cadmium, 
hexavalent chromium, polybrominated biphe nyls, polybrominated diphenyl ethers) in 
electrical and electronic equi pment. RoHS 2 (recast) entered into force on 21 July 2011. 
The restricted substances are listed in A nnex II of RoHS 2. Annexes III and IV list 
exemptions of materials and components from the substance restrictions under Article 4(1). 
Article 5 provides for the adaptation to scie ntific and technical progress (inclusion and 
deletion of exemptions) of Annexes III and IV. Purs uant to Article 5(1)a, exemptions shall be 
included in Annexes III and IV, provided that  such inclusion does not weaken the 
environmental and health protection afforded  by Regulation (EC) No 1907/2006 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 nega tive environmental, health and consumer safety impacts caused 
by substitution are likely to ou tweigh the total environmental, health and consumer safety 
benefits thereof. 
Article 5 of RoHS 2 establishes a procedure for the adaptation of the Annexes to scientific 
and technical progress. RoHS 2 Article 5(1)  provides that the Co mmission shall include 
materials and components of EEE fo r specific applicati ons in the lists in Annexes III and IV 
by means of individual delegated acts in accordance with Article 20.  
2. CONSULTATIONS
 PRIOR  TO THE  ADOPTION  OF THE  ACT 
In line with the provisions in Article 5(3) and Annex V fo r granting, renewing or revoking an 
exemption, which allow stakeholders to apply fo r an exemption of the restricted substance , 
the Commission has received almost 50 requests for new exemptions since the publication of 
RoHS 2. With a view to evaluate the re quested exemptions, the Commission commissioned 
several studies and carried out the requisite technical and scie ntific assessment including an 
official stakeholder consultation2 for each application.3 The final report, written by 
consultants Oeko Institute and ap proved by DG Environment, for this application is available 
on the consultants' webpage4; stakeholders and Member Stat es were notified. The project 
page is accessible via the DG Environment webpage5. 
                                                 
1  OJ L 174, 1.7.2011, p. 88. 
2  http://ec.europa.eu/environment/consultations/rohs7_en.htm ; consultation period 19 August to 11 
November 2013. 
3 The consultation list is regularly updated and maintained by the consultants in cooperation with the 
Commission, and includes electronics related industry organisations, manufacturers and suppliers, 
recyclers, consumer associations, NGOs, acad emia, Member States' representatives, etc. 
4 Direct link to evaluation and recommendation: 
http://rohs.exemptions.oeko.info/fileadmin/user_upl oad/RoHS_IX/20140422_RoHS2_Evaluation_Ex_Requests_
2013-1-5_final.pdf , pages 95-110. 
5  http://ec.europa.eu/environment/w aste/rohs_eee/studies_rohs1_en.htm.  
EN 3   EN Subsequently, the Commission consulted the o fficial expert group fo r delegated acts under 
RoHS 2. A meeting with consultants and e xperts was held on 25 June 2014, a consolidated 
recommendation with all necessary background in formation was sent out on 1 July 2014 and 
experts were invited to comment on the proposal by 25 August 2014. The expert group 
unanimously supported the proposal to exempt mercury in intravascular ultrasound imaging 
systems. All necessary steps pursuant to Article 5(3) to (7) have been performed. Council and 
Parliament were notified of all activities. 
According to the final report, the following t echnical information as  discussed in public 
consultation was collected (for further information see footnote 4): 
Mercury is used in electric rotating connector s in medical devices fo r intravascular ultrasound 
imaging. In such systems, a catheter is inse rted into a patient’s coronary artery. The 
transducer within the catheter must be rotated 360 degrees in order to scan around the entire 
artery. The use of mercury eliminates the noise generated by metal on metal contact under 
rotation, and supports the high peak power requirements for the device by increasing the metal contact area. 
Based on current technology, substitution of merc ury is not possible because it is the only 
conductive metal which is a liquid at room temper ature. Any type of so lid contact increases 
electrical resistance,  decreases life through temperat ure build up and wear, introduces 
electrical noise through variation in resistan ce via mechanical non-uniformities, decreases 
bandwidth through introduction of resistance an d limits power handling through the need to 
reduce surface area of the contact. 
At present, the mercury component in the devi ce cannot be replaced with a RoHS compliant 
component. Design alternatives such as the use of silver graphite or the use of rotary inductive 
couplers do not produce the same high quality  performance as the mercury based device, 
which has unique capabilities that can have a positive impact on patients' health. 
Both the substitution of mercury in electric  rotating connectors in medical devices for 
intravascular ultr asound imaging and the elimination of  mercury via substitution of the 
connector or the device are technically impracti cable or have negative overall impacts due to 
an impact on patients' health. 
In light of Article 5(1)(a) criteria one and th ree, an exemption is justified, and should be 
granted until mid-2019. In view of the relativel y long innovation cycles fo r medical devices in 
comparison to consumer products this is a rath er short transition period which is unlikely to 
have adverse impacts on innovation  as no substitute s are available today or  before the date of 
June 2019. 
The specific exemption does not weaken the envi ronmental and health protection afforded by 
Regulation (EC) No 1907/2006 (REACH) in acco rdance with Article 5 of Directive 
2011/65/EU. 
3. LEGAL
 ELEMENTS  OF THE  DELEGATED  ACT 
The proposed act grants an exemption from the s ubstance restrictions in  Annex II of Directive 
2011/65/EU (RoHS 2), to be listed in Annex IV, for the use of mercury in specific 
applications. 
The proposed instrument is  a delegated directive. 
The draft delegated directive implements Di rective 2011/65/EU, and in  particular Article 
5(1)(a) thereof.  
EN 4   EN The objective of the proposed act is to ensu re legal certainty and sustainable market 
conditions for electronic  manufacturers, by allowing specific applications of otherwise banned 
substances in line with the provisions of RoHS 2 and the therein established procedure for the 
adaptation of the Annexes to scie ntific and tec hnical progress. 
In accordance with the principle of proportiona lity, the measure does not go beyond what is 
necessary to achieve its objective. 
The proposal has no implications for the EU budget.  
EN 5   EN COMMISSION DELEGATED DIRECTIVE ../…/EU 
of XXX  
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 
(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 Eu ropean Parliament and of the Council of 8 
June 2011 on the restriction of the use of cert ain hazardous substances in electrical and 
electronic equipment
6, and in particular Article 5(1)(a) thereof, 
Whereas: (1) Directive 2011/65/EU prohibits  the use of mercury in el ectrical and electronic 
equipment placed on the market.  
(2) Mercury is used in electric rotating conn ectors in medical devices for intravascular 
ultrasound imaging. Substitution of mercury or of the specific component would 
shorten product life or imp air performance significantly. 
(3) Both the substitution of mercury in the conne ctor and the elimination of mercury via 
substitution of the connector  or the device are technically impracticable or have 
negative overall impacts due to an impact on patients' health. 
(4) The use of mercury in electr ic rotating connectors used in intravascu lar ultrasound 
imaging systems capable of high operating frequency modes of operation (> 50MHz) should therefore be exempted until 30 June 2019. In view of the innovation cycles for 
medical devices this is a short transition period which is unlikely to have adverse 
impacts on innovation. 
(5) 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 Annex to this Directive. 
Article 2 
1. Member States shall bring into force the laws, regulations and administrative 
provisions necessary to comply with this Di rective by the last day of the ninth month 
after entry into force at the latest. They shall forthwith communicate to the Commission the text of those provisions. 
                                                
 
6 OJ L 174, 1.7.2011, p. 88.   
EN 6   EN 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 determin e 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. 
Article 3 
This Directive shall enter into force on the tw entieth day following that of its publication in 
the Official Journal of  the European Union . 
Article 4 
This Directive is addressed to the Member States. 
Done at Brussels, 
 For the Commission 
 The President  […]