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 
lead in solder in one interface of large area stacked die elements. 
(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 lead. 
Directive 2011/65/EU of the European Parl iament and of the C ouncil of 8 June 2011 
(RoHS 2) restricts the use of certain h azardous 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. 
RoHS 2 Annexes III and IV list exemptions of  materials and components from the RoHS 2 
substance restrictions. Article  5 provides for the adaptation (inclusion and deletion of 
exemptions) of the Annexes to scientific and technical progress. Pursuant to Article 5, 
exemptions shall be included in Annexes III and IV, provided that such inclusion does not 
weaken the environmental and health protect ion afforded by Regul ation (EC) No 1907/2006 
and where any of the following conditions is fulfilled: their elimination or substitution via design changes or materials an d 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 negativ e environmental, health  and consumer safety 
impacts caused by substitution are likely to outw eigh the total environmental, health and 
consumer safety benefits thereof. 
RoHS 2 Article 5 establishes a procedure for th e adaption of the Annexes to scientific and 
technical progress. RoHS 2 Article 5(1)(a) provides that the Commission 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.  
2. CONSULTATIONS
 PRIOR  TO THE  ADOPTION  OF THE  ACT 
In line with the provisions for granting, re newing or revoking an exemption, which allow 
stakeholders to apply for an exemption from th e substance restrictions (Article 5(3)), the 
Commission has received more th an 40 requests for new exemptions since the publication of 
RoHS 2. With a view to the evaluation of  the requested exemptions, the Commission 
commissioned a study and carried out the re quisite technical and scientific assessment 
including an official stakeholder consultation.1 The final study is available on the consultants' 
webpage; stakeholders and Me mber States were notified.2 The project page is accessible via 
the DG Environment webpage.  
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 28 June 2013, a consolidated 
recommendation with all necessary background information was sent out on 20 September 2013 and experts were invited to comment on the proposal by 15 November 2013. The expert group unanimously supported the proposal. All nece ssary steps pursuant to Article 5(3) to (7) 
have been performed. Council and Parliame nt were notified of all activities. 
                                                
 
1 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. 
2 http://rohs.exemptions.oeko.info/fileadmi n/user_upload/RoHS_VII/20130930_RoHS-
2_Exemption_Evaluation_Pack-2.pdf  (pages 27-45) .  
EN 3   EN Technical background information (for fu rther information see footnote 2): 
SDE (stacked die elements) detector technology is used in X-ray detectors of CT (computed 
tomography) and X-ray systems (mainly medica l devices, but also monitoring and control 
instruments). It offers advantages, in particul ar an up to 30 % increase in the signal-to-noise 
ratio, which enables reducing the X-ray dose patie nts are exposed to in order to achieve a 
good image. Lower X-ray doses reduce the patient's  risk of contracting cancer. SDE detectors 
offer a combination of technological advantag es, which other detectors currently cannot 
provide. Large area SDE detectors cannot yet be produced with lead-free solders. Alternative 
detector technologies that do not depend on th e use of lead or other RoHS-restricted 
substances are currently not available. The substitution and the elimination of lead are 
therefore scientifically and t echnically impracticable for th e above-mentioned applications. 
An exemption should be granted until the end of 2019. In view of the relatively long 
innovation cycles of this sector this is a relati vely short transition period which is unlikely to 
have adverse impacts on innovation. 
In accordance with the repair-as-produced principl e of RoHS 2 Article 4(4), which is meant to 
extend the lifetime of compliant products once placed on the market, spare parts shall benefit 
from this exemption past its e nd date without time limitations. 
The specific exemption does not weaken the envi ronmental and health protection afforded by 
Regulation (EC) No 1907/2006 (REACH). 
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, fo r the use of lead 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. 
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 
adaption of the Annexes to scie ntific and technical 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 4   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 
lead in solder in one interface of  large area stacked die elements. 
(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,
3 and in particular Article 5(1)(a) thereof, 
Whereas: (1) Directive 2011/65/EU prohibits the use of lead in electrical and electronic equipment 
placed on the market.  
(2) SDE (stacked die elements) detector tec hnology is used in X-ray detectors of 
computed tomography (CT) and X-ray systems. It offers advantages for patients as it 
reduces the necessary X-ray dose exposure.  Large area SDE detectors cannot yet be 
produced with lead-free solders. The subs titution and the elimination of lead are 
therefore scientifically and technically impracticable for the above-mentioned 
applications. 
(3) The use of lead in large area stacked die elements with more than 500 interconnects 
per interface used in  X-ray detectors of CT and X -ray systems should therefore be 
exempted from the prohibition until 31 December 2019. In view of the innovation cycles of the medical devices and monitoring and control instruments sectors this is a 
relatively short transition pe riod which is unlikely to have adverse impacts on 
innovation. 
(4) In accordance with the repair-as-produced principle of Directive 2011/65/EU, which is 
meant to extend the lifetime of compliant products once placed on the market, spare parts shall benefit from this exemption past its end date w ithout time limitations. 
(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. 
                                                
 
3 OJ L 174, 1.7.2011, p. 88.   
EN 5   EN 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 sixth month 
after entry into force at the latest. They shall forthwith communicate to the Commission the text of those provisions. 
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   José Manuel BARROSO