EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2021) 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 an 
exemption for the use of lead in bismuth strontium calcium copper oxide 
superconductor  cables and wires and lead in their electrical connections   EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
This Commission Delegated Directive amends, for the purpose of adapting to technical and 
scientific progress, Annex IV to 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 ( ‘the RoHS Directi ve’)1 as regards an exemption for specific 
applications containing  lead. 
Article 4 of the RoHS Directive restricts the use of certain hazardous substances in electrical 
and electronic equipment (EEE). Currently, 10 substances are restricted and listed in A nnex II 
to the Directive: 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 the RoHS Directive list the materials and components of EEE for 
specific applications exempted from the substance restrictions in Article  4(1) of the Directive . 
Article  5 provides for Annexes III and IV to be adapted to scientific and technical progress 
(on the granting, renewing and revoking of exemptions). Under Article  5(1)(a), exemptions 
are to be included in Annexes III and IV only if this does not weaken the environmental and 
health protection afforded by Regulation  (EC) No  1907/2006 (REACH)2 and if any of the 
following conditions is fulfilled:  
– the elimination or substitution of the substance  via design changes or materials and 
components that 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;  
– the total negative environmental, health and consumer safety impacts of substitution 
are likely to outweigh the total environmental, health and consumer safety be nefits.  
Decisions on exemptions, and their duration, must  take into account the availability of 
substitutes and the socio -economic impact of substitution. Decisions on the duration of 
exemptions must take into account any potential impact on innovation. Li fe-cycle thinking on 
the overall impact of the exemption must apply, where relevant.  
Article 5(1) of the RoHS Directive provides for the Commission to include materials and 
components of EEE for specific applications in the lists in Annexes  III and IV by m eans of 
individual delegated acts pursuant to Article  20. Article  5(3) and Annex  V establish the 
procedure for submitting exemption applications.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The Commission receives numerous requests from economic operators to grant or renew 
exemptions according to Article 5(3) and Annex V to the RoHS  Directive3. 
                                                 
1 OJ L 174, 1.7.2011, p. 88 . 
2 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 Chemicals Agency (OJ L 396, 30.12.2006, p . 1). 
3 The list is available at http://ec.europa.eu/environment/waste/rohs_eee/adaptation_en.htm . EN 2  EN On 25 March 2019, the Commission received one application  for a new entry in Annex IV to 
the RoHS  Directive . The requested exemption  concerns the use of lead in superconducting 
material  and the  related  electrical connections  in specific devices.  
In August 2019 , the Commission launched a study4 to evaluate how this new exemption  was 
being applied  and carry out the required technical and scientific assessment . The study , which 
includ ed an eight -week public  stakeholder consultation , finished  in July 2020 . Information 
about  the consultation was provided on the project website5, although  no contribution s were 
received in response to  the consultation.  
The Commission consulted the Member State expert group for delegated acts under  the RoHS 
Directive on 23 February 2021 . Some experts agreed with the drafts that were presented, 
while  many  experts did not comment . The Commission  carried out all the requisite procedural 
steps relating to exemptions from the restrictions on substances under  Articles 5(3) to 5(7)6, 
and the Council and the European Parliament were notified of all activities in this context.  
The technical and scientific assessment  report highlighted that:  
 Lead can be added to bismuth strontium calcium copper oxide material (lead -doped 
BSCCO). This material can be used in superconducting components like cables and 
wires  which creat e an electromag netic circuit  for medical devices or (industrial) 
monitoring and control instruments (e.g. magnetic resonance imaging devices (MRI) 
or nuclear magnetic resonance  (NMR)  spectrometers) . Tin-lead solder is used to 
connect these superconducting components.  
 The addition of lead to BSCCO provides technical and functional advantages  such as 
stronger magnetic fields and higher critical temperature , which  cannot be achieved  
without the use of lead.  
 For the connections, t here is no other alternative  material  available  for tin -lead solder 
with the same reliable properties  (e.g. sufficient ductility  and low electrical r esistivity 
at low temperatures).  
 The elimination or substitution of lead is scientifically and technically not practicable 
without loss of perfo rmance.  Substitut ing or eliminat ing lead in the superconducting 
material and the related solders is not currently , or in the foreseeable future expected 
to be , scientifically or technically practicable.  
 The technical and functional  advantages can result in  higher  resolution images for 
medical diagnosis or for research and innovation, and they allow more stable 
operation of NMR or MRI.  The total amount of lead placed on the market is 
expected to be around 15.5 kg per year.  
 Lead -doped BSCCO  will likely be used for stronger magnetic field strengths , 
whereas  lead-free technology can be used to generate lower magnetic  field strengths 
for less demanding conditions. Excluding lower field strengths from the scope of the 
exemption is not commensurate, as it would  potential ly limit innovation for lead -
doped BSCCO  (e.g. smaller devices)  and the economic ally more favourable  
alternatives in the lower field strengths.  
                                                 
4 The f inal report from  the study is available at  https://op.europa.eu/en/publication -detail/ -
/publication/f44f2383 -dd0a -11ea -adf7-01aa75ed71a1/language -en/fo rmat-PDF/source -146144383 .  
5 Consultation period: 3 December 2019 to 27 January 2020 (https://rohs.exemptions.oeko.info/ ).  
6 A list of the required administrative steps is available on the Commission website . The current stage of 
the procedure can be viewed for each draft delegated act in the Inter -institutional Registry of Delegated 
Acts at https://webgate.ec.europa.eu/regdel/#/home . EN 3  EN 3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The evaluation results show that granting the exemption would n ot weaken the environmental 
and health protection afforded by the REACH Regulation, in accordance with Article 5 of 
Directive 2011/65/EU.  
One of the relevant criteria specified in Article 5(1)(a) is met , namely that t he ‘elimination or 
substitution via de sign changes or materials and components which do not require any of the 
materials or substances listed in Annex II is scientifically or technically impracticable ’. 
Therefore, the  exemption is to be granted and an expiry date is to be set.  
The proposed act  grants an exemption  from the substance restrictions in Annex II to Directive 
2011/65/EU, to be listed in Annex IV, for the use of lead in BSCCO superconductor cables 
and wires and in the  related  electrical connections.  
As no reliable substitutes are expec ted in the near future, it is appropriate to grant the 
exemption until 30 June 2027. The granted validity period is not expected to have adverse 
effects  on innovation.  
The legal  instrument is a delegated d irective, as provided for in Directive 2011/65/EU  and 
meeting the relevant requirements of Article 5(1)(a)  of the Directive . 
The objective of the delegated directive is to help protect human health and the environment, 
and harmonise provisions for the functioning of the single market in the field of EEE, by 
allowing the use of otherwise banned substances for specific applications, in line with the 
RoHS Directive and the procedure established therein for adapt ing Annexes  III and  IV to the 
Directive  to scientific and technical progress.  
The delegated directi ve 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 regards an 
exemption for the use of lead in bismuth strontium calcium copper oxide 
superconductor cables and wires and lead in their electrical connections  
THE EUROPEAN COMMISSION,  
Having regard t o the Treaty on the Functioning of the European Union , 
Having regard to Directive 2011/65/EU of the European Parliament 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), point (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 th at Directiv e. 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 th at Directive.  
(2) The categories of electrical and electronic equipment  (EEE)  to which Directive 
2011/65/EU applies are listed in Annex I  to that Directive . 
(3) Lead is a restricted substance listed in Annex II to Directive 2011/65/EU.  
(4) On 25 March 2019 , the Commission received an application  made in accordance with  
Article 5(3) of Directi ve 2011/65/EU for an exemption to be listed in Annex IV to that 
Directive, for the use of lead in bismuth strontium calcium copper oxide 
superconductor for use in cables and wires and lead in related electrical connections to 
other EEE components (‘the req uested exemption’). Lead -doped  BSCCO can be used 
to creat e superconducting magnetic circuits for medical devices and monitoring and 
control instruments.  
(5) The evaluation of the requested exemption included stakeholder consultation s in 
accordance with Article  5(7) of Directive 2011/65/EU.  The comments received during 
those consultations were made publicly available on a dedicated website.  
(6) Lead -containing solders are used to connect the superconducting wires and cables to 
other EEE components. There is current ly no lead-free alternative available on the 
market that would provide a sufficient level of reliability for applications, where 
properties such as  ductility and low electrical resistivity at low temperatures  are 
required . 
(7) The evaluation of the request ed exemption , which included a technical and scientific 
assessment study2, concluded that t he addition of lead to BSCCO provides technical 
and functional advantages  that cannot be achieved  without the use of lead. Those 
                                                 
1 OJ L 174, 1.7.2011, p. 88 . 
2 Study to assess seven exemption requests relating to Annex III and IV to Directive 2011/65/EU . EN 5  EN technical and functional advantages consist in higher resolution images for medical 
diagnosis or for research and innovation, and allow a more stable operation mode of 
the relevant applications.  The addition of lead to BSCCO makes it possible to produce 
more efficient and reliable equipment , which  is beneficial for health care and 
innovation . 
(8)  It is currently not possible to substitute or otherwise eliminate lead in the 
superconducting material and the related solders  with the same technical performance , 
nor is it expected to be so in the fo reseeable future . The requested exemption is 
consistent with Regulation (EC)  No 1907/2006 of the European Parliament and of the 
Council3 and does not weaken the environmental and health protection afforded by  it. 
(9) It is, therefore, appropriate to grant the requested exemption . 
(10) The technical advantages of the lead -doped BSCCO -material have the potential to 
promote improvements and innovation in medical diagnostics and in research. T he 
duration of the exemption is unlikely to have adverse impacts on innovation . 
Therefore, it is appropriate to grant the exemption  for an extensive validity period , in 
accordance with Article 5(2), first subparagraph, of Directive 2011/65/EU.  
(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 Annex to this Directive.  
Article 2  
1. Member States shall adopt and publish, by [ OP please insert the date: the last day of 
the 5th 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 the text of those provisions to  the 
Commission.  
They shall apply those provisions from [ OP please insert the date: the last day of the 
5th 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 th is 
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.  
Article 3  
This Directive shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
                                                 
3 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning the Registration, Evaluation, Authorisatio n and Restriction of Chemicals (REACH), 
establishing a European Chemicals 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/E  EC and Commissi on 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 4  
This Directive is addressed to the  Member States.  
 
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN