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 certain magnetic resonance imaging devices    
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 Directive ’)1 as regards an exemption for specific 
applications containing  lead. 
Article 4 of t he RoHS Directive restricts the use of certain hazardous substances in electrical 
and electronic equipment  (EEE). Currently, 10  substances are restricted and listed in Annex 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  adapt ed to scientific and technical progress 
(on 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  use of  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 benefits.  
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. Life -cycle  thinking on 
the overall impacts 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 means 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 t o grant or renew 
exemptions under Article 5(3) and Annex V to the RoHS Directive3. 
Exemption 27 was included in Annex  IV to the RoHS Directive by Commission Delegated 
Directive 2014/7/EU4. The expiry date set for this exemption was 30 June 2020. The 
                                                 
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 . 
4 OJ L 4, 9.1.2014, p. 57 –58.  
EN 2  EN exemption concern s the use of lead in specific components, which  are used in magnetic fields 
produced by certain medical devices. On 12 December 2018, within the timeframe for 
renewal laid down in  Article 5(5) of the RoHS  Directive , the Commission received  one 
application to renew the scope and duration of this exemption.  The exemption consist ed of 
two areas of application, (a) and (b). The applicant did not request the continuation of part (b) 
of Exemption 27 in Annex IV, which refers to specific magnets a pplied for particle therapy.  
In August 2019, the Commission launched a study5 to carry out the required technical and 
scientific assessment. The study, includ ing an eight -week public consultation, finished in July 
2020. Information about the consultation was provided on the project website6, although  no 
responses were received  to the consultation.  
The Commission consulted the Member State expert group for delegated acts under the RoHS  
Directive  on 23 February 2021.  It carried out all the required  procedura l steps relating to 
exemptions from the restrictions on substances under  Articles 5(3) to 5(7)7 and the Council 
and the European Parliament were notified of all activities  in this context . 
 
The technical and scientific assessment  report highlighted the following : 
 Lead is used in solders, termination coatings, and connections of electrical wires, 
shields and enclosed connectors to provide non -magnetic components, which are 
necessary in magnetic resonance imaging (MRI) devices for diagnostic purposes . 
 In newly designed MRI devices and components,  the substitution and elimination of 
lead is scientifically and technically practicable . 
 Old designed MRI devices are limited in their compatibility with new lead -free MRI 
components . In some MRI devices , the new de sign of lead-free components  cannot 
be used . Other old er MRI  devices will have to undergo an  elaborate redesign  
process , which shifts manufacturers ’ limited capacit y from developing new lead-free 
medical devices  with superior diagnostic capability  to replacing lead in existing  
products . 
 To address sufficiently the demand on MRI equipment for old designed MRI 
devices, which cannot be redesigned or replaced before the exemption period 
expires, the use of old MRI equipment  containing lead is still nec essary . 
 The transition to lead -free MRI equipment has progressed at different speeds for  
MRI devices with integrated  coils and those with non-integrated MRI coils.  
 Newly designed lead-free non-integrated MRI coils are available  in a sufficient 
variety for  health facilities . Due to the complexity of MRI devices with integrated 
coils  and the approval procedure  required for these , the transition to non -lead MRI 
devices requires more time . 
 Not granting the exemption may result in to premature waste of MRI devic es due to a 
lack of compatible components or redesign options. A supply gap in MRI equipment 
may also occur, which may result in poorer healthcare for patients.  
                                                 
5 Final Report of the (Pack 18) study is available at  https://op.europa.eu/en/publication -detail/ -
/publication/f44f2383 -dd0a -11ea -adf7-01aa75ed71a1 /language -en/format -PDF/source -146144383   
6 Consultation period: 3 December 2019 until 27 January 2020 https://rohs.exemptions.oeko.info/ .  
7 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  
Newly designed MRI  non-integrated coils  do not need an exemption  and MRI equipment 
including integrated coils will not need an exemption from 30 June 2024, thus these 
applications will be excluded in the new wording of the exemption.  The distinction will be 
made by the Declaration of Conformity for this model, which is nece ssary for a product 
before being placed on the market  in line with  Article 7(c) and Article 13 of the RoHS 
Directive . 
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The evaluation results show that the  exemption  to be granted  would not weaken the 
environmental and health protection afforded by the REACH Regulation , in accordance with 
Article 5 of Directive 2011/65/EU.  
The Commission’s assessment, based on the support study  and consultations, concluded that 
the exemption application  meets at least one of the criteria laid down in Article 5(1)(a) , that 
justifies renewing the exemption : ‘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 ’.  
The delegated directive renews in part Exemption 27 listed in Annex IV  to 
Directive  2011/65/EU for the use of  lead in solders, termination coatings of electrical and 
electronic components and printed circuit boards, connections of electrical wires, shields and 
enclosed connectors  for magnetic resonance imaging (MRI) device s. The old formulation in 
part (a) and (b) of the exemption 27 remains unchanged and remains list ed for clarity for 
stakeholders.  A new form ulation is introduced in part (c) and (d) which is limited to the actual 
necessary applications.  
The date  by which this exemption will expire is set in line with Article 5(2) , first 
subparagraph. As concluded by the evaluation, the state of development of substitutes justifies 
renewing the exemption for non-integrated MRI coils and for MRI devices including 
integrated coils, whereby the latter can be substituted earlier. The validity period  of the 
exemption  is not expected to have adverse impacts on innovation.  
The legal instrument is a delegated directive, as provided for  in the  Directive 2011/65/EU  and 
meeting the relevant requirements of its Article 5(1)(a).  
The objective of the delegated directi ve 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  adapti ng Annexes III and IV to the 
Directive to scientific and technical progress.  
The delegated directive 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 cert ain magnetic resonance imaging devices  
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 Parliament and of the Council of 
8 June 2011 on the restriction of t he 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 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 that Directive.  
(3) Lead  is a restricted substance listed in Annex II to Directive 2011/65/EU.  
(4) By Delegated Directive 2014/7/EU2, the Commission granted an exemption for the use 
of lead in  solders , termination coatings of electrical and electronic components and 
printed circuit boards, connections of electrical wires, shields and enclosed connectors 
that are used  in certa in medical magnetic resonance imaging  (MRI)  equipment  (‘the 
exemption’) , by including  those a pplications  in Annex IV to Directive 2011/65/EU. 
The exemption w as to expire on 30 June 2020 . 
(5) On 12  December  2018, t he Commission received an application for renew al of the  
exemption  (‘the renewal request’ ) 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 evalua tion of the renewal request  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.  
                                                 
1 OJ L 174, 1.7.2011, p. 88.  
2 Commission Delegated Directive 2014/7/EU of 18 October 2013 amending, for the purposes of 
adapting to technical progress, Annex IV to Di rective 2011/65/EU of the European Parliament and of 
the Council as regards an exemption for lead in solders, termination coatings of electrical and electronic 
components and printed circuit boards, connections of electrical wires, shields and enclosed con nectors 
which are used (a) in magnetic fields within the sphere of 1 m radius around the isocentre of the magnet 
in medical magnetic resonance imaging equipment, including patient monitors designed to be used 
within this sphere, or (b) in magnetic fields w ithin 1 m distance from the external surfaces of cyclotron 
magnets, magnets for beam transport and beam direction control applied for particle therapy (OJ L 4, 
9.1.2014, p. 57 ).  
EN 5  EN (7) The evaluation  of the renewal request, which included a  technical and scientific 
assessment study3, concluded that old design  MRI devices depend on lead -containing 
MRI components  and are highly limited in their compatibility with new lead -free MRI 
components.  That evaluation further concluded  that lead-free models of non-integrated 
MRI coils are already available. However, as concerns MRI devices  with integrated 
coils , the technical development and the approval  procedure  to develop lead -free 
solutions  require  additional time . 
(8) The use of lead in new ly designed non-integrated MRI coils and in upcoming lead -free 
MRI devices with integrated coils should be excluded from  the exemption with 
specific dates.  
(9) Not granting the renewal request could result in premature wast age of MRI devices  
due to a lack of compatible components or redesigning options. This could result in a  
supply gap of MRI equipment, which could in turn adversely affect health care for 
patients.  
(10) The total negative environmental, healt h and consumer safety impacts of substitution 
are likely to outweigh the total environmental, health and c onsumer safety benefits 
thereof. The exemption is consistent with Regulation (EC) No 1907/2006 of the 
European  Parliament and of the Council4 and thus does not weaken the environmenta l 
and health protection afforded by it.  
(11) It is, therefore, appropriate to grant the renewal of the exemption.  
(12) In order to provide compatible MRI  equipment for health services  and to allow time 
for the develop ment of  lead-free alternatives, it is appropria te to grant the renew al of  
the exemption , with a revised scope , for the maximum duration of 7 years  until 30 
June 2027, in accordance with Article 5(2 ), first subparagraph , of Directive 
2011/65/EU. In view of the results of the ongoing efforts to find a re liable substitution, 
the duration of the exemption is unlikely to have adverse impacts on innovation.  
(13) 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 pu blish, by [ OP please insert the date : the last day of 
the 5 th month after the date of entry into force of this Directive] at the latest, the 
laws, regulations and administrative pro visions necessary to comply with this 
Directive. They shall forthwith communicate the text of those provisions to the 
Commission.  
                                                 
3 Study to assess seven exemption requests relating to Annex III and IV to Directive 2011/65/EU  
(Pack  18). 
4  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),  
establishing a European Chemicals Agency, amending Directive 1999/4 5/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 They shall apply those provis ions 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 this 
Directive or be accompanied by such a reference on the occasion of their official 
publication. Member States shall determine how such refere nce 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 . 
Article  4 
This Directive is addressed to the Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN