EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2015) 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, cadmium, hexavalent chromium, and po lybrominated diphenyl ethers (PBDE) in 
spare parts recovered from and used for the repair or refurbishment of medical devices 
or electron microscopes 
(Text with EEA relevance) 
  
EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT 
Subject: Commission Delegated Decision 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 for applica tions containing lead, cadmium, hexavalent 
chromium, and polybrominated diphenyl ethers (PBDE). 
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 hazard ous substances (lead, mercury, cadmium, 
hexavalent chromium, polybrominated biphenyl s, and 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 Annex II  of RoHS 2. Annexes III and IV of RoHS 2 list 
the materials and components of EEE for specifi c applications exempted from the substance 
restriction in RoHS 2 Article 4(1). 
RoHS 2 Article 5 provides for the adaptation to  scientific and techni cal progress (inclusion 
and deletion of exemptions) of Annexes III and IV. Pursuant to Article 5(1)a, exemptions 
shall be included in Annexes II I 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 establishes a procedure for the adaptati on of the Annexes to sc ientific and technical 
progress. Article 5(1) provides that the European Commission (t he 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  in accordance with RoHS 2 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 allows 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 and almost 100 requests to renew existing exemptions. 
The Commission received an application in Ju ne 2013 in relation to us e of spare parts in 
medical devices in the context of RoHS; the use of spare parts as requested in the application 
is different than exemption 31 in Annex IV. W ith a view to evaluate the application, the 
Commission commissioned studies and carried out the requi site technical and scientific 
assessment including an offici al stakeholder consultation2 for the application3. 
                                                 
1 OJ L 174, 1.7.2011, p. 88. 
2 http://ec.europa.eu/environment/consultations/rohs9_en.htm ; consultation period from 20.12.2013 to 
28.02.2014 
3 The list of consulted stakeholders is regularly upda ted and maintained by the consultants in cooperation 
with the Commission, and includes electronics related industry organisations, manufacturers and 
suppliers, recyclers, consumer associations, NGOs , academia, Member States' representatives, etc.  
EN 3   EN The final report for the evaluation of this app lication and a subsequent more comprehensive 
study on the broader issue of refurbishment of medical devices in the context of RoHS, both 
prepared by consultants Oeko Institute and ap proved by DG Environment, are available on 
the consultants' webpage4; stakeholders and Member States were notified. The project page is 
accessible via the DG Environment webpage5. 
Subsequently, the Commission consulted the o fficial expert group fo r delegated acts under 
RoHS 2. A meeting with consultants a nd experts was held on 23 February 2015, a 
consolidated draft proposing a replacement of previous exem ption 31 in order to allow a 
better use of spare parts recove red from used equipment which was not already placed on the 
EU market was sent out after the meeting and experts were i nvited to comment on the draft by 
15 April 2015. The expert group broadly supported the consolidated proposal to exempt lead, 
cadmium, hexavalent chromium, and polybrominat ed diphenyl ethers (PBDE) in spare parts 
recovered from and used for the repair or refurb ishment of medical device s, including in vitro 
diagnostic medical devices, or el ectron microscopes and their accessories. All necessary steps 
pursuant to Article 5(3) to (7 ) have been performed. Council an d Parliament were notified of 
all activities.  
Article 4(4)(b) of the RoHS 2 Directive permits  the use of spare parts containing Annex II 
substances, for the repair, the reuse, the updating of functionalitie s or the upgrading of 
capacities of medical devices placed on the EU market before 22 July 2014. This article 
therefore does not apply to equipment placed on the market after this date. Recital (20) of 
RoHS 2 recall that as product reuse, refurbis hment and extension of lifetime are beneficial, 
spare parts need to be availa ble. According to the final report, the following technical 
information was discussed in public consultations  and collected (for further information see 
footnote 4) as major aspects in the evaluation results:  
– Refurbishment practices are well established (for imaging equipment such as 
magnetic resonance imaging devices, com puter tomography devices, in-vitro 
diagnostic devices), beginning (patient mon itoring devices), or generally in place 
(electron microscopes). 
– Some of the reused spare parts will co ntain small amounts of lead, cadmium, 
hexavalent chromium, and/or PBDE. 
– Repairable assemblies in medical equi pment generally have a good quality 
closed-loop business-to-business system. 
– In the above mentioned cases, the reuse of parts from used assemblies will have a 
smaller negative impact on the environment th an if there was no reuse of spare parts. 
– Existing exemption 31 does not allow for the use of spare parts recovered from used 
equipment which was not already placed on the EU market thus limiting the availability of reused spare parts for the repair and refu rbishment of existing products 
in the EU market; 
– Not granting the exemption would result in negative impacts to the environment in 
terms of consumption of resources and in terms of greater quan tities of waste that 
                                                
 
4 Direct link to evaluation and recommendation: 
http://rohs.exemptions.oeko.info/fileadmin/user_upl oad/ROHS_Pack5/201410_RoHS_Ex_Pack5_Final_Report_
final.pdf  (pages 26-55) 
http://rohs.exemptions.oeko.info/fileadmin/user_upl oad/reports/20150312_RoHS_scope_review_final_a.pdf  
(pages 70–104). 
5 http://ec.europa.eu/envi ronment/waste/rohs_eee/ studies_rohs1_en.htm .  
EN 4   EN would outweigh the positive impacts of restricting the reuse of recovered medical 
parts containing lead, cadmium, hexavalent chromium, and PBDE. 
– Comparing the environmental impacts of using refurbished parts in the above 
mentioned cases to those of substituting refurbished parts with new ones, demonstrates that the total negative envi ronmental, health and consumer safety 
impacts of substitution would outweigh the total benefits thereof. 
With respect to a replacement of the existing exemption 31 in Annex IV with the following 
one " Lead, cadmium, hexavalent chromium, and pol ybrominated diphenyl ethers (PBDE) in 
spare parts recovered from and used for the repair or refurb ishment of medical devices, 
including in vitro diagnostic me dical devices, or electron micr oscopes and their accessories, 
provided that the reuse takes  place in auditable closed-loop business-to-bus iness return 
systems and that each reuse of par ts is notified to the customer. 
Expires on: 
(a) 21 July 2021 for the use in medical devices other than in-vitro diagnostic medical 
devices; 
(b) 21 July 2023 for the use in in-vitro diagnostic medical devices; 
(c) 21 July 2024 for the use in electron microscopes and their accessories.", 
the evaluation results show that the relevant criteria specified in Article 5(1)(a) are fulfilled 
and the inclusion of the specific application in the exemptions listed in Annex IV is thus 
justified. The proposed exemption does not weak en the environmental and health protection 
afforded by Regulation (EC) No 1907/2006. The total negative enviro nmental and health 
impacts of alternatives outw eigh the benefit of substitution. Existing exemption 31 in Annex 
IV should be replaced with the proposed one. 
In order to ensure a smooth transition for ma rket operators from the old to the proposed 
provisions and to prevent single market disruptio ns, the provisions of th is directive should be 
applied simultaneously by all Member States 18 m onths after the date of  entry into force of 
this directive. 
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 lead, cadmium, hexavalent 
chromium, and polybrominated diphenyl ethers  (PBDE) in specific applications. The 
proposed act revokes the existing exemption 31 of RoHS 2 Annex IV; the exemption 31 of 
RoHS 2 Annex IV shall expire 18 mont hs after the date of the decision. 
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 
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 
lead, cadmium, hexavalent chromium, and poly brominated diphenyl ethers (PBDE) in 
spare parts recovered from and used for the re pair or refurbishment of medical devices 
or electron microscopes 
(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 lead, cadmium, hexavalent chromium, and 
polybrominated diphenyl ethers (PBDE) in el ectrical and electronic equipment placed 
on the market. 
(2) Refurbishment practices exists for imaging equipment such as magnetic resonance 
imaging devices, computer tomography devi ces, in-vitro diagnostic devices, patient 
monitoring devices, and electron microscope s. Some of the recovered spare parts 
reused for refurbishment will contain small amounts of lead, cadmium, hexavalent chromium, or PBDE. 
(3) The exemption set out in point 31 of A nnex IV to Directive 2011/65/EU does not 
allow for the use of spare parts recovered from used equipment which was not already 
placed on the Union market thus limiting the availability of recovered spare parts. 
(4) A comparison of the environmental impacts of  using refurbished parts in such cases 
with the environmental impacts of substi tuting refurbished parts with new ones 
demonstrates that the total negative environmental, health and consumer safety impacts of substitution would outweigh the total benefits thereof. 
(5) Considering that the substance restriction wi ll start to apply to the different equipment 
concerned on different dates as provided fo r in Article 4(3) of Directive 2011/65/EU, a 
different expiry date for the exemption s hould be set for each type of equipment. 
(6) Directive 2011/65/EU should therefore be amended accordingly. 
(7) In order to ensure a smooth transition for market operators from the existing 
provisions to those specified in  this Directive and to prev ent single market disruptions, 
it is appropriate to set a date for the simu ltaneous application by the Member States of 
                                                
 
6 OJ L 174, 1.7.2011, p. 88.  
EN 6   EN their national provisions which also provides a reasonable period of time after the date 
of transposition 
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, as concrete date, the 
last day of the 9th month after entry into force of this directive ], the laws, regulations 
and administrative provisions necessary to co mply with this Directive. They shall 
forthwith communicate to the Commissi on the text of those provisions. 
They shall apply thos e provisions from [ OP, please insert, as  concrete date, 18 
months after the date of entry into force of this directive ]. 
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  […]