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 bis(2 -ethylhexyl) phthalate (DEHP), butyl benzyl 
phthalate  (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts 
recovered from and used for the repair or refurbishment of medical 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 (recast)1 (the RoH S Directive) as regards an exemption for specific 
applications containing bis(2 -ethylhexyl)  phthalate (DEHP) , butyl benzyl phthalate (BBP), 
dibutyl  phthalate (DBP)  and diisobutyl  phthalate (DIBP).  
Article 4  of the RoHS Directive restricts the use of certai n 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), DEHP , BBP, DBP and DIBP.  
Annexes  III and  IV to the RoHS Directive list the materials and components of EEE for 
specific applications exem pted from the substance restrictions in Article 4(1).  DEHP, BBP, 
DBP and DIBP were  added to the list of restricted substances in Annex  II by Commission 
Delegated Directive (EU) 2015/8632 and will be prohibited in medical devices covered by the 
Directive from 22 July 2021 . The restriction will not apply to cables or spare parts for the 
repair, the reuse, the updating of functionalities or upgrading of capacity of medical devices, 
including in vitro  medical devices , placed on the market before that date . 
Article 4(4) of the RoHS Directive exclude s spare parts for the repair, the reuse, the updating 
of functionalities or upgrading of capacity of EEE placed on the market before certain  dates. 
Article  4(5) allows the reuse of spare parts recovered from medical devices placed on the 
market before 22 July 2014 (22 July 2016 in the case of in vitro  diagnostic medical devices ) 
and used in EEE placed on the market before 22 July 2024 (22 July 2026 ), provided that  the 
reuse  takes place in auditable closed -loop business -to-business return systems  and is notified 
to the customer. 
Article  5 of the Directive provides for Annexes III and IV to be  adapt ed to scientific and 
technical progress ( as regards 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)3 and any of the following conditions is fulfilled:  
– their elimination or substitution 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 benefits.  
                                                 
1 OJ L 174, 1.7.2011, p. 88 . 
2 OJ L 137, 4.6.2015, p. 10 . 
3 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). EN 2  EN Decisions on exemptions, and their duration, are to 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 pursua nt 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 requests4 from economic operators to grant or renew 
exemptions unde r the RoHS Directive ( Article 5(3) and Annex V ). 
On 17  July 2018, t he Commission received an application  for a new exemption in Annex  IV 
to allow the continued  placing  on the market  of spare parts  recovered from and used for the 
repair or refurbishment of medical devices, including in vitro  diagnostic medical devices , 
containing > 0.1% DEHP, BBP, DBP and DIBP by weight in homogeneous materials . 
According to the applicants, t he reuse of spare parts c ontaining these substances would  take 
place in auditable closed -loop business -to-business return systems and each reuse would be 
notified to the consumer . 
The request ed exemption goes beyond what is already allowed under  the RoHS Directive 
(Article  4(4) and (5), Annex  II), as it would involve  extend ing the periods of the exclusions  
for spare parts  and allow ing the use of the four substances in spare parts from medical devices 
that have not previously been placed on the EU market.  
In November 2018 , in order  to evaluat e the application for this new exemption, the 
Commission launched a study5 to carry out the required technical and scientific assessment . 
The study, which was concluded in 2020, includ ed an 8-week online stakeholder consultation , 
during which  one contribution was received . Information concerning the consultation was 
provided on the project website6. 
The Commission consulted the Member States ’ expert group for delegated acts under the 
RoHS Directive on 23 February 2021.  The Commission has taken a ll necessary steps relating 
to exemptions from the substance restriction pursuant to Article  5(3) to  (7)7. It notified the 
Council and the European Parliament of all activities  in this context . 
The technical and scientific assessment  report highlighted tha t: 
 DEHP, BBP, DBP and DIBP are used as additives in polymers, adhesives, sealants, 
paints and lacquers to improve the properties (e.g.  flexibility) of equipment (e.g.  cable 
insulation, rubber seals) in medical devices, including in vitro  diagnostic medical  
devices ; 
                                                 
4 http://ec.europa.eu/environment/waste/rohs_eee/adaptation_en.htm . 
5 For the f inal report of the study , see:  https://op.europa.eu/en/publication -detail/ -/publication/df0ab036 -8b52 -
11ea -812f-01aa75ed71a1/language -en/format -PDF/source -146143357 . 
6 Consultation period: 18 Marc h to 17 May 2019 ; https://rohs.exemptions.oeko.info/ . 
7 A list of the required administrative steps is available on the Comm ission website . The c urrent stage of the 
procedure can be viewed for each draft delegated act in the Interinstitutional Registry of Delegated Acts at 
https://webgate.ec.europa.eu/regdel/#/home . EN 3  EN  the market for recovered spare parts for medical equipment is a global one and spare 
parts are collected globally  for refurbishment and further distribution . Therefore,  it is 
not feasible to distinguish spare parts by their market of origin and to determine the 
concentration of phthalates in a non -destructive way. Furthermore , the existing spare 
parts provisions do not cover the global distribution of recovered spare parts for 
medical equipment ; 
 the substitution of the restricted phthalates has been assessed to be both scientifically 
and technically practicable . However , manufacturing new parts not containing the 
substances , rather than  reusing existing spare parts , produces  carbon dioxide 
emission s, introduc es heavy metals in to the market and  leads to the premature 
generation of hazardous and non -hazardous waste ; 
 overall, the total negative environmental, health and consumer safety impacts of 
substituti ng the four phthalates  in spare parts  are likely to outweigh the total benefits . 
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The evaluation results show that granting this exemption would not weaken the environmental 
and health protection afforded by the REACH Regulation.  
Furthermore, the exemption request meets at least one of the criteria in Artic le 5(1)(a) of the 
Directive : the total negative environmental, health and consumer safety impacts of 
substitution are likely to outweigh the total environmental, health and consumer safety 
benefits.  
The 7-year validity period for the exemption is not expec ted to have adverse impacts on 
innovation  and due to a long lifetime of MRI devices,  phthalate -containing spare parts will be 
needed in the following years . Therefore, the exemption should  be granted for a period of 7 
years . 
The proposed act grants an exemption from the substance restrictions in Annex II to the RoHS  
Directive, to be listed in its Annex IV  (on exemptions specific to medical devices and 
monitoring and control instruments) , for the use of DEHP , BBP, DBP and DIBP  in specific 
applications.  
The instrument is a delegated directive, as provided for by the RoHS Directive and meeting 
the relevant requirements of its Article 5(1)(a).  
The objective of the delegated directive is to contribute to the protection of human health and 
the environment , and harmonise  the provisions for the functioning of the internal 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 establi shed therein for the adaptation to 
scientific and technical progress  of its Annexes III and  IV. 
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 bis(2 -ethylhexyl) phthalate (DEHP), butyl benz yl 
phthalate  (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts 
recovered from and used for the repair or refurbishment of medical devices  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Un ion, 
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 that Directive. That restriction does not apply to certai n exempted 
applications listed in Annexes III and IV to that Directive.  
(2) The categories of electrical and electronic equipment to which Directive 2011/65/EU 
applies are listed in its Annex I.  
(3) By Commission Delegated Directive (EU) 2015/8632, bis(2 -ethylhexy l) phthalate 
(DEHP), benzyl butyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl 
phthalate (DIBP) were added to the list of restricted substances referred to in Annex II 
to Directive 2011/65/EU.  
(4) Commission Delegated Directive (EU) 2015/863 provide s that the restriction of 
DEHP, BBP, DBP and DIBP is not to apply to spare parts for the repair, the reuse, the 
updating of functionalities or upgrading of capacity of medical devices, including in 
vitro  medical devices, placed on the market before 22  July 2021.  
(5) On 17  July 2018 , the Commission received an application made in accordance with 
Article 5(3) of Directive 2011/65/EU  for an exemption to be listed in Annex IV to that 
Directive , for the use  of DEHP, BBP, DBP and DIBP in spare parts recovered from 
and used for the repair or refurbishment  of medical devices, including in vitro 
diagnostic  medical devices (‘the requested exemption’).  
(6) The evaluation of the exemption application concluded that t he total negative 
environmental and health impacts of substituting refurbished parts containing DEHP, 
BBP, DBP and DIBP with new substance -free refurbished parts are likely to outweigh 
the total environmental and health benefits. The evaluation included stakeholder 
consultations required by Article 5(6) of the  Directive 2011/65/EU. The comments 
                                                 
1 OJ L  174, 1.7.2011, p. 88 . 
2 Commission Delegated Directive (EU) 2015/863 of 31 March 2015 amending Annex II to Directive 
2011/65/EU of the European Parliament and of the Council as regards the list of restricted substances 
(OJ L 137, 4.6.2015, p. 10 ). EN 5  EN received during those consultations were made publicly available on a dedicated 
website.  
(7) In order to ensure a high level of protection for the environment , health  and consumer 
safety , reuse should take place in auditable  closed -loop business -to-business return 
systems and reuse of spare pa rts should be  notified to the customer. 
(8) The requested  exemption is consistent with Regulation (EC) No  1907/2006 of the 
European Parliament and of the Council  (REACH)3 and does not weaken  the 
environmental and health protection afforded by  it. 
(9) It is therefore appropriate to grant t he requested exemption by including the 
applications covered by it in Annex IV to Directive 2011/65/EU.  
(10) The requested exemption should be  grant ed for a duration of 7 years starting from [the 
date of the adoption of  this Directive] , in accordance with the second  subparagraph of 
Article  5(2) of Directive 2011/65/EU.  In view of the results of the ongoing efforts to 
find a reliable substitution, the du ration of the exemption is unlikely to have adverse 
impacts on innovation . 
(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 Direc tive. 
Article 2 
(1) Member States shall adopt and publish , by [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 
communicate the text of those provisions  to the Commission forthwith . 
They shall apply those provisions from [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 reference is to be made.  
(2) Member States shall communicate to the Commission the text of the main provisions of 
national law  that 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, Authorisation and Restriction of Chemicals (REACH) , establishing 
a European Chemicals Agen cy, 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/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 Article 4 
This Directive is addressed to the Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen