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) in plastic components in 
magnetic resonance imaging (MRI) detector coils  
(Text with EEA relevance)   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 RoHS  Directive) as regards an exemption for specific 
applications containing bis(2 -ethylhexyl) phthalate (DEHP).  
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 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 phtha late (DBP) and diisobutyl phthalate  (DIBP). DEHP, 
BBP, DBP and DIBP were  added to the list by Commission Delegated Directive 
(EU)  2015/8632 and will be prohibited in medical devices covered by the RoHS Directive 
from  22 July 2021 .  
Annexes III and IV to the RoHS Directive list the materials and components of EEE for 
specific applications exempted from the substance restrictions in its Article  4(1).  Article  5 
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 
conditi ons 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.  
Decisions on exemptions, and their dur ation, 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 pursuant to Article  20. Article  5(3) and Annex  V establish the 
procedure for submitting exemption applications.  
                                                 
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 2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The Commission receives numerous requests4 from economic operators to grant or renew 
exemptions under t he RoHS Directive ( Article 5(3) and Annex V ). 
On 12  September  2018 , the Commission received an application for a new exemption for the 
use of DEHP in polyvinylchloride (PVC) for coil -cable strain -relief devices in magnetic 
resonance imaging (MRI) scanner s. 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 , involved an 8-week 
online stakeholder c onsultation , during which n o contributions were received . Information 
concerning the consultation was provided on the project website6.  
On 2 October  2019 , the Commission received a similar request for a new exemption  for the 
use of DEHP in plastic compone nts in MRI detector coils.  Due to the similarity of the two 
requests and as additional information was required  on the availability of substitutes and 
socio -economic aspects, it launched an in -depth study in November 2019, which concluded in 
June 20207. 
In an 8 -week  public consultation , stakeholders were informed about new steps and 
information was provided on the project website8. No contributions were received during the 
consultation , but MRI manufacturers other than the applicant were interviewed as part  of the 
information -gathering exercise.  
The Commission consulted the Member States ’ expert group for delegated acts under the 
RoHS Directive on 23 February 2021.  Some experts expressed agreement with  the drafts 
presented, with a large group remaining silen t. The Commission has taken a ll necessary steps 
relating to exemptions from the substance restriction pursuant to Article  5(3) to  (7)9. It 
notified the Council and the European Parliament of all activities  in this context . 
The technical and scientific asse ssment report s highlighted that:  
 the first request concerned the use of DEHP in PVC cable strain reliefs in MRI 
detector coils. The second  had a wider coverage and concern ed the use of DEHP in 
flexible polymers used in plastic components in MRI detector coils . The evaluation 
found that a joint exemption would be appropriate ; 
 for many MRI scanners , there are currently no DEHP -free coils available . However , at 
least one manufacturer provide s DEHP -free MRI components ; 
 the development of alternatives and substitutes  will require  more time to ensure 
appropriate and broad availability ; 
 given  the present lack of sufficient appropriate alternative  technologies  and substitutes , 
not granting an  exemption would probably  result in a supply shortage for health 
services, which depend on original  MRI coils.  This may result in health impacts for 
                                                 
4 http://ec.europa.eu/environment/waste/rohs_eee/adaptation_en.htm  
5 For the f inal report of the study (Pack 17) , see:  https://op.europa.eu/en/publication -detail/ -
/publication/df0ab036 -8b52 -11ea -812f-01aa75ed71a1/language -en/format -PDF/source -146143357  
6 Consultation period:  18 March to 17 May 2019 ; https://rohs.exemptions.oeko.info/  
7 For the f inal report of the study (Pack 20) , see:  https://op.europa.eu/en/publication -detail/ -
/publication/185e9d5b -d5fc-11ea -adf7-01aa75ed71a1/language -en/format -PDF/source -146144567  
8 Consultation period: 10 January to 20 February 2020 ; https://rohs.exemptions.oeko.info/  
9 A list of the required administrative steps is available on the Commission 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 many patients in the EU  linked to the lack of relevant  diagnosis and treatment 
facilit ies. 
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
While DEHP in articles is restricted by entry  51 in Annex  XVII to the REACH  Regulation, 
EEE within the scope of the RoHS Directive is exempted from this restriction. The evaluation 
results show that granting the exemption would  not weaken the environmental an d health 
protection afforded by REACH, thereby satisfying the condition in  Article  5 of the Directive.  
Furthermore, the exemption request s meet  at least one of the criteria in Article 5(1)(a) of the 
Directive : the reliability of substitutes is not sufficie ntly ensured and the total negative 
environmental, health and consumer safety impacts of substitution are likely to outweigh the 
total environmental, health and consumer safety benefits.  
In view of the manufacturers ’ ongoing efforts to find a reliable and widely available 
alternative , the duration of the exemption  until 1 January 2024 , as requested  is unlikely to 
have adverse impacts on innovation.  Therefore, the exemption  should  be granted  for the 
requested duration . 
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 in specific applica tions.  
The inst rument is a delegated d irective, as provided for in the RoHS  Directive and meeting 
the relevant requirements of its Article 5(1)(a).  
The objective of the delegated d irective 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 established 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) in plastic components in  
magnetic resonance imaging (MRI) detector coils  
(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 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 e Directive. That restriction does not apply to certain exempted 
applications listed in Annexes III and IV to the Directive.  
(2) The categories of elect rical and electronic equipment to which Directive 2011/65/EU 
applies are listed in its Annex I.  
(3) Bis(2 -ethylhexyl)  phthalate (DEHP) is a restricted substance listed in Annex  II to 
Directive  2011/65/EU , as amended by  Commission Delegated Directive 
(EU)  2015/ 8632. DEHP is not to  be used, from 22 July 2021, in medical devices, 
including in vitro  medical devices above a maximum concentration value of 0.1% 
tolerated by weight in homogeneous materials . 
(4) On 12 September 2018 and 2  October  2019, the Commission receiv ed requests  for a 
new exemption , to be included  in Annex IV  to Directive 2011/65/EU , for the use o f 
DEHP  in plastic components in magnetic resonance imaging (MRI) detector coils  
(‘the requested exemption’)  
(5) Two technical and scientific assessment stud ies were carried out  to evaluate the 
exemption requests3 4. The first covered the first application received . Due to the 
similarity of the second application , the second evaluated  the two requests together. 
The evaluation of the applications , which took into a ccount the availability  of 
                                                 
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 ). 
3 For the f inal report of the study (Pack 17) , see:  https://op.europa.eu/en/publication -detail/ -
/publication/df0ab036 -8b52 -11ea -812f-01aa75ed71a1/language -en/format -PDF/source -146143357 . 
4 For the f inal report of the study (Pack 20) , see:  https://op.europa.eu/en/publication -detail/ -
/publication/185e9d5b -d5fc-11ea -adf7-01aa75ed71a1/language -en/format -PDF/source -146144567 . 
 EN 5  EN technically practicable and reliable substitutes and the socioeconomic impact of 
substitution , concluded that no suitable alternatives  to DEHP are sufficiently available 
on the market  and that not granting the exemption is likely to result in total negative 
environmental, health and consumer safety impacts caused by substitution , which  
outweigh the benefits thereof . The evaluation included stakeholder consultations as 
required by  Artic le 5(7) of Directive  2011/65/EU . The comments received during 
those consultations were made publicly available on a dedicated website.  
(6) The requested  exemption is consistent with Regulation (EC)  No 1907/2006 of the 
European Parliament and of the Council5 and thus does not weaken the environmental 
and health protection afforded by  it.  
(7) It is , therefore , appropriate to grant the requested exemption  by including the 
applications covered by it in Annex IV to Directive 2011/65/EU . 
(8) To ensure that compatible plastic components for MRI coil detectors for health 
services are widely available on the Union market and to allow time for the 
develop ment of  suitable and widely available alternatives, the requested exemption 
should be granted u ntil 1 January 2024, in accordance with Article 5(2), second 
subparagraph, of Directive 2011/65/EU. In view of the results of the ongoing efforts to 
find a reliable substitution, the duration of the exemption is unlikely to have adverse 
impacts on innovati on. 
(9) 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 [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 Comm ission 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 accompa nied 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.  
                                                 
5 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 1999/45/EC and repealing Council 
Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Coun cil 
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 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 B russels,  
 For the Commission  
 Ursula VON DER LEYEN  
 The President