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 ion -selective electrode s 
for analysing human body fluids and/or in dialysate fluids   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) . 
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 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). DEHP was 
added to the list by Commission De legated 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 Directiv e 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  
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 substi tutes 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, 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  the RoHS  Directive  (Article 5(3) and Annex V ). 
On 17  July 2018 , the Commission received a request for a  new exemption in Annex  IV to 
allow the placing  on the market  of medical devices containing >0.1% DEHP by weight in 
homogeneous materials in  specific applications . The request  concerns an exemption for the 
use of DEHP in ion -selective electrodes applied in point of care analysis  for medical devices . 
In November 2018 , in order to evaluat e the application for this new exemption, the 
Commission launched a study5 to carry out the re quired technical and scientific assessment . 
The study, which was concluded in 2020 , involved  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 . Some experts expressed agreement with the drafts 
presented, with a large group remaining silent. The Commission has taken a ll necess ary 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 that:  
 DEHP  is used in membrane solvent  for ion -selective electrode constituents in analysers  
that allow the practicable and quick ‘point of care analysis ’ of ionic substances present 
in human body fluids and/or in dialysate fluids ; 
 it would be technic ally feasible  to substitut e the membrane solvent , but current 
alternatives are not perform ing well and may inter alia  have adverse socio -economic 
impacts ; 
 not granting the exemption would result in  the early obsolescence of around  500 t of 
point of care analysers  that depend on ion -selective electrodes . The environmental 
benefit of not placing DEHP membrane solvents  on the market  is relatively limited, as 
spent ion -selective electrodes are medical waste and ultimately incinerat ed. The  DEHP 
would  not be returned to the material cycle ; 
 not granting an exemption would also place  a high financial and organisational burden 
on healthcare facilities as a result of  having to replac e the point of care analysers . This 
could prevent or delay  analyses and the health service might h ave to finance unplanned 
new equipment , resulting in unintended indirect health impacts ; 
 overall, the total negative environmental  and health  impacts of substituti ng DEHP in 
ion-selective electrode constituents are likely to outweigh the total benefits ; 
 in the light of  the average lifetime of ion -selective electrode point of care analysers and 
the likely  time required  for switching to a non -DEHP market , the maximum 7-year 
                                                 
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/fo rmat-PDF/source -146143357 . 
6 Consultation period: 18 March to 17 May 2019 ; https://rohs.exemptions.oeko.info/ . 
7 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 exemption period , as laid down in Article 5(2) of the RoHS Directive , is appropriate 
for these specific applications.  
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 th at restriction. The evaluation 
results show that granting the  exemption would not weaken the environmental and health 
protection afforded by REACH, thereby satisfying the condition in  Article  5 of the Directive.  
Furthermore, the exemption request meets at least one of the criteria in Article  5(1)(a) of the 
Directive : overall, the reliability of substitutes is currently not sufficiently ensured and the 
total negative environmental, health and consumer safety impacts caused by substitution are 
likely to outweig h the total environmental, health and consumer safety benefits thereof.  
The validity period of the exemption is not expected to have adverse impacts on innovation.  
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 in specific applications.  
The instrument is a delegated directive, as provided for in 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  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 ion -selective electrodes 
for analysing hu man body fluids and/or in dialysate fluids  
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 ma rket does not contain the hazardous substances listed in 
Annex  II to the Directive. That restriction does not apply to certain exempted 
applications listed in Annexes III and IV to the Directive.  
(2) The categories of electrical and electronic equipment to whi ch Directive 2011/65/EU 
applies are listed in its Annex I . 
(3) Pursuant to Commission Delegated Directive (EU) 2015/8632, bis(2 -
ethylhexyl)  phthalate (DEHP)  is a restricted substance listed in Annex II to Directive 
2011/65/EU and its use is to be prohibited, f rom 22 July 2021, in medical devices, 
including in vitro  medical devices above a m aximum concentration value of 0. 1% 
tolerated by weight in homogeneous materials.  
(4) On 17 July 2018, the Commission received an application made i n 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 in ion selective electrodes for analysing human body 
fluids and/or in dialysate fluids  (‘the requested exemption ’). 
(5) DEHP is used in membrane solvent of ion selective electrodes applied in point of care 
analysers which  help to measure the concentration of ionic substances in human body 
fluids and/or in dialysate fluids.  
(6) A technical and scientific assessment study was car ried out to evaluate the exemption 
application3. The evaluation of the application concluded that alternatives to DEHP are 
currently not sufficiently reliable and that the substitution of DEHP in specific 
applications would result in negative environmental  and health impacts that outweigh 
its benefits. The evaluation included stakeholder consultations in accordance with 
                                                 
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 l ist of 
restricted substances (OJ L 137, 4.6.2015, p. 10).  
3 Study to assess three e xemption requests relating to Annex IV to Directive 2011/65/EU (Pack 17) . EN 5  EN Article  5(7) of Directive 2011/65/EU. The comments received during those 
consultations were made publicly ava ilable on a dedicated website.  
(7) The requested exemption is consistent with Regulation (EC)  No 1907/2006 of the 
European Parliament and of the Council4 and thus does not weaken the environmental 
and health protection afforded by it.  
(8) It is therefore appropriate to grant the requested exemption by including the 
applications covered by it in Annex IV to Directive 2011/65/EU .  
(9) To provide efficient technical equipment for health services and to allow time for the 
development of suitable alternatives, the requested exemption should be grant ed for a 
duration of 7 years starting  from  [the date of adoption of this Directive] , 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 innovation .  
(10) 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 5 th 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 forewith . 
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 mai n 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 . 
                                                 
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), 
establishi ng 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/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 Direct ive is addressed to the Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen