EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2019) XXX  draft  
 
COMMISSION DELEGATED DIRECTIVE (EU) .../…  
of XXX  
amending, for the purposes of adapting to scientific and technical progress, Annex III to 
Directive  2011/65/EU of the European Parliament and of the Council as regards an 
exemption for bis(2 -ethylhexyl) phthalate (DEHP) in certain rubber components used in  
engine systems  
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
This Commission Delegated Directive amends, for the purpose of adapting to technical 
progress, Annex I II of 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 (RoHS  2) as regards an exemption for specific  applications containing 
bis(2 -ethylhexyl) phthalate (DEHP) . 
RoHS  2 restricts the use of certain hazardous substances in electrical and electronic 
equipment , as provided for in its Article 4.  It entered into force on 21 July 2011.  
The restricted substances  are listed in Annex II to RoHS  2. While the restriction s of lead, 
mercury, cadmium, hexavalent chromium, polybrominated biphenyls, and polybrominated 
diphenyl ethers are in force to date, the restriction s of bis(2 -ethylhexyl) phthalate (DEHP), 
butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), diisobutyl phthalate (DIBP) shall 
apply  from 22 July 2019  or later . Annexes III and IV to RoHS 2 list the materials and 
components of electrical and electronic equipment ( EEE) for specific applications exempted 
from the substance restriction of RoHS  2 Article 4(1).  
Article 5 makes provision for the adaptation to scientific and technical progress (inclusion,  
renewal, amendments and revoking  of exemptions) of Annexes III and IV. Pursuant to 
Article  5(1)(a), exemptions are to be included in Annexes III and IV  only if such inclusion 
does not weaken the environmental and health protection afforded by 
Regulation  (EC)  No 1907/20062 and where any of the following conditions is fulfi lled: 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 negative environmental, 
health and consumer safety impacts caused by substitution are likely to outweigh the total 
environmental, health and consumer safety benefits thereof.  
Furthermore, Article 5(1) provides that the European Commission (th e Commission) shall 
include materials and components of EEE for specific appli cations in the lists in Annexes  III 
and IV by means of individual delegated acts in accordance with Article  20. Article 5(3) and 
Annex V establish the procedure for submitting ap plications for granting, renewing, or 
revoking an exemption.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
Since the publication of RoHS 2 , the Commission has received numerous3 requests from 
economic operators, according to the provisi ons in Article 5(3) and Annex V, for both 
granting new and renewing existing exemptions.  
The Commission received a request  for a new  exemption to Annex III for use of DEHP in 
rubber parts such as O -rings, seals, vibration dampers, gaskets, hoses, grommets and cap -
plugs that are used in engine systems including exhausts and turbochargers that are designed 
                                                 
1 OJ L 174, 1.7.2011, p. 88.  
2 OJ L 396, 30.12.2006, p. 1. 
3 The list is given at: http://ec.europa.eu/environment/waste/rohs_eee/adaptation_en.htm   
EN 2  EN for use in equipment that is not designed solely for consumer use  on 29  June 2017 (request 
no. 201 7-6). The exemption was requested for category 114.  
With  a view to evaluat ing the request  for exemption , the Commission launched a study to 
carry out the required technical and scientific assessment,  including a six-week online 
open -ended stakeholder consultation5 on the application. One contribution was receiv ed 
during  the stakeholder consultation.  
The final report containing the assessment of the application was published6; stakeholders 
were notified.  
Subsequently, the Commission consulted the Member States expert group for delegated acts 
under RoHS 2  during an expert meeting on 29 October  2018. The experts agreed with the 
proposal  presented, with a large majority of silent members. All applicable  steps relating to 
exemptions from the substance restriction pursuant to Articles 5(3) to 5(7) have been 
performed.7 The Council and the European Parliament were notified of all activities.  
The final report  highlighted in particular the following technical information and assessment : 
 DEHP is added to rubber material as plasticiser in order to provide flexibilit y. The 
rubber components are used as flexible connections between parts of engine systems 
and assure prevention of leakage, sealing of engine parts and protection from 
vibration or dirt and fluids over the long lifetime of the engines . 
 While  substitution o f DEHP is in principle scientifically and technically viable in 
some rubber components, the reliability of these substitutes still needs to be ensured 
for the specific uses in the engine systems in scope of this requested exemption, 
where long lifetime and special requirements such as resistance to any contact 
material (e.g. fuel, lubricant oil, coolants, gases, dirt), temperature and vibration are 
required.  
The evaluation results for categor y 11 show the specific exemption would not weaken the 
environmental and health protection afforded by Regulation (EC) No  1907/2006 (REACH), in 
accordance with Article 5 of Directive 2011/65/EU.  Furthermore, at least one of the relevant 
criteria specified in Article 5(1)(a) is met by the exemption request : Since for the applications 
concerned,  no reliable alternatives are available today or are likely to come on the market 
soon, granting the exemption with the maximum validity period of five years , starting from 22 
July 20198, is justified . As reliable substitu tes are not yet available, no negative 
socioeconomic impacts of substitution are to be anticipated for this period . The granted 
validity period is also not expected to have adverse impacts on innovation .  
                                                 
4 The categories listed in Annex I of Directive 2011/65/EU are namely: 1. Large household appliances; 2. 
Small h ousehold appliances; 3. IT and telecommunications equipment; 4. Consumer equipment; 5. 
Lighting equipment; 6. Electrical and electronic tools; 7. Toys, leisure and sports equipment; 8. Medical 
devices; 9. Monitoring and control instruments including indust rial monitoring and control instruments; 
10. Automatic dispensers ; 11. Other EEE not covered by any of the categories above .  
5 Consultation period : from 20.10.2017 to 01.12.2017. 
6 https://publications.europa.eu/en/publication -detail/ -/publication/0814e920 -4c55 -11e9 -a8ed -
01aa75ed71a1/language -en. 
7 A list of  the required administrative  steps is available on the Commission website . Current 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 . 
8 Restrictions set out by Directive 2011/65/EU will become applicable to category 11 on 22 July 2019. 
The exemption validity period for category 11 is specified in  Article 5(2) of that Directive.   
EN 3  EN 3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The Delegate d Directive grants an exemption from the restri ctions in Article 4(1), to be listed 
in Annex III  of Directive  2011/65/EU, for the use of DEHP  in specific applications.  
The inst rument is a Delegated Directive, as provided for by Directive 2011/65/EU, and in 
particular meeting the relevant requirements of Article 5(1)(a) thereof.  
The objective of the Delegated Directive  is to contribute to the protection of human health and 
the environment and approximate the provisions for the fun ctioning of the internal market in 
the field of electrical and electronic equipment , by allowing the use of otherwise banned 
substances for specific applications, in line with the provisions and under the conditions of 
RoHS  2 and the therein established pr ocedure for the adaptation of the Annexes  III and IV  to 
scientific and technical progress.  
In accordance with the principle of proportionality, the measure does not go beyond what is 
necessary to achieve its objective.  
The proposal 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 III to 
Directive  2011/65/EU of the Europ ean Parliament and of the Council as regards an 
exemption for bis(2 -ethylhexyl) phthalate (DEHP) in certain rubber components used in 
engine systems  
(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 Par liament 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)(a) there of, 
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 requirement does not apply to the appl ications listed 
in Annex III to Directive 2011/65/EU.  
(2) The different categories of electrical and electronic equipment to which Directive 
2011/65/EU applies are listed in Annex I to that Directive.  
(3) Bis(2-ethylhexyl) phthalate (DEHP) is a restricted substance listed in Annex II to 
Directive 2011/65/EU. On 29 June 2017, t he 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 III  to that Directive , for the use of DEHP  in rubber parts such as O -
rings, seals, vibration dampers, gaskets, hoses, grommets and cap -plugs that are used 
in engine systems including exhausts and turbochargers that are designed for use in 
equipment that is not designed solely for consumer use  (“the r equested exemption”).  
(4) The evaluation of the requested exemption included stakeholder consultations in 
accordance with Article 5(7) of Directive 2011/65/EU.  
(5) DEHP is added to rubber material as plasticiser in order to provide flexibility. The 
rubber components are used as flexible connections between parts of engine systems 
and assure prevention of leakage, sealing of engine parts and protection from vibration 
or dirt and fluids over the lifetime of the engines.  
(6) Currently, there are no DEHP -free a lternatives available on the market which would 
provide sufficient level of reliability for application s in engines  where long life and 
special properties  such as resistance to any contact material (e.g. fuel, lubricant oil, 
coolants, gases, or dirt), temp erature and vibration are required.  
                                                 
1 OJ L 174, 1.7.2011, p. 88.   
EN 5  EN (7) Due to the lack of reliable alternatives , a substitution or elimination of DEHP  is still 
scientifically and technically impracticable  for certain  rubber parts used in engine 
systems . The requested exemption is consistent with Regulation (EC) No 1907/2006 
of the European Parliament and of the Council2 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 III to Directive 2011/65/EU with respect to 
electrical and electronic equipment of category 11 of Annex I to Directive 
2011/65/EU.  
(9) The exemption should be granted  for the maximum validity period  of 5 years  starting 
from 22 July 2019, in accordance with Article 4(3) and the first 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 duration of th e 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 III 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 12th 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 
forthwith  communicate to the Commission the text of those provisions.  
They shall apply those provisions from  [the last day of the 12th 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 pr ovisions 
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.  
                                                 
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).   
EN 6  EN Done at Brussels,  
 For the Commission  
 The President  
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