EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2018) 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 lead in bearings and bushes applied in certain non -road professional us e 
equipment  
(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 i  
n electrical and electronic equipment  (recast)1 (RoHS  2) as regards an exemption for specifi c 
applications containing lead. 
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 restricti on 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 An nexes 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 fulfilled: their 
elimination or substitution via design changes or materi als 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 imp acts 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 (the Commission) shall 
include materials and components of EEE for spec ific 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 applications 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 lead in 
bearings and bushes of diesel or gaseous fuel powered internal combustion engines applied in 
non-road professional use equipment in July 2015  (request no. 201 6-1). The exemption was 
requested for category 114.  
                                                 
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  
4 The categories listed in Annex I of Directive 2011/65/EU are namel y: 1. Large household appliances; 2. 
Small household appliances; 3. IT and telecommunications equipment; 4. Consumer equipment; 5.  
EN 2  EN 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 an eight -week online 
open -ended stakeholder c onsultation5 on the application. No contribution s were  received 
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 22 September 2017 . The experts agreed with the 
proposal  presented by the Commission, 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 : 
 Lead containing bearings and bushes are necessary to achieve satisfactory reliability  
in large size engines and those operating  in harsh or  demanding environments  to be 
used in  professional use non -road equipment . Such bearings and bushes are used for 
exam ple in mobile air compressors, mobile welding equipment or cranes.  
 Currently, there are no  lead-free alternatives available on the market which would 
provide sufficient level of reliability in terms of  seizure resistance, conformability, 
embedability and d ebris resistance for application areas of professional use non -road 
equipment  engines . Therefore, substitution or elimination of lead  is still scientifically 
and technically impracticable  for applications  concerned .  
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 Ar ticle 5(1)(a) is met by the exemption request : Since f or 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 substitutes 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 . In order to avoid 
overlapping scopes of exemptions  within Annex III, the proposed wording clarifies that  
applications covered by exemption 6(c) are excluded from the newly granted exemption . 
 
                                                                                                                                                         
Lighting equipment; 6. Electrical and electronic tools; 7. Toys, leisure and sports equipment; 8. Medical 
devices; 9. Monitor ing and control instruments including industrial monitoring and control instruments; 
10. Automatic dispensers ; 11. Other EEE not covered by any of the categories above .  
5 Consulta tion period : from 14.03.2015 to 09.05.2016. 
6 https://publications.europa.eu/en/publication -detail/ -/publication/44a95380 -f4e3-11e6 -8a35 -
01aa75ed71a1 . 
7 A list of  the required administrative  steps is available on the Comm ission 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 Category 11 enters in scope of Directive 2011/65/EU on 22 July 2019. The validity period for category 
11 is specified in  Article 1 (4) (a) of  Directive (EU) 2017/2102 of the European Parliament and of the 
Council of 15 November 2017  amending RoHS 2.   
EN 3  EN 3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The Delegated 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 lead 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 functioning of the internal market in 
the fi eld 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 procedure 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 European Parliament and of the Council as regards an 
exemption for lead in bearings and bushes applied in certain non -road professional use 
equipment  
(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) thereof,  
Whereas:  
(1) Directive 2011/65/EU requi res Member States to ensure that electrical and electronic 
equipment placed on the market does not contain certain hazardous substances  listed 
in Annex II to that Directive.  That requirement does not apply to the applications 
listed in Annex III to Directi ve 2011/65/EU.  
(2) The different categories of electrical and electronic equipment for which Directive 
2011/65/EU applies are listed in Annex I to that Directive.  
(3) Lead is a restricted substance listed in Annex II to Directive 2011/65/EU. The 
Commission  received, i n accordance with Article 5( 3) of Directive 2011/65/EU , in 
July 2015  an application for granting a n exemption  for category 11, to be listed in 
Annex III,  for use of lead in bearings and bushes of diesel or gaseous fuel powered 
internal combusti on engines applied in non -road professional use equipment .  
(4) Lead containing bearings and bushes are necessary to achieve satisfactory reliability  in 
terms of  seizure resistance, conformability, embedability and debris resistance in large 
size engines a nd those operating  in harsh or  demanding environments  to be used in  
professional use non -road equipment , such as mobile air compressors, mobile welding 
equipment and mobile cranes . 
(5) Currently, there are no lead -free alternatives available on the market which would 
provide sufficient level of reliability for application areas of professional use non -road 
equipment  engines .  
(6) Due to the lack of reliable substitutes, a  substitution or elimination of lead  is 
scientifically and technically impracticable  for certain  professional use non -road 
equipment  engines . The exemption is consistent with Regulation (EC) No 1907/2006 
                                                 
1 OJ L 174, 1.7.2011, p. 88.   
EN 5  EN of the European Parliament and of the Council2 and thus  does not weaken the 
environmental and health protection afforded by  it. The exem ption for the use of lead 
in bearings and bushes of certain diesel or gaseous fuel powered internal combustion 
engines applied in non -road professional use equipment should therefore be granted , 
adding  a new entry 42 to Annex III to Directive 2011/65/EU . To avoid overlapping 
scopes of exemptions  within Annex III and to ensure legal clarity , it should be added 
that applications covered by e ntry 6(c) of Annex III  are excluded from the new entry  
42 to Annex III to Directive 2011/65/EU . 
(7) Since , for the applications concerned , no reliable alternatives are yet available on the 
market or are likely to be available on the market in the near future, the exemption for 
category  11 of Annex I to Directive 2011/65/EU should be granted  for the maximum 
validity period  of five years  starting from 22 July 2019, which is the date that category 
11 enters in to the scope of Article 4(1) 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 .  
(8) 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 21 July 2019  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  22 July 2019 . 
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 deter mine 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 twen tieth 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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