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 lead in solders and termination finishes used in certain hand -held 
comb ustion engines  
(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 
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 applicati ons 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 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 current Annex III exemption 41 permits the use of lead in solders and termination 
finishes of electrical and electronic components and finishes of printed circuit boards used in 
ignition modules and other electrical and electronic engine control systems, which for 
technical reasons must be mounted directly on or in the crankcase or cylinder of hand -held 
combustion engines (classes SH:1, SH:2, SH:3 of Directive 97/68/EC of the Euro pean 
Parliament and of the Council) . The Commission received one application  for renewal of this 
                                                 
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 exemption in June 2017  for categories 6 and 11 . While exemption 41 had 31 December  2018 
as expiration date for categories 1 to 7 and 10, in line with the requi rements of the RoHS 
Directive (Article 5(5), second subparagraph), it continues to apply until a decision on the 
renewal application is taken by the Commission.4  
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. 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 29 October  2018. The experts agreed with the 
proposal  presented, with a large majority of absent or 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 a ctivities.  
The final report  highlighted in particular the following technical information and assessment : 
 Lead is a common alloying element in solder material to control the melting point. 
The applicant  has successfully tested alternative materials to replace the restricted 
substance. However,  additional time is needed to confirm the reliability  of the lead -
free products . 
 Currently, the reliability of lead-free alternatives available on the market is still to be 
confirmed in further testing .  
The evaluation results for categor ies 1 to 7, 10 and 11 show that 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 f or the applications concerned,  no reliable alternatives are available 
today, granting the exemption w ith a validity period of 24 months after the publication of the 
delegated directive in the Official Journal  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 .  
For categories 8 and 9 , the existing exemption remains as per the validity periods set out in 
Article 5(2) .  
 
                                                 
4 The categories listed in Annex I of Directive 2011/65/EU are namely: 1. Large household appliances; 2. 
Small household appliances; 3. IT and telecommunications equipment; 4. Consumer equipm ent; 5. 
Lighting equipment; 6. Electrical and electronic tools; 7. Toys, leisure and sports equipment; 8. Medical 
devices; 9. Monitoring and control instruments including industrial monitoring and control instruments; 
10. Automatic dispensers ; 11. Other EE E 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/33a336f0 -e0ef-11e8 -b690 -
01aa75ed71a1/language -en/format -PDF/source -85019010  . 
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 . EN 3  EN 3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The Delegated Di rective 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 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 lead in solders and termination finishes used in certain hand -held 
combustion engines  
(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) ther eof, 
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 the exempte d applications 
listed in Annex III to Directive 2011/65/EU.  
(2) The categories of electrical and electronic equipment to 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.  
(4) By Delegated Directive (EU) 2014/72/EU2, the Commission granted an exemption for 
the use of lead in solders and termination finishes of electrical and electronic 
components and finishes of printed circuit boards used in ignition modules and ot her 
electrical and electronic engine control systems, which for technical reasons must be 
mounted directly on or in the crankcase or cylinder of hand -held combustion engines 
(classes SH:1, SH:2, SH:3 of Directive 97/68/EC of the European Parliament and of 
the Council3) (“the exemption”)  by including those applications in Annex III to 
Directive 2011/65/EU. The exemption was to expire for categories 1 to 7 and 10  on 31 
                                                 
1 OJ L 174, 1.7.2011, p. 88.  
2 Commission Delegated Directive 2014/72/EU of 13 March 2014 amending, for the purposes of 
adapting to technical prog ress, Annex III to Directive 2011/65/EU of the European Parliament and of 
the Council as regards an exemption for lead in solders and termination finishes of electrical and 
electronic components and finishes of printed circuit boards used in ignition modul es and other 
electrical and electronic engine control systems (OJ L 148, 20.5.2014, p. 78).  
3 Directive 97/68/EC of the European Parliament and of the Council of 16 December 1997 on the 
approximation of the laws of the Member States relating to measures ag ainst the emission of gaseous 
and particulate pollutants from internal combustion engines to be installed in non -road mobile 
machinery (OJ L 59, 27.2.1998, p.1). Directive 97/68/EC has been repealed by Regulation (EU) 
2016/1628 of the European Parliament a nd of the Council of 14 September 2016 on requirements 
relating to gaseous and particulate pollutant emission limits and type -approval for internal combustion 
engines for non -road mobile machinery, amending Regulations (EU) No 1024/2012 and (EU) No 
167/201 3, and amending and repealing Directive 97/68/EC (OJ L 252, 16.9.2016, p. 53).  EN 5  EN December 2018, in accordance with the second subparagraph of Article 5(2) of that 
Directive.  
(5) The Commission received an application for renewal of th e exemption for categories 6 
and 11 (“the renewal request”) on 30  June 2017 , that is within the time limit laid down 
in Article 5(5) of Directive 2011/65/EU. In accordance with that provisi on, t he 
exemption remains valid until a decision on the renewal request has been adopted.  
(6) The evaluation of the renewal request included stakeholder consultations in 
accordance with Article 5(7) of Directive 2011/65/EU.  
(7) Lead is a common alloying element in  solder material to control the melting point. 
Alternative materials to replace the restricted substance  have been  successfully tested . 
However,  additional time is needed to confirm the reliability  of the lead -free products . 
(8) Currently, there are no lead -free alternatives available on the market which would 
provide sufficient level of reliability for the applications  covered by the exemption .  
(9) Due to the lack of reliable alternatives , a substitution or elimination of lead  is currently 
scientifically and tech nically impracticable  for certain  hand -held combustion engines . 
It is, therefore, appropriate, to renew the exemption. The renewal  of the 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.  
(10) The exemption for categories 1  to 7, 10 and 11  should be renewed  until [the last day of 
the 24th month after the publication of th is Directive in the Official Journal] , 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 .  
(11) For categories 8 and 9 , the existing exemption remains valid as per the validity periods 
set out in the second subparagraph of Article 5(2) of Directive 2011/65/EU . For 
reasons of legal clarity, the dates of expiry should be specified in Annex III to that 
Directive.  
(12) 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.  
                                                 
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) and 
establishing a European Chemicals Agency (OJ L 396, 30.12.2006, p. 1).  EN 6  EN 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 accom panied 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 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.  
Done a t Brussels,  
 For the Commission  
 The President  
 […]