EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2017) 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 as an alloying element in steel  
(Text with EEA relevance)   EN 2   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 e lectronic 
equipment  (recast)1 (RoHS  2) as regards an exemption for specific 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 r estriction 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 e lectronic 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 followin g conditions is fulfilled: 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 substi tutes 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 Eu ropean Commission (the 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 proced ure 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 current  Annex III exemption 6(a) permits the use of lead as an alloying element in steel 
for machining purposes and in galvanised steel containing up to 0 .35 % lead by weight . The 
Commission received three  application s for renewal of this exemption in December  2014 and 
January  2015 . While e xemption 6(a) had 21 July 2016  as expir ation date  for categories 1 to 7 
and 104, in line with the requirements of the RoHS Directive  (Article 5(5), second 
                                                 
1 OJ L 174, 1.7.2011, p. 88.  
2 OJ L 396, 30.12.2006, p. 1. 
3 The l ist is given at: http://ec.europa.eu/environment/waste/rohs_eee/adaptation_en.htm . 
4 These categories are namely: 1. Large household appliances; 2. Small household appliances; 3. IT and 
telecommunications equipment; 4. Consumer equipment; 5. Lighting equipment; 6. Electrical and EN 3   EN subparagraph ), it continues to apply until a decision on the renewal application is taken by the  
Commission.  
With a view to evaluat ing the application  for exemption , the Commission launched a study to 
carry out the requ ired technical and scientific assessment,  including an eight -week online 
open -ended stakeholder consultation5 on the application. Six contributions were made to the 
stakeholder consultation.  
The final report containing the assessment of the application wa s published6; stakeholders 
were notified.  
Subsequently, the Commission consulted the Member States expert group for delegated acts 
under RoHS 2  during an expert meeting on 15 December 2016, which also involved 
presentations from the applicants and stakehol ders most concerned.  The experts  agreed  with 
the draft presented by the Commission , with a large majority of absent or silent members . All 
necessary steps relating to exemptions from the substance restriction pursuant to Article s 5(3) 
to 5(7) have been performed. Due to the large amount of simultaneous exemption requests 
and connected administrative requirements , the Commission decision procedure followed 
alternative deadlines as per Article  5(5). The Council and the European Parliament wer e 
notified of all activities.   
The final report  highlighted in particular the following technical information  and assessment : 
 Lead is added to steel as a machinability enhancer for industrial production. It has 
a lubrication effect that eases deep drilling  and high speed operations  and provides 
a good hot workability for the production of free cutting steels . The free cutting steel 
market is characterised by a highly complex supply chain.  
 Currently, substitution via lead -free steel is scientifically or tech nically practicable 
only for very specific applications. Substitution with bismuth -containing steel might 
not be reliable and there might  be a risk of negative environmental impacts.  
 Galvanisation is the process of applying a protective zinc coating to steel in order to 
prevent corrosion. The most common form of galvanisation is hot dip galvanisation, 
where iron or steel articles are galvanised by dipping in a molten bath of zinc or zinc -
alloy; a small amount of lead tends  to be present in the zinc bath.  Hence, lead in 
galvanised steel is mostly unintentionally present as an impurity related to the use of 
recycled zinc.  The intentional addition of lead to the galvanizing bath to adjust the 
viscosity and reach optimal drainage of excess zinc  is used  in a limited number of 
applications and  is rapidly declining due to technical innovation .  
 Lead is still required only in batch hot dip galvanised steel , and not in all types of 
galvanised steel , as the presence of lead in the continuous galvanizing process is 
sufficiently low to meet t he default requirement of 0.1% lead  in homogeneous 
material . Furthermore, a lower threshold for lead concentration of 0.2 % lead by 
weight  is recommended for batch hot dip galvanised steel.  
The evaluation results for categories 1 t o 7 and 10 show that at least one of the relevant 
criteria specified in Article 5(1)(a) is met by the exemption request relating to entry 6(a) in 
                                                                                                                                                         
electronic tools; 7. Toys, leisure and sports equipment; 10. Automatic dispensers. EEE c ategories are 
listed  in Annex I  to the RoHS  Directive . 
5 Consultation period : from 21.08.2015 to 16.10.2015 . 
6 https://bookshop. europa.eu/en/assistance -to-the-commission -on-technological -socio -economic -and-
cost-benefit -assessment -related -to-exemptions -from -the-substance -restrictions -in-electrical -and-
electronic -equipment -pbKH0416554/ . EN 4   EN Annex III. Since for the applications concerned, no sufficiently reliable alternatives are 
available today or are likely to come on the market soon , and in case of hot dip galvanised 
steel, the lead content results from impurities  from recycled zinc , a validity period until 21 
July 2021  is justified for both application s; 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 , while a 
shorter period could gene rate unnecessary administrative burden for industry . Furthermore , 
the existing wording of the exemption has been amended to include only batch hot dip 
galvanised steel and to determine a lower threshold for lead concentration .  
For categories other than ca tegories 1 to 7 and 10, the existing exemption remains as per the 
validity periods set out in Article 5(2) . The specific exemption does 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.  
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 an d 
the environment and approximate the provisions for the functioning 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 u nder 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 5   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 as an alloying element in steel  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having reg ard 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 equipm ent7 and in particular Article 5(1)(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 lead. 
(2) Point 6(a) of Annex III to Directive 2011/65/EU exempted the use of lead as an 
alloying element in steel for machining purposes and in galvani sed steel containing up 
to 0.35 % lead by weight  until 21 July 2016 . The Commission received an application 
for renewal of this exemption  in relation to categorie s 1 to 7 and 10  before 
21 January  2015 , in accordance with Article 5(5) of Directive 2011/65/EU . 
(3) Lead is added to steel as a machinability enhancer for industrial production. It has 
a lubrication effect that eases deep drilling and high speed operation s. Galvanisation is 
the process of applying a protective zinc coating to steel in order to prevent corrosion.  
(4) Though lead -free steel is available for some specific applications , the substitution in 
the remaining applications is currently scientificall y and technically impracticable . A 
further narrowing of the scope of the exemption has proven to be currently not feasible 
due to the high complexity of the supply chain.  
(5) Among galvanised steel s, lead is still necessary only in batch hot dip galvanised steel 
and in a lower concentration due to progress in technology . 
(6) Since for the applications concerned  in categories 1 to 7 and 10 , no sufficiently 
reliable alternatives are available today or are likely to be available on  the market in 
the near future , and in case of hot dip galvanised steel, the lead content results from 
impurities from recycled zinc , validity period until 21 July 2021 is justified for both 
application , while a shorter period could generate unnecessary adminis trative burden  
for the industry . For categories other than categories 1 to 7 and 10, the existing 
exemption  is valid  as per the validity periods set out in  the second subparagraph of  
Article 5(2)  of Directive 2011/65/EU . 
(7) Directive 2011/65/EU should therefore be amended accordingly,   
                                                 
7 OJ L 174, 1.7.2011, p. 88.  EN 6   EN  
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 th ose 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 provisions 
of national law which they adopt in the field covered by this Direc tive. 
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 Brussels,  
 For the Commission  
 The President  
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