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 oxide in seal frit used for making window assemblies for certain l aser 
tubes  
(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 
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 RoH S 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 32 permits the use of lead oxide in seal frit used for making 
window assemblies for Argon and Krypton laser tubes . The Commission recei ved two 
application s for renewal of this exemption in January  2015 . While e xemption 32 had 21 July 
2016 as expiration date for categories 1 to 7 and 104, in line with the requirements of the 
                                                 
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 These categories are namely: 1. Large household appliances; 2. Small household appliances; 3. IT and 
telecommu nications equipment; 4. Consumer equipment; 5. Lighting equipment; 6. Electrical and  
EN 2  EN RoHS Directive  (Article 5(5), second 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 required technical and scientific assessment,  including an eight -week  online 
open -ended stakeholder consultation5 on the application. Two contributions were made to 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  in written form  as agreed during a previous meeting7. The experts agreed with 
the draft presented by the Commission, with a large majority of silent membe rs. 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 decisi on procedure followed 
alternative deadlines as per Article 5(5)8. The Council and the European Parliament were 
notified of all activities.  
The final report  highlighted in particular the following technical information and assessment : 
 Lead oxide -based mater ial in Argon and Krypton laser products provides a critical 
thermo -mechanically -stable and vacuum -tight seal between the optics and laser tube. 
Lead containing laser products are used as coherent light sources in a broad range of 
critical scientific and in dustrial applications, such as spectroscopy, microscopy and 
holography.  
 Currently, a substitution or elimination of lead in the application s concerned is still 
scientifically and technically impracticable . 
The evaluation results for categories 1 to 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 32 in 
Annex III. Since f or the applications concerned,  no reliable alternativ es are available today or 
are likely to come on the market soon, a renewal of the exemption with a  validity period until 
21 July 2021 is justified ; as reliable substitutes are not yet available, no negative 
socioeconomic impacts of substitution are to be a nticipated for this period.  The granted 
validity period is also not expected to have adverse impacts on innovation . For categories 
other than categories 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.  
                                                                                                                                                         
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/   
7 The c onsultations were carried out in written  form from 27 April until 18 May  2017.  
8 A list of  the required administrative  steps is available on the Commission website . Current stage of the 
procedure can be viewed for e ach 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 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 th e 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 field of el ectrical 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 oxide in seal frit used for making window assemblies for certain laser 
tubes  
(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 requires 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 Directive 2011/65/ EU. 
(2) The different categories of electrical and electronic equipment for which Directive 
2011/65/EU applies (categories 1 to 11) are listed in Annex I to that Directive.  
(3) Lead is a restricted substance listed in Annex II to Directive 2011/65/EU.  The use of 
lead oxide in seal frit used for making window assemblies for Argon and Krypton 
laser tubes  was, however, exempted from the restriction and is currently listed in entry 
32 of Annex III to that Directive. The expiry date of that exemption was, for 
categories 1 to 7 and 10, 21 July 2016 .  
(4) The Commission received an application for renewal of th at exemption before 
21 January  2015, in accordance with Article 5(5) of Directive 2011/65/EU.  The 
exemption remains  valid until a decision on that application has been adopted.  
(5) Lead containing laser products are used as coherent light sources in a broad range of 
critical scientific and industrial applications, such as spectroscopy, microscopy and 
holography.  Lead oxide -based m aterial in Argon and Krypton laser products provides 
a critical thermo -mechanically -stable and vacuum -tight seal between the optics and 
laser tube.  
(6) A substitution or elimination of lead  is still scientifically and technically impracticable  
for Argon an d Krypton laser tubes due to the lack of reliable substitutes. T he 
exemption does not weaken the environmental and health protection afforded by 
                                                 
1 OJ L 174, 1.7.2011, p. 88.   
EN 5  EN Regulation (EC) No 1907/2006 of the European Parliament and of the Council2. The 
exemption for the use of lead oxide in seal frit used for making window assemblies for 
Argon and Krypton laser tubes should therefore be renewed  for categories 1 to 7 and 
10. 
(7) Since , for the applications concerned, no reliable alternatives are available today or are 
likely to be available on the  market in the near future , the exemption for categories 1 
to 7 and 10 should be renewed for the maximum duration of five years until 21 July 
2021. 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 . 
(8) For categories other than 1 to 7 and 10 , 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 clarity, the dates of expiry should be added in Annex III to 
that Directive.  
(9) 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 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 th e 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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