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 IV to 
Directive  2011/65/EU of the European Parliament and of the Council as regards an 
exemption for lead in platinized platinum electrodes used for certain conductivity 
measurements  
(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 IV 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 currently restricted substanc es as listed in Annex II to RoHS  2 are the following: lead, 
mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB), polybrominated 
diphenyl ethers (PBDE), bis(2 -ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), 
dibutyl phthalate (D BP) and diisobutyl phthalate (DIBP). 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 provi sion 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 fulfilled: their 
elimination or substitution via design changes or materials and components which do not 
require any of t he 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 outwei gh 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 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 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 IV exemption 37 permits t he use of lead in platinized platinum electrodes 
used for conductivity measurements  where certain conditions apply . The Commission 
received one application  for renewal of this exemption in June 2017 . While exemption 37 had 
31 December  2018 as expiration date for categories 8 and 9 , in line with the requirements of 
                                                 
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 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 stakehol der 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 activities.  
The final report  highlighted in particular the following technical information and assessment : 
 Lead -containing p latinized platinum electrodes are used in specialised instruments 
for measurements which require certain measurement qualities such as wide range, 
high accuracy,  or high reliability for high c oncentration of acid and alkali. The 
electrodes are  applied among others in electrical conductivity meters used for 
inspecting and  testing  of water  (river waters , seawater, drinking water, industrial 
effluents  etc.). 
 Currently, a substitution or elimination of lead in the applications concerned is still 
scientifically and technically impracticable.  
The evaluation results for categor ies 8 and 9 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 f or the 
applications concerned,  no reliable alternatives are available today  or are likely to come on 
the market soon, a renewal of the exemption for the maximum period of seven years unti l 31 
December 2025 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 .  
 
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 I V of Directive  2011/65/EU, for the use of lead in specific applications.  
                                                 
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/33a336f0 -e0ef-11e8 -b690 -
01aa75ed71a1/l anguage -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 The inst rument is a Delegated Direc tive, 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 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 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 IV  to 
Directive  2011/65/EU of the European Parliament and of the Council as regards an 
exemption for lead in platinized platinum electrodes used for certain conductivity 
measurements  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Tre aty 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 the hazardous substances  listed in 
Annex II to that Directive.  That restriction  does not apply to certain  exempted  
applications which are specific to medical devices and monitoring and control 
instruments  and are listed in Annex IV to that Directive . 
(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 2014/73/EU2, the Commission granted an exemption for  the 
use of lead in platinized platinum elect rodes used for conductivity measurements 
where certain conditions apply (“the exemption”), by including the relevant 
applications  in Annex IV to Directive 2011/65/EU. The exemption was to expire on 31 
December 2018, in accordance with the third subparagrap h of Article 5(2) of that 
Directive.  
(5) The Commission received an application for renewal of the exemption (“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 provi sion, the 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.  
                                                 
1 OJ L 174, 1.7. 2011, p. 88.  
2 Commission Delegated Directive 2014/73/EU of 13 March 2014 amending, for the purposes of 
adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of 
the Council as regards an exemption for lead in plati nized platinum electrodes used for conductivity 
measurements (OJ L 148, 20.5.2014, p. 80).  EN 5  EN (7) Lead -containing p latinized platinum electrodes are used in specialised instruments for 
measurements which require  certain measurement qualities such as wide range, high 
accuracy,  or high reliability for high c oncentration of acid and alkali . 
(8) Due to the lack of reliable alt ernatives, a  substitution or elimination of lead  in the 
applications concerned is currently scientifically and technically impracticable  for 
certain  measurement instruments . The renewal of the exemption  is consistent with 
Regulation (EC) No 1907/2006 of th e European Parliament and of the Council3 and 
thus does not weaken the environmental and health protection afforded by  it.  
(9) It is, therefore, appropriate to grant the renewal of t he exemption . 
(10) The exemption should be renewed for the maximum duration of 7 years until 31 
December 2025 , in accordance with Article 4(3) and the third  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 h ave adverse impacts 
on innovation .  
(11) Directive 2011/65/EU should therefore be amended accordingly,   
 
HAS ADOPTED THIS DIRECTIVE:  
Article 1  
Annex IV 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.  
                                                 
3 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning the Registration, Evaluation, Authorisation and Restricti on 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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