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 as a thermal stabiliser in polyvinyl chloride used in certain in -vitro 
diagnostic medical devices for the analysis of blood and other body fluids and body gases  
(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 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 substances 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 (DBP) 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 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 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 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.  
Decisions on exemptions, and their duration, are furthermore to take into account the 
availability of substitutes and the socioeconomic impact of substitution; and  decisions on the 
duration of exemptions shall take into account any potential impact on innovation. Life -cycle 
thinking on the overall impacts of the exemption shall apply, where relevant.  
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 41 permits the use of lead as a thermal stabiliser in 
polyvinyl chloride (PVC) used as base material in amperometric, potentiometric and  
conductometric electrochemical sensors which are used in in -vitro diagnostic medical devices 
                                                 
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 for the analysis of blood and other body fluids and body gases . The Commission received one 
application  for renewal of this exemption in June 2017 . While exemptio n 41 had 31 
December  2018 as expiration date for categor y 8 in vitro diagnostic medical devices , in line 
with the requirements of the RoHS Directive (Article 5(5), second subparagraph), it continues 
to apply until a decision on the renewal application is t aken 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 applicatio n. One contribution was 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 activities.  
The final report  highlighted in particular the following technical information and assessment : 
 Lead in the PVC sensor card  of concerned in vitro medical devices  (blood analysers)  
is enhancing sensor performance which is necessary  for the optimum performance in 
terms of analytical reliability claimed in product publications  and thus for fulfil ment 
of requirements set by EU legislation on in  vitro diagnostic medical devices.  
 While lead -free technologies are available on the market for certain analysers  of 
other manufacturers, the applicant requires additional time to test the reliability of 
substitutes and to achieve compliance . Should the lead-based applications  be 
discontinued  without providing additional time to the applicant , a premature 
generation of 112,000 kg of waste EEE  can be  expected. Furthermore,  as the devices 
concerned cover  30 % of blood analysers  market  in the EU , significant c osts for 
health providers are presumed . 
 At least one of the relevant criteria specified in Article 5(1)(a) is met by the 
application subject to the exemption request: the total negative environmental, health 
and consumer safety impacts by substitution (i.e . premature generation of waste 
EEE) are likely to outweigh the total environmental, health and consumer safety 
benefits thereof (avoidance of approx. 157 kg of lead to be placed on the market).  
The evaluation results for categor ies 8 in vitro medical devi ces show that the specific 
exemption would at this point 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.  Under Regulation (EC) No 1907/2006 (REACH), there is a restriction process 
                                                 
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 on lead in PVC ongoing since 2016. The recent publication of a draft restriction proposal 
under REACH8 provides sufficient indications with regard to lead in  PVC in order to proceed  
with the decision under RoHS. In any case, in light of the ongoing REACH restriction 
process, the renewal of the exemption should be granted for a short validity period of 2 years 
starting from the date of the publication of the Delegated Directive in the  Official Journal to 
ensure alignment with REACH once the res triction process is concluded. The validity period 
for the exemption being very short, it is also not expected to have adverse impacts on 
innovation.  The exemption renewal granting additional tim e for achieving compliance will 
further avoid negative socioeconomic impacts of substitution for certain health providers that 
would otherwise arise . The granted validity period is also not expected to have adverse 
impacts on innovation .  
 
3. LEGAL  ELEMENT S 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.  
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 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.  
 
                                                 
8  Draft Commission Regulation amending Annex XVII to Regulation (EC) No 1907/2006 of the 
European Parliament and of the Council on the Registrati on, Evaluation, Authorisation and Restriction 
of Chemicals (REACH) as regards lead and its compounds is available here: 
http://ec.europa.eu/growth/tools -
databases/tbt/en/search/?tbtaction=search.detail&Country_ID=EU&num=668&dspLang=en&basdatede
b=10/07/2019 &basdatefin=18/07/2019&baspays=&basnotifnum=&basnotifnum2=&bastypepays=ANY
&baskeywords=.   
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 as a thermal stabiliser in polyvinyl chloride used in certain in -vitro 
diagnostic medical devices for the analysis of blood and other body fluids and body gases  
(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 re striction of the use of certain hazardous substances in electrical and 
electronic equipment1, and in particular Article 5(1)(a) thereof,  
Whereas:  
(1) Article 4(1) of 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 specif ic 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 (EU) 2015/5732, the Commission granted an exemption for 
the use of lead as a thermal stabiliser in polyvinyl chloride (PVC) used as base 
material in amperometric, potentiometric and conductometric electrochemical sensors 
which are used in in -vitro diagnostic medical devices for the analysis of blood and 
other body fluids and body  gases (“the exemption”), by including that application in 
Annex IV to Directive 2011/65/EU. The exemption was to expire on 31 December 
2018, in accordance with the third subparagraph of Article 5(2) of that Directive . 
(5) The Commission received an applic ation for renewal of th e exemption (“the renewal 
request”) on 25 May 2017 , that is within the time  limit laid down in Article 5(5) of 
Directive 2011/65/EU. In accordance with that provision, the exemption remains valid 
until a decision on the renewal reque st 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 (EU) 2015/573 of 30 January 2015 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 polyvinyl chloride sensors in in -vitro diagnostic 
medical devices (OJ L 94, 10.4.2015, p. 4).   
EN 5  EN (7) Lead in the PVC sensor card  of concerned in vitro medical devices (blood analysers)  
enhanc es sensor performance which is necessary  for the optimum performance of the 
device in terms of analytical reliability claimed in product publications  and thus for 
fulfilment of requirements laid down in Directive 98/79/EC of the European 
Parliament and of the Cou ncil3. 
(8) While lead -free technologies are available on the market for certain analysers  of other 
manufacturers,  reliability  testing of substitutes for the specific application subject to 
the current renewal request requires additional time .  
(9) Discontinuation of the exemption  is expected to avoid a total of 157 kg of lead being 
placed on the Union market. At the same time, however, it will result in the need to 
replace the entire diagnostic device, and consequen tly, is expected to lead to 
a prem ature generation of 112 000 kg of  waste electrical and electronic equipment. 
Furthermore, significant socioeconomic impacts on health providers using the devices 
concerned would be incurred.  
(10) The exemption does not weaken the environmental and health p rotection afforded by  
Regulation (EC) No 1907/2006 of the European Parliament and of the Council .4 In 
light of the restriction process on lead in PVC provided for in Regulation (EC) No 
1907/2006 , the exemption should be granted for a short validity period of 2 years to 
ensure full alignment with that Regulation once the relevant restriction process is 
concluded.  
(11) It is, therefore, appropriate to grant the renewal of the exemption . 
(12) The exemption concerns category 8 of electrical and electronic equipment to which 
Directive 2011/65/EU applies  and it should be renewed for the duration of 2 years 
starting from [the date of the publication of the Delegated Directive in the Official 
Journal] , in accordance with the third  subp aragraph 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 .  
(13) 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 s hall apply those provisions from  [the last day of the  12th month after the date 
of entry into force of this Directive + 1 day] . 
                                                 
3 OJ L 331, 7.12.1998, p. 1 –37. 
4 Regulation (EC) No 190 7/2006 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 When Member States adopt those provisions, they shall contain a reference to this 
Directive or be accompanied by such a referenc e 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 t his 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 at Brussels,  
 For the Comm ission  
 The President  
 […]