EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2022) XXX  draft  
 
COMMISSION DELEGATED DIRECTIVE (EU) .../…  
of XXX  
amending Directive 2011/65/EU of the European Parliament and of the Council as 
regards an exemption for lead as a thermal stabilizer in polyvinyl chloride used as base 
material in sensors used in in -vitro diagnostic medical devices  
(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 and 
scientific progress, Annex IV to 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 ( ‘the RoHS Directi ve’)1 as regards an exemption for lead in polyvinyl 
chloride (PVC) used as base material in sensors used in in -vitro diagnostic medical devices . 
Article  4 of the RoHS Directive restricts the use of certain hazardous substances in electrical 
and electroni c equipment. Currently, 10  substances  (or groups of substances)  are restricted 
and listed in Annex II to the Directive: lead, mercury, cadmium, hexavalent chromium, 
polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), bis(2ethylhexyl) 
phtha late (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl 
phthalate (DIBP).  
Annexes III and IV to the Directive  list the materials and components of electrical and 
electronic equipment  for specific applications exempted from the sub stance restrictions in 
Article  4(1). Article  5 provides for Annexes III and IV to be adapted to scientific and 
technical progress ( on granting, renewing and revoking of exemptions). Under Article  5(1)(a), 
exemptions are to be included in Annexes III and IV  only if this does not weaken the 
environmental and health protection afforded by Regulation (EC) No  1907/2006 (REACH)2 
and if any of the following conditions is fulfilled:  
– the elimination or substitution of the substance via design changes or use of mater ials 
and components that 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;  
– the total negative environmental, health and consumer safety impact s of substitution 
are likely to outweigh the total environmental, health and consumer safety benefits.  
Decisions on exemptions, and their duration, must  take into account the availability of 
substitutes and the socio -economic impact of substitution. Decisi ons on the duration of 
exemptions must take into account any potential impact on innovation. Life -cycle thinking on 
the overall impacts of the exemption must apply, where relevant.  
Article  5(1) provides for the Commission to include materials and component s of electrical 
and electronic equipment  for specific applications in the lists in Annexes  III and IV by means 
of individual delegated acts pursuant to Article  20. Article  5(3) and Annex  V establish the 
procedure for submitting exemption applications.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The Commission receives numerous requests from economic operators to grant or renew 
exemptions under Article  5(3) and Annex V to the RoHS Directive3. 
                                                 
1 OJ L 174, 1.7.2011, p.  88. 
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). 
3 The list is available at: http://ec.europa.eu/environment/waste/rohs_eee/adaptation_en.htm . EN 2  EN On 1 December  2021, the Commission received an application for a new entry to be added to 
Annex  IV. The requested exemption concerns lead as a thermal stabilizer 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 creatinine and blood urea nitrogen (BUN) in whole blood . 
In March  2022, the Commission launched an  evaluation to  carry out the required technical 
and scientific assessment. The study, which include d a six-week public stakeholder 
consultation, was published  in September  20224. Information about the consultation was 
provided on the project website5 and no stakeholder contribution was received . 
On 26 October  2022 , the Commission consulted the Member State s expert group for 
delegated acts under the RoHS  Directive ; one comment was  received . It carried out all the 
required procedural steps relating to exemptions from the restrictions on substances under  
Articles 5(3) to 5(7)6. In this context , the European Parliament and the Council were notified 
of all activities.  
Technical evaluation  
Lead is a toxic substance which affects the development of the nervous system, produces 
chronic kidney disease and has adverse effects on blood pressure.  
Lead is  used as thermal stabiliser in PVC  as base material  for sensor cards. Those cards are  
part of disposable cartridges used in diagnostic medical analyser  that can provide accurate 
measurement of specific analytes (e.g., sodium, chloride, glucose, pH value et c.) on a single 
whole blood sample. Those medical analysers are used  to obtain blood results in a short time  
near the point of care ( e.g., in emergency departments ). The previous exemption 41 in Annex 
IV of the RoHS Directive covered such applications.  
The substitution of lead in such applications is progressing and other manufacturers of similar 
devices have already substituted lead in their sensors. However, f or sensor cards analysing the 
parameter creatinine and blood urea nitrogen (BUN), the development is not sufficiently 
progressed to replace such sensor cards. Lead-free sensor cards are in development by the 
applicant but are not yet market ready as their lead substitution is not reliable enough or their 
accuracy is too low.  
It is expec ted that the development and validation of substitutes for lead in sensor cards 
relevant for the two parameters creatinine and BUN can be finalised by the end of 2023.  
Rejecting the exemption request can be expected to have a considerable impact on health 
service providers using equipment already on the market, as such devices can become non -
functional as long as lead containing PVC sensor cards cannot be replaced.  
It is expected that  under a potential exemption for  this period  until end of 2023  less than 14.2 
kg of lead is placed on the market.  
                                                 
4 Study to assess request for one ( -1-) exemption, for lead as a thermal stabilizer in polyvinyl chloride 
(PVC) used as base material in amperometric, poten tiometric and conductometric electrochemical 
sensors which are used in in -vitro diagnostic medical devices for the analysis of creatinine and blood 
urea nitrogen (BUN) in whole blood, in Annex IV of Directive 2011/65/EU (Pack 26)  
https://op.europa.eu/en/publication -detail/ -/publication/49205318 -3249 -11ed -975d -
01aa75ed71a1/language -en  
5 Consultation period: 07 April 2022 to 19  May 2022 (https://rohs.exemptions.oeko.info/exemption -
consultations/2022 -consultation -1 ). 
6 A list of the required administrative steps is available on the Commission website . The 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 proposed act grant s an exemption from the substance restrictions in Annex II to Directive 
2011/65/EU, to be listed in Annex IV, for lead in polyvinyl chloride used as base material in 
sensors used in in -vitro diagnostic medical devices .  
In-vitro diagnostic medical devices  can be assigned to the EEE category 8 “medical devices ” 
according to Annex I.  
At least o ne of the relevant criteria specified in Article 5(1)(a) is met by  the exemption 
request : the reliability of substitutes for the specific application subject to the exemption 
request is not ensured. Also, the total negative environmental, health and consumer safety 
impacts  and the socioeconomic impacts of not granting an  exemption  are being taken into 
account, in light of A rticle 5(a), third indent and the second subparagraph of Article 5(a). 
Granting an exemption would  prevent  negative impacts on health facilities as specific 
parameters could be continued to be analysed with sufficient accuracy and medical devices 
already on the market could continue to be used.  
Lead and its compounds are  also restricted by REACH entry 63 of Annex XVII . This entry is 
currently under review and should  include in future a restriction of le ad for articles produced 
from polymers or copolymers of PVC.  A possible restriction for lead in PVC will come into 
force later than 2023. The requested exemption under RoHS is only necessary until lead is 
replaced in the specific sensor cards , which is for eseen for the end of 2023.  With an expiry 
date not later than end of 2023 , the exemption to be granted would not weaken the 
environmental and health protection afforded by the REACH Regulation, in accordance with 
Article  5 of Directive 2011/65/EU.  
In summary, the unavailability of a reliable substitution for the concrete application combined 
with negative environmental, health and consumer safety impacts of not granting the 
exemption, justifies granting the exemption for a limited duration when substit ution of lead is 
envisaged.  
The expiry date of the exemption would hence be set with 31 December 2023 , in line with 
Article  5(2), first subparagraph , RoHS Directive . 
It is proposed to add a new entry 41a for the relevant application in Annex I V. Since the in-
vitro diagnostic medical devices  described in the exemption request  fall under category 8 
“medical devices ” of Annex I, the scope of the exemption should be limited to th ose. 
The legal instrument is a delegated directive, as provided for in Directive 20 11/65/EU and 
meeting the relevant requirements of its Article  5(1)(a).  
The objective of the delegated directive is to  protect human health and the environment, and 
to harmonise provisions for the functioning of the single market in the field of electrical and 
electronic equipment , by allowing the use of otherwise banned substances for specific 
applications, in line with the RoHS Directive and the procedure established therein for 
adapting Annexes III and IV to the Directive to scientific and technical progr ess. 
The delegated directive has no implications for the EU budget.  EN 4  EN COMMISSION DELEGATED DIRECTIVE (EU) .../…  
of XXX  
amending Directive 2011/65/EU of the European Parliament and of the Council as 
regards an exemption for lead as a thermal stabilizer in polyvinyl chloride used as base 
material in sensors used in in -vitro diagnostic medical devices  
(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 Parliament 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), p oint (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  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 liste d in Annex II to Directive 2011/65/EU.  
(4) On 1 December 2021 , the Commission received an application made in accordance 
with Article  5(3) of Directive 2011/65/EU for an exemption to be listed in Annex I V 
to that Directive , for lead as a thermal stabilizer in polyvinyl chloride used as base 
material in sensors used in in -vitro diagnostic medical devices  (‘the requested 
exemption’).  
(5) The in-vitro diagnostic medical devices  described in the requested exemption fall 
under category 8 ‘medical devices ’ of Annex I to Directive 2011/65/EU.   
(6) A technical and scientific assessment study2 was carried out to evaluate the requested 
exemption. The evaluation included stakeholder consultations as required by Article 
5(7) of Directive 2011/65/EU.  The comments rece ived during those consultations 
were made publicly available on a dedicated website.  
(7) The evaluation of the requested exemption  concluded that the substitution of lead in 
specific sensors  is not completed yet. The availability of substitutes for such specif ic 
                                                 
1 OJ L 174, 1.7.2011, p.  88. 
2 Study to assess request for one  (-1-) exemption, for lead as a thermal stabilizer 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 creati nine and blood 
urea nitrogen (BUN) in whole blood, in Annex IV of Directive 2011/65/EU (Pack 26)  
 EN 5  EN devices is not ensured as c urrent lead substitutions are not reliable for all parameters 
(for example , creatinine  and blood urea nitrogen) or have a low accuracy for such 
parameters. In addition, the evaluation concluded that rejecting the requested 
exemption would negatively affect the health service.   
(8) The requested exemption thus meets a t least o ne of the relevant conditions  specified in 
Article  5(1), point (a), of Directive 2011/65/EU as the reliability of substitutes for the 
specific application subject to the exemption request is not ensured . Also, the overall  
negative environmental, health and consumer safety impacts and the socioeconomic 
impacts of not granting an exemption are being taken into account . 
(9) The requested exemption is consistent wit h Regulation (EC)  No 1907/2006 of the 
European Parliament and of the Council3 and thus does not weaken the environmental 
and health protection afforded by  that Regulation . 
(10) It is, therefore, appropriate to grant the requested exemption by including the relevant 
application in Annex I V to Directive 2011/65/EU  with respect to electrical and 
electronic equipment of category 8. 
(11) In light of the expected availability of substitution of lead in the application subject to 
the exemption and of possible future restriction s on lead in polyvinyl chloride in 
Regulation (EC) No 1907/2006 , it is necessary to  grant the exemption for a  limited 
validity  period until 31 December 202 3. That validity  period is set in accordance with 
Article 5(2), first subparagraph , of Directive 2011/65/EU.  
(12) 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 pu blish, by [ OP please insert the date: the last day of 
the sixth 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 com municate the text of  those provisions to the 
Commission.  
They shall apply those provisions from [ OP please insert the date: the last day of the 
sixth month after the date of entry into force of this Directive + 1 day ]. 
When Member States adopt those provis ions, 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.  
                                                 
3 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning the Registration, Evaluation, Authorisation and Re striction of Chemicals (REACH), 
establishing a European Chemicals Agency , amending Directive 1999/45/EC and repealing Council 
Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council 
Directive 76/769/E  EC and Commission Direc tives 91/155/EEC, 93/67 /EEC, 93/105/EC and 
2000/21/EC (OJ L 396, 30.12.2006, p. 1).  EN 6  EN 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 at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN