EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2014) XXX  draft 
  
COMMISSION DELEGATED DIRECTIVE ../…/EU 
of XXX  
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 
(Text with EEA relevance) 
  
EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT 
Subject: Commission Delegated Directive amending, for the purposes of ad apting to technical 
progress, Annex IV of the Directive 2011/65/EU  of the European Parliament and of the 
Council as regards an exemption fo r applications containing lead. 
Directive 2011/65/EU of the European Parl iament and of the C ouncil of 8 June 2011 
(RoHS 2)1 restricts the use of certain hazardous  substances (lead, mercury, cadmium, 
hexavalent chromium, polybrominated biphe nyls, polybrominated diphenyl ethers) in 
electrical and electronic equi pment. RoHS 2 (recast) entered into force on 21 July 2011. 
The restricted substances are listed in A nnex II of RoHS 2. Annexes III and IV list 
exemptions of materials and components from the substance restrictions under Article 4(1). 
Article 5 provides for the adaptation to scie ntific and technical progress (inclusion and 
deletion of exemptions) of Annexes III and IV. Purs uant to Article 5(1)a, exemptions shall be 
included in Annexes III and IV, provided that  such inclusion does not weaken the 
environmental and health protection afforded  by Regulation (EC) No 1907/2006 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 nega tive environmental, health and consumer safety impacts caused 
by substitution are likely to ou tweigh the total environmental, health and consumer safety 
benefits thereof. 
Article 5 of RoHS 2 establishes a procedure for the adaptation of the Annexes to scientific 
and technical progress. RoHS 2 Article 5(1)  provides that the Co mmission shall include 
materials and components of EEE fo r specific applicati ons in the lists in Annexes III and IV 
by means of individual delegated acts in accordance with Article 20.  
2. CONSULTATIONS
 PRIOR  TO THE  ADOPTION  OF THE  ACT 
In line with the provisions in Article 5(3) and Annex V fo r granting, renewing or revoking an 
exemption, which allow stakeholders to apply fo r an exemption of the restricted substance , 
the Commission has received almost 50 requests for new exemptions since the publication of 
RoHS 2. With a view to evaluate the re quested exemptions, the Commission commissioned 
several studies and carried out the requisite technical and scie ntific assessment including an 
official stakeholder consultation2 for each application.3 The final report, written by 
consultants Oeko Institute and ap proved by DG Environment, for this application is available 
on the consultants' webpage4; stakeholders and Member Stat es were notified. The project 
page is accessible via the DG Environment webpage5. 
                                                 
1  OJ L 174, 1.7.2011, p. 88. 
2  http://ec.europa.eu/environment/consultations/rohs7_en.htm ; consultation period 19 August to 11 
November 2013. 
3 The consultation list is regularly updated and maintained by the consultants in cooperation with the 
Commission, and includes electronics related industry organisations, manufacturers and suppliers, 
recyclers, consumer associations, NGOs, acad emia, Member States' representatives, etc. 
4 Direct link to evaluation and recommendation: 
http://rohs.exemptions.oeko.info/fileadmin/user_upl oad/RoHS_IX/20140422_RoHS2_Evaluation_Ex_Requests_
2013-1-5_final.pdf , pages 27-39. 
5  http://ec.europa.eu/environment/w aste/rohs_eee/studies_rohs1_en.htm.  
EN 3   EN Subsequently, the Commission consulted the o fficial expert group fo r delegated acts under 
RoHS 2. A meeting with consultants and e xperts was held on 25 June 2014, a consolidated 
recommendation with all necessary background in formation was sent out on 1 July 2014 and 
experts were invited to comment on the proposal by 25 August 2014. The expert group 
unanimously supported the proposal to exempt lead  in polyvinyl chloride sensors in in-vitro 
diagnostic medical devices unti l 31 December 2018. All necessary  steps pursuant to Article 
5(3) to (7) have been performed. Council and Parliament were notified of all activities. 
According to the final report, the following t echnical information as  discussed in public 
consultation was collected (for further information see footnote 4): 
Blood, body fluid and body gas analys ers serve as a critical anal ytical instrument across the 
EU and global health care sect or. Blood testing is a core element to virtually all diagnostic 
and therapeutic procedures carried out in the h ealth care sector today. Lead is used as a 
stabiliser for processing  PVC which is used as base mate rial in the sensor cards of the 
cartridges used in these critical care analysers.  The PVC sensor card is the primary unit of the 
cartridge and represents a complicated and compact technological unit with an 
electrochemical process ta king place during the testing. 
Unlike alternatives such as tin, the lead in the sensor card does not interfere with the 
measurement of electrolytes. Al though research of substitutes for lead to be used as a 
stabiliser in PVC sensor cards  is ongoing, a suitable alternativ e is not yet av ailable. Known 
metal based PVC stabilisers aff ect the performance while the re search of non-metallic organic 
stabilisers will require more time. The perfor mance of tested metal alternatives does not 
match technical requirements as it interferes  with results. On the basis of the available 
information, substitution is technically impractic able for this specific ap plication at present. 
The elimination of lead via the substitution of PVC in the sensor  card is not ye t possible, due 
to the heavy-duty product requirements for in-v itro diagnostics and the additional cost of 
substitution. 
Both the substitution of lead in PVC sensor cards for in-vitro medical devices and the 
elimination of lead via substitution of PVC in th ese applications are technically impracticable. 
In light of the first Article 5( 1)(a) criterion, an exemption is justified, and should be granted 
until the end of 2018. In view of the relatively long innovation cycles for medical devices in 
comparison to consumer products this is a rath er short transition period which is unlikely to 
have adverse impacts on innovation as no substit utes are available toda y or before December 
2018. 
The specific exemption does not weaken the envi ronmental and health protection afforded by 
Regulation (EC) No 1907/2006 (REACH) in acco rdance with Article 5 of Directive 
2011/65/EU. 
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT 
The proposed act grants an exemption from the s ubstance restrictions in  Annex II of Directive 
2011/65/EU (RoHS 2), to be listed in Annex IV, fo r the use of lead in specific applications. 
The proposed instrument is  a delegated directive. 
The draft delegated directive implements Di rective 2011/65/EU, and in  particular Article 
5(1)(a) thereof. 
The objective of the proposed act is to ensu re legal certainty and sustainable market 
conditions for electronic  manufacturers, by allowing specific applications of otherwise banned  
EN 4   EN substances in line with the provisions of RoHS 2 and the therein established procedure for the 
adaptation of the Annexes to scie ntific and tec hnical progress. 
In accordance with the principle of proportiona lity, 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 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 
(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 Eu ropean Parliament and of the Council of 8 
June 2011 on the restriction of the use of cert ain hazardous substances in electrical and 
electronic equipment
6, and in particular Article 5(1)(a) thereof, 
Whereas: (1) Directive 2011/65/EU prohibits the use of lead in electrical and electronic equipment 
placed on the market.  
(2) Blood, body fluid and body gas analysers serve as  a critical analyti cal instrument in 
many diagnostic and therapeutic procedures. Lead is required as a stabiliser in the 
processing of the PVC for the sensor cards. Although research of substitutes is ongoing, a suitable alternative is not yet available. The performance of tested 
alternatives both to lead in PVC and to PV C itself does not meet the specific technical 
requirements.  
(3) Both the substitution of lead in PVC sensor  cards for in-vitro diagnostic medical 
devices for blood, body fluid and body gas analys is and the elimina tion of lead via 
substitution of PVC in these applicat ions are technically impracticable. 
(4) The use of lead in PVC sensors for blood, body fluid and body gas analysis used in in-
vitro diagnostic medical devices should therefore be exempted until 31 December 
2018. In view of the innovation cycles for me dical devices this is a short transition 
period which is unlikely to have adverse impacts on innovation. 
(5) 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 bring into force the laws, regulations and administrative 
provisions necessary to comply with this Di rective by the last day of the ninth month 
                                                
 
6 OJ L 174, 1.7.2011, p. 88.   
EN 6   EN after entry into force at the latest. They shall forthwith communicate to the 
Commission the text of those provisions. 
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 determin e 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 tw entieth 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  […]