EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2015) 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 
cadmium anodes in Hersch cells for certain oxyge n sensors used in industrial monitoring
and control instruments 
(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 for applications containing cadmium. 
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 in electrical and electronic 
equipment. RoHS 2 (recast) entered into force on 21 July 2011. 
The restricted substances are list ed in Annex II of RoHS 2; wh ile to date the restriction of 
lead, mercury, cadmium, hexavalent chro mium, polybrominated biphenyls, and 
polybrominated diphenyl ethers restriction is being enforced, the restriction of 
bis(2-ethylhexyl) phthalate (DEH P), butyl benzyl phthalate (BBP ), dibutyl phthalate (DBP), 
diisobutyl phthalate (DIBP) shall be enfor ced from 22 July 2019. Annexes III and IV of 
RoHS 2 list the materials and components of Electrical and Electroni c Equipment (EEE) for 
specific applications exempted from the substa nce restriction in Arti cle 4(1) of RoHS 2. 
Article 5 contains the provisions for the adap tation to scientific and technical progress 
(inclusion and deletion of exemptions) of Anne xes III and IV. Pursuant 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 prot ection 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 an d 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 negativ e environmental, health  and consumer safety 
impacts caused by substitution are likely to outw eigh the total environmental, health and 
consumer safety benefits thereof. 
Article 5 establishes the procedure for the adaptation of the Annexes to scientific and 
technical progress. Article 5(1) provides th at the European Comm ission (the Commission) 
shall include materials and components of EEE for specific applicati ons in the lists in 
Annexes III and IV by means of individual de legated acts in accord ance with Article 20. 
 
2. CONSULTATIONS
 PRIOR  TO THE  ADOPTION  OF THE  ACT 
As a consequence of the provisions in Article  5(3) and Annex V for granting, renewing or 
revoking an exemption, which allo ws stakeholders to apply for an exemption from the 
substance restriction, the Commission has re ceived about 50 requests for new exemptions 
since the publication of RoHS  2 and about 100 requests to renew existing exemptions. 
The Commission received an application on th e 28 April 2014 in relation to the use of 
cadmium in equipment requiring high-sensitivit y in oxygen measurement. In Annex IV to 
RoHS 2, the exemption 1b "Lead anodes in elec trochemical oxygen sensors" allows for the 
use of lead (Pb) in anodes of oxygen sensor s; however, these lead anodes are unable to 
provide the levels of sensitivity (measurements of tens or hundreds of parts per trillion) and 
stability required by certain industries. 
                                                 
1 OJ L 174, 1.7.2011, p. 88.  
EN 3   EN With a view to evaluate the application fo r exemption, the Commission commissioned a study 
and carried out the requisite technical and scientific assessment including an official 8-week online open-ended stakeholder consultation
2 for the application3. No contributions were 
received during the stakeholder consu ltation for the application concerned. 
The final report for the application assessment was written by consultants Oeko Institute, 
approved by DG Environment and published4; stakeholders and Member  States were notified. 
The project page is accessibl e via the DG Environment webpage5. 
Subsequently, the Commission consulted the o fficial expert group fo r delegated acts under 
RoHS 2. A proposed modification of the RoHS 2 Annex IV with all necessary background 
information was sent out on 9 September 2015 a nd experts were invited to comment on the 
proposal by 8 October 2015. The expert group unanimously supported the proposal to exempt 
cadmium anodes in Hersch cells for oxygen sensor s used in industrial monitoring and control 
instruments, where sensitivity below 10 parts per million is required, for a duration of seven 
years. All necessary steps pursu ant to Article 5(3) to (7) ha ve been performed. Council and 
Parliament were notified of all activities. 
According to the final report, the following technical information was collected (for further 
information see footnote 4): 
• Cadmium (Cd) is present in the anodes of Hersch Cells, which are used in 
specialized, high sensitivity oxygen sensors.  While alternative oxygen sensors exist, 
it has been proven that all these available alternative technologi es do not provide the 
same sensitivity, reliability and accuracy related to the Hersch cell sensors when measuring oxygen concentration at very low levels. 
• Though some of the other technologies could be  applied at such very low levels in 
theory, their need for calibration at such le vels would make thei r use in practice not 
sufficiently reliable. Indeed, though alternatives could be used for high sensitivity 
measurements, the calibration limitations  would not provide for a sensor with 
comparable sensitivity and reliability sp ecifically when measuring levels below 10 
part per million of oxygen. 
• The reliability of alternativ es to Hersch Cells using cadmium for oxygen sensors in 
industrial monitoring and c ontrol instruments is therefore not ensured where 
sensitivity below 10 parts per million is required. Below this level, an exemption would thus be in line with Art. 5(1)(a), as at least one of the three main criteria would 
be fulfilled. 
• The duration of a new sensor devel opment project, including the redesign, 
recertification and la unch onto the market in the form of an oxygen sensor, is 
typically close to 7 years for industrial monitoring and control instruments. A suitable substitute is unlikely to appear ont o the market within the next 7 years. 
                                                
 
2 http://ec.europa.eu/environment/consultations/rohs12_en.htm ; consultation period from 31.10.2014 to 
09.01.2015  
3 The list of consulted stakeholders is regularly upda ted and maintained by the consultants in cooperation 
with the Commission, and includes electronics related industry organisations, manufacturers and 
suppliers, recyclers, consumer associations, NGOs , academia, Member States' representatives, etc. 
4 Direct link to evaluation and recommendation:  https://circabc.europa.eu/sd/a/dc3ec089-8ce1-4592-
93d7-12e7fbbefc44/20150624_RoHS_Ex_Pack6_Final_Report.pdf , 
http://rohs.exemptions.oeko.info/fileadmin/user_upload/reports/20150624_RoHS_Ex_Pack6_Final_Rep
ort.pdf . 
5 http://ec.europa.eu/envi ronment/waste/rohs_eee/ studies_rohs1_en.htm .  
EN 4   EN With respect to the insertion of th e following exemption in Annex IV " Cadmium anodes in 
Hersch cells for oxygen sensors used in industr ial monitoring and control instruments, where 
a sensitivity below 10 ppm is required ", the evaluation results show  that at least one of the 
relevant criteria specified in Article 5(1)(a) is fulfilled and the inclusion of the specific 
application in the exemptions listed in Annex IV is thus justified, as currently no cadmium-free alternatives are sufficiently reliabl e for the specific use. No current exemption 
exists in Annex IV to which this new exempti on could be associated for similarity in the 
technical assessment and validity period. Thus, considering that for monitoring and control 
instruments 7 years is a relatively short tran sition period which is unlikely to have adverse 
impacts on innovation, pursuant to Article 5(2)  of Directive 2011/65/EU, the validity period 
of the exemption should be 7 years. This pe riod is unlikely to have adverse impacts on 
innovation as no alternative are available today or are likely to come to market in the same 
period. 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. 
 
3. LEGAL
 ELEMENTS  OF THE  DELEGATED  ACT 
The proposed act grants an exemption from the substance restrictions of Directive 
2011/65/EU (RoHS 2), to be listed in Annex IV, for the use of cadmium in specific 
applications. 
The proposed instrument is a delegated dir ective, which implements Directive 2011/65/EU, 
and in particular Arti cle 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 
substances in line with the provisions 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 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 
cadmium anodes in Hersch cells for certain ox ygen sensors used in industrial monitoring 
and control instruments 
(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 equipment
6, and in particular Article 5(1)(a) thereof, 
Whereas: (1) Directive 2011/65/EU prohibits  the use of cadmium in el ectrical and electronic 
equipment placed on the market. Cadmium is present in the anode s of Hersch Cells, 
which are used in specialized, high-sensitiv ity oxygen sensors. In comparison to the 
Hersch cell sensors, all av ailable alternative technologi es do not provide the same 
sensitivity, reliability and accuracy when measuring oxygen concentration at very low 
levels. 
(2) The reliability of alternatives to Hersch Cells using cadmium for oxygen sensors in 
industrial monitoring and control instrument s is not ensured where sensitivity below 
10 parts per million is required. The use of  cadmium anodes in Hersch cells for 
oxygen sensors used in industrial monito ring and control instruments, where 
sensitivity below 10 parts per million is re quired, should therefore be exempted from 
the prohibition. 
(3) As currently no cadmium-free alternatives are sufficiently reliable for the specific use 
and considering that for monitoring and cont rol instruments seven years is a relatively 
short transition period which is unlikely to have adverse impacts on innovation, 
pursuant to Article 5(2) of  Directive 2011/65/EU, a corres ponding validity period of 
exemption should be granted. 
(4) 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. 
                                                
 
6 OJ L 174, 1.7.2011, p. 88.   
EN 6   EN Article 2 
1. Member States shall bring into force the laws, regulations and administrative 
provisions necessary to comply with this Directive by [ OP, please insert, as concrete 
date, the last day of the 9th month after entry into force of this directive ] at the latest. 
They shall forthwith communicate to the Co mmission 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  […]