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 the use of cadmium in certain radiation tolerant video camera tubes  
(Tex t 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 
cadmium . 
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 subst ances 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 provides  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 wea ken 
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 m aterials 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 t he 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 Commission received a request  for a new  exemption for use of c admium in video 
cameras designed for use in environments exposed to ionising radiation with a dose rate in 
excess of 100  Gy/hour and a total dose in excess of 100  kGy with a centre resolution greater 
than 450 TV Lines  in December 2015 (request no. A -2016).  
With a view to evaluat ing the application  for exemption , the Commission launched a study to 
carry out the required technical and scientific assessment,  including an eight -week online 
                                                 
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 open -ended stakeholder consultation4 on the applica tion. One contribution w as made to the 
stakeholder consultation.  
The final report containing the assessment of the application was published5; stakeholders 
were notified.  
Subsequently, the Commission consulted the Member States expert group for delegated acts 
under RoHS 2  during an expert meeting on 22 September 2017 . The experts agreed with the 
draft presented, with a large group  of experts remain ing silent . All necessary steps relating to 
exemptions from the substance restriction pursuant to Article s 5(3) to 5(7) have been 
performed .6 The Council and the European Parliament were notified of all activities.  
The final report  highlighted in particular the following technical information and assessment : 
 Radiation tolerant video cameras are used for inspection and general surveillance 
activities in nuclear power plants  as well as in nuclear fuel waste  processing plants . 
To withstand high radiation levels specific to these facilities  while reaching a 
sufficient level of optical performance, specia lised camera tubes with a layer containing 
58.7% of cadmium  by weight are necessary . 
 Currently, there are no cadmium -free alternatives available on the market which 
would provide the necessary combination of optical performance and sufficient radiation 
resistance .  
The applications concerned by the exemption request fall in category 97; the exemption 
request therefore relates to Annex IV of Directive 2011/65/EU. The evaluation results 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, granting the exemption with the 
maximum validity period of seven years 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 cadmium  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.  
                                                 
4 Consultation period : from 28 O ctober until  22 December 2016.  
5 https://publications.europa.eu/en/publication -detail/ -/publication/e8c8a008 -3e99 -11e7 -a08e -
01aa75ed71a1   
6 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 Interi nstitutional Registry of Delegated Acts 
at https://webgate.ec.europa.eu/regdel/#/home . 
7 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 equipment; 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 EEE not covered by any of the categories above.  EN 3  EN 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 equip ment , 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 technica l 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 the use of cadmium in c ertain radiation tolerant video camera tubes  
(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 restriction of the use of certain hazardous substances in electrical and 
electronic equipment8, 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 specif ic to medical devices and monitoring and control 
instruments and are listed i n 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) Cadmium  is a restricted substance listed in Annex II to Directive 2011/65/EU.  
(4) On 3 December 2015, the Commission received an application made i n accordance 
with Article 5( 3) of Directive 2011/65/EU for an exemption  to be listed in Annex IV  
to that Directive , for the use of cadmium in certain radiation tolerant video camera 
tubes  ("the requested exemption") .  
(5) The evaluation of the request included stakeholder consultations in accordance with 
Article 5(7) of Directive 2011/65/EU.  
(6) Cadmium  in video camera tubes  is necessary to achieve satisfactory radiation 
tolerance and optical performance of video cameras operating in environments with  
high radiation exposure, such as nuclear power plants and nuclear waste reprocessing 
facilities . 
(7) Currently, there are no cadmium -free alternatives available on the market which would 
provide the necessary combination of optical performance and sufficient radiation 
resistance .  
(8) Due to the lack of alternatives, a  substitution or elimination of cadmium  is 
scientifically and technically impracticable  for certain video camera tubes . The 
exemption is consistent with Regulation (EC) No 1907/2006 of the European 
                                                 
8 OJ L 174, 1.7.2011 , p. 88.  EN 5  EN Parliament and of the Council9 and thus  does not weaken the environmental and health 
protection afforded by  it.  
(9) It is, therefore, appropriate to grant t he requested exemption by including the 
applications covered by it in Annex IV to Directive 2011/65/EU with respect to 
electrical and electronic equipment of category 9.  
(10) The requested exemption should be granted for a duration of 7 years starting from  [the 
date of the publication of this Directive in the Official Journal ], in accordance with the 
first 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 have 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 th is Directive.  
Article 2 
1. Member States shall adopt and publish, by [the last day of the 5th 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 5th 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 Comm ission 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 U nion. 
Article 4 
This Directive is addressed to the Member States.  
                                                 
9 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).  EN 6  EN Done at Brussels,  
 For the Commission  
 The President  
 […]