EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2023) 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 cadmium and lead in plastic profiles in electrical and 
electronic windows and doors containing recovered rigid polyvinyl chloride  
(Text with EEA relevan ce) 
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 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 Directive ’)1 as regards an exe mption  for specific 
applications containing cadmium  and lead . 
Article  4 of the RoHS Directive restricts the use of certain hazardous substances in electrical 
and electronic 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) 
phthalate (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 substance restrictions in 
Article  4(1). Article  5 provides for A nnexes 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 pr otection afforded by Regulation (EC) No  1907/2006 ( ‘REACH  
Regulation ’)2 and if any of the following conditions is fulfilled:  
– the elimination or substitution of the substance via design changes or use of materials 
and components that do not require any of t he 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 impacts 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. Decisions on the duration of 
exemptions must take i nto 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 components 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 The Commission received a request  for a new  exemption for use of cadmium and lead in 
plastic profiles in electrical and electronic windows and doors containing recovered polyvinyl 
chloride  (PVC)  on 14 December 2015 (request no. B-2016).  The exemption concerns 
electrical and electronic equipment listed in category 11  of Annex I4.  
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 public  
stakeholder consultation5 on the application. Eighteen contribution s were made to the 
stakeholder consultation.  The final report containing the assessment of the application was 
published6 and stakeholders were notified.  
Subsequently, the Commission consulted the Member States expert group for delegated acts 
under RoHS  during the expert meeting s on 22 September 2017  and on 21 October 20197. One 
expert explicitly supported the granting of the exemption, two Member State ex perts 
expressed their opposition , stressing mainly the need for alignment with the REACH  as well 
as to apply the same requirements to virgin and recycled material . In addition, one of the 
comments asked for removal of the symbol with “PVC”  from the  wording. This comment was 
accepted and the draft Delegated Directive  subsequently amended  accordingly . The remainder 
of experts remained sile nt. In accordance with the Better Regulation Guidelines, the draft 
Delegated Directive  was published on the Better Regulation Portal for a four -week public 
feedback period. Two comments were received , both supporting the draft proposal while 
requesting an exemption validity period of fifteen years. Furthermore, one of the comments 
questioned the applicability of the RoHS Directive to electrical and electronic windows and 
doors. All necessary steps relating to exemptions from the substance restriction pursua nt to 
Article s 5(3) to 5(7) have been performed .8 The Council and the European Parliament were 
notified of all activities.  
The final report  of the technical and scientific assessment highlighted in particular the 
following technical information and assessment : 
 Cadmium and lead are used in PVC  frame material for windows and door sets  for the 
purpose of polymer stabilisation of the PVC profiles .  
 Most of the applications for window and door  sets are not electrical. Only a small 
amount compared to all w indows and doors requires a time -limited exemption as 
they are EEE according to Article 3(1) of the RoHS Directive.  
 While lead - and cadmium -free technologies used in virgin PVC are available on the 
market , use of recovered  PVC9 requires lower  amount s of en ergy and natural 
resources (such as water, petroleum and natural salt) than would be otherwise needed 
for use of  virgin PVC . The use of recovered  PVC is thus associated with s ocio-
                                                 
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 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 mon itoring and control instruments; 10. Automatic dispensers; 11. Other EEE not 
covered by any of the categories above. Category 11 enters in scope of Directive 2011/65/EU on 22 July 2019, as 
per Article 4(3) to that Directive.  
5 Consultation period : from 28 October until  22 December 2016.  
6 Study to assess 2 RoH S new exemption requests - #1 for cadmium in video cameras designed for use in 
environments exposed to ionising radiation, #2 for lead and cadmium in PVC profiles of electric windows and 
doors : final report    
7  E02810 - Expert Group for RoHS 2 adaptation and enforcement - https://ec.europa.eu/transparency/expert -groups -
register/screen/home?lang=en   
8 A list of the required administrative steps is available on the Commissi on 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 . 
9 ‘Rec overed PVC’ refer to mixtures produced from PVC waste.   
EN 3  EN economic benefit s in particular with regard to dec arbonisation, circular economy and 
raw material availability .  
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 
impac ts by substitution (i.e. use of virgin PVC not containing lead and cadmium  associated 
with high use of raw material and primary energy) are likely to outweigh the total 
environmental, health and consumer safety benefits thereof (avoidance of lead and cadmi um 
in EEE to be placed on the market).  
In accordance with Article 5(1)(a) of Directive 2011/65/EU, the specific exemption should 
not weaken the environmental and health protection afforded by the REACH Regulation .  
Cadmium is restricted by entry 23 of Anne x XVII to the REACH Regulation . By way of 
derogation, the restriction does not apply to articles containing recovered PVC if their 
concentration of cadmium does not exceed 0,1% by weight of the plastic material in articles , 
including doors and windows. No changes on this entry are planned in the near future.  
Lead is restricted by entry 63 of Annex XVII to the REACH Regulation. A revision of this 
restriction entry  on lead in PVC  started in 2016 . In order not to weaken the protection level 
afforded by the REACH  Regulation , the decision under the RoHS Directive had to be aligned 
with the REACH Regulation restriction  proposal . In 2019, the Commission proposed a draft 
Commission Regulation restricting the use of any concentration of lead and its compounds in 
PVC  articles in a concentration equal to or greater than 0,1% by weight of the PVC material. 
A resolution objecting to the draft regulation was adopted by the European Parliament plenary 
on 12 February 202010. 
The adoption of the draft delegated act under the RoHS Directive was therefore suspended  
until a new restriction proposal , taking into account the resolution of the Parliament , is 
prepared. The Commission amended some of the provisions of the draft regulation to reflect 
the arguments brought forward by the Parliament and take into account relevant new data. A 
new draft regulation was prepared and finally adopted on 3 May 202311.  
Taking into a ccount this Commission Regulation  (EU) 2023/923 , the proposed exemption  
wording  under RoHS require d adaptation in order to fulfil the first requirement under Article 
5(1)(a). By adapting the wording and including limiting requirements (e.g., reducing 
maxim um concentration of lead in recovered PVC) of the exemption, the proposed  
exemption , subject to this delegated directive , does not weaken the environmental and health 
protection afforded by the REACH Regulation.  
The exemption is requested for a maximum val idity period, which is five years according to 
Article 5(2). The Commission Regulation (EU) 2023/923 allows profiles for windows and 
doors containing recovered rigid PVC  with lead concentration lower than 1,5% by weight,  
until 28 May 2033. By 28 May 2028, the Commission shall review entry 63, point 18 , of 
Annex XVII to Regulation (EC) No 1907/2006  in light of new scientific information and, if 
appropriate, modify it accordingly . In line with the REACH decision and in view of lacking 
technologies, which can completely eliminate legacy substances, the expiry date  of the 
exemption  under the RoHS Directive  should be set with 28 May 2028 . 
                                                 
10 European Parliament resolution of 12 February 2020 on the draft Commission regulation amending Annex XVII to 
Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, 
Authorisation and Restriction of Chemicals (REACH) as regards lead and its compounds ( OJ C 294, 23.7.2021, p. 
2). 
11  Commission Regulation (EU) 2023/923 of 3 May 2023 amending Annex XVII to Regulation (EC) No 1907/2006 
of the Euro pean Parliament and of the Council as regards lead and its compounds in PVC (OJ L 123, 8.5.2023, p. 
1–6).  
EN 4  EN 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 III of Directive  2011/65/EU, for the use of cadmium  and 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 total negative 
environmental impacts caused by substitution are likely to outweigh the total environmental  
benefits.  
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 the 
RoHS  Directive 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.  
 
  
EN 5  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 cadmium and lead in plastic profiles in electrical and 
electronic windows and doors containing recovered polyvinyl chloride  
(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 o f 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 equipment1 and in particular Article 5(1) , point (a), thereof,  
Whereas:  
(1) Article 4(1) of Directive 201 1/65/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 
applications listed in Annex es III and 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  and lead are restricted substance s listed in Annex II to Directive 
2011/65/EU.  Lead  is restricted with a maximum concentration value of 0,1% and 
cadmium with a maximum concentration value of 0,01% by weight in homogenous 
materials.  
(4) On 14 December 2015, the Commission received an application made i n accordance 
with Article 5( 3) of Directive 2011/65/EU for granting an exemption  for cadmium  and 
lead in electrical and electronic windows and doors containing recovered polyvinyl 
chloride  (PVC)  ("the requested exemption") .  
(5) 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.  
(6) Cadmium and lead are used in recovered PVC  frame material for window and door 
sets for the purpose of polym er stabilisation of the PVC profiles . 
(7) The electrical and electronic equipment described in the requested exemption falls 
under category 11 of Annex I to Directive 2011/65/EU.  
                                                 
1 OJ L 174, 1.7.2011, p. 88.  
2  Study to assess 2 RoHS new exemption requests - #1 for cadmium in video cameras designed for use in 
environments exposed to ionising radiation, #2 for lead and cadmium in PVC profiles of electric 
windows and doors : final report    
EN 6  EN (8) While lead - and cadmium -free virgin PVC is available on the market , the use of 
recovered PVC  requires lower amount s of energy and natural resources (such as water, 
petroleum and natural salt) than the amounts that would be otherwise needed for the 
use of  virgin PVC . Therefore , the total negative environmental, health and consum er 
safety impacts  caused  by substitution would  likely outweigh the total environmental, 
health and consumer safety benefits thereof.  Thus, the requested exemption meets at 
least one of the relevant conditions specified in Article 5(1) , point (a), of Direct ive 
2011/65/EU.  
(9) The exemption does not weaken the environmental and health protection afforded by  
Regulation (EC) No 1907/2006 of the European Parliament and of the Council3. The 
scope of the exemption is limited to the current cadmium and lead restri ction  entries  
under th at Regulation. In particular, the scope of the exemption has been aligned with  
the derogation  for lead in recovered PVC set out in Commission Regulation (EU) 
2023/9234. 
(10) It is, therefore, appropriate to grant t he exemption by including the applications 
covered by that exemption  in Annex III to Directive 2011/65/EU with respect to 
electrical and electronic equipment of category 11 of Annex I to Directive 
2011/65/EU .  
(12) The expiry date of the exemption should be limited to 28 May 2028, by which the 
restriction entry 63, points 18, of Annex XVII to Regulation (EC) No 1907/2006  shall 
be reviewed. The expiry date is  in accordance with the first subparagraph of Article 
5(2) of Directive 2011/65/EU .  
(13) Directive 2011/65/EU should therefore be amended accordingly,   
 
HAS ADOPTED THIS DIRECTIVE:  
Article 1  
Annex III 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 [OP: please insert 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 communicate to the Commission the text of t hose provisions.  
They shall apply those provisions from [OP: please insert the last day of the 
sixth  month after the date of entry into force of this directive  + 1 day ]. 
                                                 
3 Regulation (EC) No 19 07/2006 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 , 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/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 
2000/21/EC  (OJ L 396, 30.12.2006, p. 1).  
4  Commission Regulation (EU) 2023/923 of 3 May 2023 amending Annex XVII to Regulation (EC) No 
1907/2006 of the European Parliament and of the Council as regards lead and its compounds in PVC  
(OJ L 123, 8.5.2023, p. 1 ).  
EN 7  EN 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 State s 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