G/TBT/N/EU/946  
16 January 2023  
(23-0364) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
European Commission  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
European Comm ission,  
EU-TBT Enquiry Point,  
Fax: +(32) 2 299 80 43,  
E-mail: grow-eu-tbt@ec.europa.eu  
Website: http://ec.europa.eu/growth/tools -databases/tbt/en/  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CC CN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Electrical 
and electronic equipment (ICS – 31.020)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Del egated Directive 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 ; (7 pag e(s), in English), ( Annex - 2 page(s), in English)  
6. Description of content:  This draft Commission Delegated Directive concerns 
applications for a specific and temporary exemption from the RoHS 2 (Directive 
2011/65/EU) substance restrictions. The criteri a for a new exemption are met and it is 
proposed to grant a time -limited exemption in Annex IV of that Directive.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Adaptation of the Annexes to scientific and technical progress in order to 
allow innovation without compromising the objectives in Article 1 of the Directive 
2011/65/EU; Protection of human health or safety; Protection of the environment  
8. Relevant documents:   
A scientific background study evaluating the specific exemption is available at 
https://op.europa.eu/en/publication -detail /-/publication/49205318 -3249-11ed-975d-
01aa75ed71a1/language -en . G/TBT/N/EU/946  
 
- 2 - 
 
  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:  
http://eur -lex.europa.eu/legal -
content/EN/TXT/?qid=1438768100804&uri=CELEX:32011L0065  
9. Proposed date of adoption:  March 2023  
Proposed date of entry into force:  20 days from publication in the Official Journal of 
the EU (about three months after adoption approximately)  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
European Commission,  
EU-TBT Enquiry Point,  
Fax: + (32) 2 299 80 43,  
E-mail: grow-eu-tbt@ec.europa.eu  
The text is available on the EU -TBT Website : http://ec.europa.eu/growth/tools -
databases/tbt/en/  
https://members.wto.org/crnattachments/2023/TBT/EEC/23_0440_01_e.pdf  
https://members.wto.org/crnattachments/2023/TBT/EEC/23_0440_00_e.pdf