G/TBT/N/EU/678  
4 September 2019  
(19-5685) 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 Commission  
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 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Electrical 
and electronic equipment  
5. Title, number of pages and language(s) of the noti fied document:  Draft 
Commission Delegated Directive 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 lead as a thermal st abiliser in polyvinyl chloride 
used in certain in -vitro diagnostic medical devices for the analysis of blood and other body 
fluids and body gases (7 pages + Annex 2 pages, in English)  
6. Description of content:  This draft Commission Delegated Directive concerns an 
application specific and temporary exemption from the RoHS 2 (Directive 2011/65/EU) 
substance restrictions.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Adapta tion of existing legislation to scientific and technical progress, granting 
manufacturers adequate transition time for compliance  
8. Relevant documents:   
• Scientific background studies justifying the specific exemption are available 
(https://publications.europa.eu/en/publication -detail/ -/publication/33a336f0 -
e0ef-11e8-b690-01aa75ed71a1/language -en/format -PDF/source -84895526 ). 
• 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  G/TBT/N/EU/678  
 
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  9. Proposed date of adoption:  November 2019  
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/2019/TBT/EEC/19_4880_00_e.pdf  
https://members.wto.org/crnattachments/2019/TBT/EEC/19_4880_01_e.pdf