G/TBT/N/EU/809  
29 June 2021  
(21-5216) 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/tb t/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; Electronic components in general (ICS 31.020)  
5. Title, number of pages and language(s) of the notified 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 the use of bis(2 -ethylhexyl) phthalate (DEHP) in 
ion-selective electrodes for analysing human body fluids and/or in dialysate fluids (7 
page(s), in English; 2 page(s), in English)  
6. Description of content:  This draft Commission Delegated Directive concerns an 
application specific and temporary exemption from the Directive 2011/65/EU (RoHS 2) 
substance restrictions.  
7. Objective and ratio nale, including the nature of urgent problems where 
applicable:  Adaptation of existing legislation to scientific and technical progress. The 
draft Commission Delegated Directive concerns a new exemption from substance 
restrictions due to apply from 22 July  2021. A shorter notification period is necessary to 
avoid potential negative impacts on medical facilities, which may be caused by a delay of 
granting the targeted exemption beyond the restrictions' entry into force date.; Protection 
of human health or sa fety; Protection of the environment  
8. Relevant documents:   
Scientific background studies justifying the specific exemption are available at 
https://op.europa.eu/en/publication -detail/ -/publication/df0ab036 -8b52-11ea-812f-
01aa75ed71a1/language -en/fo rmat-PDF/source -146143357 . G/TBT/N/EU/809  
 
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  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:  July 2021  
Proposed date of entry into force:  20 days from publication in the Official Journal of 
the EU (about 2 months after adoption approximately)  
10. Final date for comments:  15 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/2021/TBT/EEC/21_4400_00_e.pdf  
https://members.wto .org/crnattachments/2021/TBT/EEC/21_4400_01_e.pdf