G/TBT/N/EU/808  
29 June 2021  
(21-5215) 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), 
butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in 
spare parts recovered from and used for the repair or refurbishment of medical devices 
(7 page(s), in English; 2 page(s), in English)  
6. Description of content:  This draft Commission Delegated Directive concerns an 
application to grant a new specific and te mporary exemption from the Directive 
2011/65/EU (RoHS 2) substance restrictions.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Adaptation of existing legislation to scientific and technical progress. The 
draft Commi ssion 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 safety; Protection of the environment  
8. Relevant documents:   
Scientific background studies justifying the specific exemption are available  
https://op.europa.eu/en/pub lication -detail/ -/publication/df0ab036 -8b52-11ea-812f-
01aa75ed71a1/language -en/format -PDF/source -146143357  G/TBT/N/EU/808  
 
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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 el ectrical and electronic 
equipment:  
http://eur -lex.europ a.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 three 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 _4399_00_e.pdf  
https://members.wto.org/crnattachments/2021/TBT/EEC/21_4399_01_e.pdf