G/TBT/N/EU/977  
4 May 2023  
(23-3122) 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):  medical 
devices  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Regulation amending Regulation (EC) No  1907/2006 of the European 
Parliament and of the Council as regards the substance bis(2 -ethylhexyl) phthalate 
(DEHP) in medical devices; (4 page(s), in English), (2 page(s), in English)  
6. Description of content:  Commission Regulation (EU) 2021/2045 of 23  November 2021 
(notified under G/TBT/N/EU/760) amended Annex XIV to Regulation (EC) No 1907/2006 
(REACH) by giving a Latest application date (LAD) regarding uses of Bis(2 -ethylhexyl) 
phthalate (DEHP) in medical devices until 27 November 2023 and a Sunset d ate (SD) 
until 27 May 2025.  
The draft Commission Regulation will extend the LAD for uses of bis(2 -ethylhexyl) 
phthalate (DEHP) in medical devices until 1 January 2029 and the SD until 1 July 2030. 
The draft Commission Regulation only extends the LAD and SD and does not contain any 
new requirements.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The objective of this draft Regulation is to align it with the new deadlines 
introduced by Regulation (EU) 2023/607 of the European Parliament and of the Council 
of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards 
the transitional provisions for certain medical devices and in vitro diagnostic medical 
devices (notified under G/TBT/N/EU/943)  G/TBT/N/EU/977  
 
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  8. Relevant documents:   
• Regulation (EC) No 1907/2006 of the European Parliament and of the Council on 
the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) 
(OJ L 396, 30.12.2006, p. 1) EUR-Lex - 32006R1907 - EN - EUR-Lex (europa.eu)  
• Commission Regulation (EU) 2021/2045 of 23 November 2021 amended Annex 
XIV to Regulation (EC) No 1907/2006 (REACH) by giving a Latest application date 
(LAD) regarding uses of Bis(2 -ethylhexyl) phthalate (DEHP) EUR-Lex - 
32021R2045 - EN - EUR-Lex (europa.eu)  
• Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 
March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regar ds 
the transitional provisions for certain medical devices and in vitro diagnostic 
medical devices (Text with EEA relevance) EUR-Lex - 32023R0607 - EN - EUR-
Lex (europa.eu)  
9. Proposed date of adoption:  September 2023  
Proposed date of entry into force:  1 day after publication in the Official Journal of the 
European Union  
10. Final date for comments:  10 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_09429_00_e.pdf  
https://members.wto.org/crnattachments/2023/TBT/EEC/23_09429_01_e.pdf