G/TBT/N/EU/758  
                                                       18 November 2020  
(20-8256) 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/e n/  
3. Notified under Article 2.9.2 [   ], 2.10.1 [X], 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):  
Chemical  substances  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Regulation amending Annex XIV to Regulation (EU) No 1907/2006 of the 
European Parliament and of the Council as regards the substance group 4 -(1,1,3,3 -
Tetrameth ylbutyl)phenol, ethoxylated (covering well -defined substances and substances 
of unknown or variable composition, complex reaction products or biological materials, 
polymers and homologues) (7 page(s), in English)  
6. Description of content:  This draft Comm ission Regulation aims at amending entry 42 
of Annex XIV of the REACH Regulation. The draft proposes to amend the above -mentioned 
entry by postponing the latest application date and the sunset date, for uses of the 
substance OPE for the research, developme nt and production of medicinal products falling 
within the scope of Directive 2001/83/EC or medical devices or accessories to medical 
devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, 
Directive 98/79/EC or Regulation (EU) 2 017/746 of the European Parliament and of the 
Council, in view of their use for the diagnosis, treatment or prevention of the coronavirus 
disease (COVID -19); as well as uses in medical devices or accessories to medical devices 
falling within the scope of D irective 93/42/EEC, Regulation (EU) 2017/745, Directive 
98/79/EC or Regulation (EU) 2017/746 for the diagnosis, treatment or prevention of 
COVID -19, as follows:  
• latest application date: 18 months after entry into force of the draft Regulation;  
• sunset date: 36 months after entry into force of the draft Regulation.  G/TBT/N/EU/758  
 
- 2 - 
 
  7. Objective and rationale, including the nature of urgent problems where 
applicable:  The objective of this draft Regulation is to postpone the latest application 
date and the sunset date for  uses of the substance OPE for the research, development 
and production of medicinal products falling within the scope of Directive 2001/83/EC or 
medical devices or accessories to medical devices falling within the scope of 
Directive  93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 
2017/746 of the European Parliament and of the Council, in view of their use for the 
diagnosis, treatment or prevention of the coronavirus disease (COVID -19);as well as uses 
in medical devices or accesso ries to medical devices falling within the scope of Directive 
93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746 
for the diagnosis, treatment or prevention of COVID -19, in order to allow for such uses 
after 4  January 2021. In accordance with the provisions of Article 56(1) of REACH, uses 
of this substance are not allowed after the sunset date unless an authorisation has been 
granted for a particular use, an application for authorisation for a given use was submitted 
before t he latest application date but a decision on the application has not yet been taken 
or the use is covered by an exemption in accordance with the provisions of that 
Regulation. As the latest application date of 4 July 2019 passed before the onset of the 
COVID-19 pandemic, applications for authorisation for uses of that substance as detailed 
in the previous paragraph have not been submitted by that date and therefore such uses 
cannot lawfully continue after the sunset date; Other  
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).  
https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=CELEX%3A02006R1907 -
20140410  
9. Proposed date of adoption:  December 2020  
Proposed date of entry into force:  The day after publication in the Official Journal of 
the European Union  
10. Final date for comments:  nil.  
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/2020/TBT/EEC/20_7091_00_e.pdf  
https://members.wto.org/crnattachments/2020/TBT/EEC/20_7091_01_e.pdf