G/TBT/N/EU/806  
18 June 2021  
(21-4997) 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):  Chemical 
substances; Products of the chemical industry (ICS 71.100)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Regulation amending Annex XIV to Regulation (EC) No 1907/2006 of the 
European Parliament and of the C ouncil concerning the Registration, Evaluation, 
Authorisation and Restriction of Chemicals (REACH) (6 page(s), in English; 3 page(s), in 
English)  
6. Description of content:  This draft Commission Regulation aims at amending Annex XIV 
of the REACH Regulatio n. Annex XIV lists the substances that are subject to the 
authorisation requirement laid down in Title VII of that Regulation. The draft proposes to 
include 5 additional substances in that Annex, namely:  
−    Tetraethyllead;  
−    4,4'-bis(dimethylamino) -4''-(methylamino)trityl alcohol [with ≥ 0.1% of Michler's 
ketone (EC No. 202 -027-5) or Michler's base (EC No. 202 -959-2)]; 
−    Reaction products of 1,3,4 -thiadiazolidine -2,5-dithione, formaldehyde and 4 -
heptylphenol, branched and l inear (RP -HP) [with ≥0.1% w/w 4 -heptylphenol, branched 
and linear];  
−    2-ethylhexyl 10 -ethyl-4,4-dioctyl -7-oxo-8-oxa-3,5-dithia -4-stannatetradecanoate 
(DOTE);  
−    Reaction mass of 2 -ethylhexyl 10 -ethyl-4,4-dioctyl -7-oxo-8-oxa-3,5-dithia -4-
stannatetradec anoate and 2 -ethylhexyl 10 -ethyl-4-[[2-[(2-ethylhexyl)oxy] -2-
oxoethyl]thio] -4-octyl-7-oxo-8-oxa-3,5-dithia -4-stannatetradecanoate (reaction mass of 
DOTE and MOTE).  G/TBT/N/EU/806  
 
- 2 - 
 
  Once the regulation is adopted and enters into force, the placing on the market and the 
use of those substances in the EU will only be possible, after the date specified for each 
substance ("sunset date"), for those operators who have been granted an authorisation 
in accordance with Articles 60 -64 of REACH, and for those who have submitted an 
application for authorisation before a given date ("latest application date") but a decision 
has not yet been adopted.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The objective of this draft Regulation is to subject 5 substances of very high 
concern to the authorisation requirement laid down in the REACH Regulation. According 
to Article 55 of that Regulation, the aim of the authorisation provisions is "to ensure the 
good functioning of the internal market while assuri ng that the risks from substances of 
very high concern are properly controlled and that these substances are progressively 
replaced by suitable alternative substances or technologies where these are economically 
and technically viable." ; Protection of huma n health or safety; Protection of the 
environment  
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)  
http://eur -lex.europa.eu/legal -
content/EN/TXT/?qid=1423064258789&uri=CELEX:32006R1907  
9. Proposed date of adoption:  February 2022  
Proposed date of entry into force:  20 days after publication in the Official Journal of 
the European Union  
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/2021/TBT/EEC/21_4219_00_e.pdf  
https://members.wto .org/crnattachments/2021/TBT/EEC/21_4219_01_e.pdf