G/TBT/N/EU/343  
 
27 January 2016  
(16-0572)  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 telephon e 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 Commission 
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/  
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 applic able, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable): 
Z,Z,Z,Z-7,13,16,19-docosatetraen-1-yl isobutyrate (pesticide active substance) 
5. Title, number of pages and language(s) of the notified document: Draft Commission 
Implementing Regulation withdrawing the approval of the active substance 
Z,Z,Z,Z-7,13,16,19-docosatetraen-1-yl isobutyrate, in accordance with Regulation 
(EC)-No 1107/2009 of the European Parliament and of the Council, and amending Implementing Regulation (EU) No 54 0/2011 (4 pages, in English)  
6. Description of content: This draft Commission Implementing Regulation provides that 
the active substance Z,Z,Z,Z-7,13,16,19-docosatetraen-1-yl isobutyrate is withdrawn from the list of approved substances in accord ance with Regulation (EC) No 1107/2009 and 
cannot be placed on the market in plant pr otection products in the EU. Implementing 
Regulation (EU) No 2015/308 is repealed.
 
7. Objective and rationale, including the nature of urgent problems where 
applicable: In compliance with Article 6 of Regulation (EC) No 1107/2009 (concerning the 
placing of plant protection products on the ma rket), an active substance, complying with 
set criteria of approval, can be approved subject to conditions. During the evaluation and 
peer-review of the substance, a number of areas of the risk assessment could not be finalised and further studies were required as a condition of approval in implementing Regulation (EU) No 2015/308.  
However, the applicant did not submit the required studies within the set deadline and did 
not provide any justification. As the substance is currently approved in the EU it has to be withdrawn, allowing a period of grace for with drawal of any possible existing authorisations 
in compliance with Article 46 of Regulation (EC) No 1107/2009. To date no EU Member 
State informed the Commission on the current existence of any authorisation issued for a plant protection product containing the substance. G/TBT/N/EU/343 
 
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  8. Relevant documents:  
 Regulation (EC) No 1107/2009 of the Euro pean Parliament and of the Council of 
21 October 2009 concerning the placing of pl ant protection products on the market 
and repealing Council Directives 79/117/EEC and 91/414/EEC: http://eur-
lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:32009R1107&qid=1437730988988&from=EN  
 Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 
implementing Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council as regards the list of approved active substances (OJ L 153, 11.6.2011, 
p. 1–186 ) http://eur-lex.europa.eu/legal-
content/EN/TXT/?qid=1442928512004&uri=CELEX:32011R0540  
 Commission Implementing Regulation (EU) 2015/308 of 26 February 2015 amending 
Implementing Regulation (EU) No 540/2011 as  regards the conditions of approval of 
the active substance Z,Z,Z,Z-7,13,16,19-docosatetraen-1-yl isobutyrate ( OJ L 56, 
27.2.2015, p. 9–11 ): http://eur-lex.europa.eu/legal-
content/EN/TXT/?qid=1442928678752&uri=CELEX:32015R0308  
9. Proposed date of adoption: April 2016  
Proposed date of entry into force: 20 days from 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 Website: http://ec.europa.eu/growth/tools-databases/tbt/   
https://members. wto.org/crnattachments/2016/TBT/EEC/16_0331_00_e.pdf