EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11852/2015 
(POOL/E3/2015/11852/11852 -EN.doc)  
[…](2015) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
withdrawing the approval of the active substance Z -13-hexadecen -11-yn-1-yl acetate, in 
accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council, and amending Commission Implementing Regulation (EU) No 540/2011  
(Text with EEA relevance)    
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
withdrawing  the approval of the active substance Z -13-hexadecen -11-yn-1-yl acetate, in 
accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council, and amending Commission Implementing Regulation (EU) No 540/2011  
(Text with EEA relevanc e) 
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council of 21 October 2009 concerning the placing of plant protection prod ucts on the market 
and repealing Council Directives 79/117/EEC and 91/414/EEC1, and in particular the second 
alternative of Article 21(3) and Article 78(2) thereof,  
Whereas:  
(1) Commission Directive 2008/127/EC2 included Z-13-hexadecen -11-yn-1-yl acetate as  
active substance in Annex I to Council Directive 91/414/EEC  of 15 July 1991 
concerning the placing of plant pr otection products on the market3. Commission 
Implementing R egulation (EU) 2015/4184 requested the notifier to submit 
confirmatory information on the specification of the technical material, as 
commercially manufactured including information on any relevant impurities  by 
30 June 2015 .  
(2) Active substances included in Annex I to Directive 91/414/EEC are deemed to have 
been approved under Regulation (EC ) No 1107/2009 and are listed in Part A of the 
Annex to Commission Implementing Regulation (E U) No 540/20115. 
(3) The notifier did not submit the confirm atory information requested by the deadline of 
30 June 2015. By e -mail of 10 September 2015 it confirmed to  the Commission its 
intention not to submit such information.  
(4) Consequently, it is appropriate to withdraw the approval of Z-13-hexadecen -11-yn-1-
yl acetate.  
(5) The Annex to Implementing Regulation (EU) No 540/2011 should therefore be 
amended accordingly . 
                                                 
1 OJ L 309, 24.11.2009 , p. 1. 
2 Commission Directive 2008/127/EC  of 18 December 2008 amending Council Directive 91/414/EEC to 
include several active substances (OJ L 344, 20.12.2008, p. 89) . 
3 OJ L 230, 19.8.1991, p. 1 . 
4 Commission Implementing Regulation (EU) 2015/418 of 12 March 2015 amending Implementing 
Regulation  (EU) No 540/2011 as regards the conditions of approval of the active substance Z -13-
hexadecen -11-yn-1-yl acetate  (OJ L 68, 13.3.2015, p. 36 ). 
5 Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 amending implementing 
Regulation (EC) No 110 7/2009 of the European Parliament and of the  Council as regards the list of 
approved active substances (OJ L 153, 11.6.2011, p. 1).   
EN 3   EN (6) Mem ber States should be provided with time to withdraw authorisations for plant 
protection products containing Z-13-hexadecen -11-yn-1-yl acetate . 
(7) For plant protection products containing Z-13-hexadecen -11-yn-1-yl acetate , where 
Member States grant any grace p eriod in accordance with Article 46 of Regulation 
(EC) N o 1107/2009, that period should , at the latest, expire 18 months after entry into 
force  of this Regulation . 
(8) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Withdrawal of approval  
The approval of the active substance Z-13-hexadecen -11-yn-1-yl acetate  is withdrawn.  
Article 2 
Amendment to Commission Implementing Regulati on (EU) No 540/2011  
In Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011, row 258, 
Z-13-hexadecen -11-yn-1-yl acetate , is deleted.  
Article 3 
Transitional measures  
Member States shall withdraw authorisations for plant protection pro ducts containing Z-13-
hexadecen -11-yn-1-yl acetate  as active substance by [Office of Publications please insert date 
6 months after entry into force] . 
Article 4 
Grace period   
Any grace period granted by Member States in accordance with Article  46 of Regula tion (EC) 
No 1107/2009 shall be as short as possible and shall expire  on [Office of Publications please 
insert date 18 months after entry into force]  at the latest . 
Article 5 
Entry into force  
This Regulation shall enter into force on the twentieth  day following that of its publication in 
the Official Journal of the European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER