EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11851/2015 Rev. 1 
(POOL/E3/2015/11851/11851R1 -
EN.doc)  
[…](2016) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
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 540/2011  
(Text with EEA relevance)    
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
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 540/2011  
(Text with EEA rel evance)  
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  products 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,Z,Z,Z -7,13,16,19 -docosatetraen -1-yl 
isobutyrate 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 Regulation (EU) No 2015/3084 reques ted the notifier to 
submit confirmatory information on the specification of the technical material, as 
commercially manufactured, including information o n any relevant impurities by 
30 June 2015.  
(2) Active substances included in Annex I to Directive 91/414/E EC 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 confirmatory information requested by the deadline of 
30 June 2015 . After being informed by the Commission on the conseq uence of the 
lack of submission, t he applicant did not express intention to submit the required 
confirmatory information.  
(4) Consequently, it is appropriate to withdraw the approval of Z,Z,Z,Z -7,13,16,19 -
docosatetraen -1-yl isobutyrate . 
                                                 
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) 2015/308 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 ). 
5 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).  
EN 3   EN (5) The Annex to Implementing Regulation (EU) No 540/2011 should therefore be 
amended accordingly . 
(6) Member States should be provided with time to withdraw authorisations for plant 
protection products containing Z,Z,Z, Z-7,13,16,19 -docosatetraen -1-yl isobutyrate . 
(7) For plant protection products containing Z,Z,Z,Z -7,13,16,19 -docosatetraen -1-yl 
isobutyrate , where Member States grant any grace pe riod in accordance with 
Article  46 of Regulation (EC) N o 1107/2009, that period s hould , 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,Z,Z,Z -7,13,16,19 -docosatetraen -1-yl isobutyrate  is 
withdrawn.  
Article 2 
Amendment to Commission Implementing Regulation (EU) No 540/2011  
In Part A of the Annex to Implementing Regulation ( EU) No 540/2011, row 259, Z,Z,Z,Z -
7,13,16,19 -docosatetraen -1-yl isobutyrate , is deleted.  
Article 3 
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
Z,Z,Z,Z -7,13,16,19 -docosatetraen -1-yl isobutyrate  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 Regulation (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 Journa l of the European Union .  
EN 4   EN 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