EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11619/2016  
[…](2016) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending Implementing Regulation (EU) No 540/2011 as regards the conditions of 
approval of the active substance abamectin  
(Text with EEA relevance)    
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending  Implementing Regulation (EU) No 540/2011 as regards the conditions of 
approval of the active substance abamectin  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to Regu lation (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  
Article  13(2) thereof , 
Whereas:  
(1) Commission Directive  2008/107/EC2 included  the active substance abamectin  as an 
active substance in Annex I to Council Directive 91/414/EEC3 for uses as an acaricide 
and as an insecticide.  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 (EU) No  540/20114. 
(2) In accordance with Article 7(1) of Regulation (EC) No 1107/2009, on 29 August 2013  
the producer  of the active substance Syngenta Crop Protection AG  submitted an 
application to the designated rapporteur Member State The Netherlands seeking an 
amendment to the conditions of approval of abamectin in order to provide for its use 
as a nemati cide. In accordance with Article  9(3) of that Regulation, The Netherlands  
notified the applicant, the other Member States, the European Food Safety Authority 
(hereinafter 'the Authority' ) and the Commission on 18  March  2014 that the 
application was admissi ble. 
(3) The designated rapporteur Member State assessed the new use of the active substance 
abamectin in relation to potential effects on human and animal health and the 
environment in accordance with the provisions of Article  4 of Regulation (EC) 
No 1107/2009 , and submitted a draft assessment report to the Commission and to the 
Authority on 14 April  2015 . In accordance with Article  12(3) of that Regulation 
additional information was requested from the applicant. The Netherlands evaluated 
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Directive 2008/107/EC of 25 November 2008 amending Council  Directive 91/414/EEC to 
include abamectin, epoxiconazole, fenpropimorph, fenpyroximate and tralkoxydim as active substances  
(OJ L 316, 2 6.11.2008, p. 4) . 
3 Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on  
the market (OJ L 230, 19.8.1991, p. 1).  
4 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 approv ed active 
substances (OJ L 15 3, 11.6.2011, p. 1 ).  
EN 3   EN the additiona l information and submitted an up dated draft assessment report to the 
Commission and to the Authority in 15 February  2016 . 
(4) On 29 April 2016 the Authority communicated to the Commission its conclusion5 on 
whether the new uses of the active substance abamect in can be expected to meet the 
approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The 
Commission presented the draft addendum to the review report for abamectin  and a 
draft Regulation to the Standing Committee on Plants, Animals, Food and Feed on 
7 December  2016 . 
(5) The applicant was invited to submit comments on the review report.  
(6) It has been established with respect to one or more representative uses of at least one 
plant protection product  containing  the active substance  that, when th e plant protection 
product is used as a nematicide , the approval criteria provided for in Article 4 of 
Regulation (EC) No  1107/2009 are satisfied. It is therefore appropriate to allow the 
use of the active substance abamectin as a nematicide . 
(7) In ac cordance with Article  13(2) of Regulation (EC) No  1107/2009 in conjunction 
with Article  6 thereof and in light of current scientific and technical knowledge, it is 
necessary and appropriate to grant approval subject to certain conditions  and to require 
the applicant to provide further confirmatory information.  
(8) The approval of abamectin provided that some confirmatory data shall be submitted 
within two years after the entry into force of Commission Directive 2008/107/EC. The 
applicant at which request abamec tin was approved submitted the requested 
information, which was assessed by The Netherlands. These confirmatory information 
confirmed the safe uses identified in the first assessment and shall be considered as 
fully addressed. Therefore, there is no need t o pertain them.  
(9) The Annex to Implementing Regulation (EU) No 540/2011 should therefore be 
amended accordingly.  
(10) 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  
Amendment to Implementing Regulation (EU) No 540/2011  
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the 
Annex to this Regulation.  
Article 2 
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.  
                                                 
5 EFSA Journal 2014;12( 5):3692. Available online: www.efsa.europa.eu .  
EN 4   EN Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUN CKER