EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10446/2015 Rev. 2 […](2015) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
concerning the non-approval of the active substance 3-decen-2-one, in accordance with 
Regulation (EC) No 1107/2 009 of the European Parlia ment and of the Council 
concerning the placing of plant protection products on the market 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
concerning the non-approval of the active s ubstance 3-decen-2-one, in accordance with 
Regulation (EC) No 1107/2009 of the Euro pean Parliament and of the Council 
concerning the placing of plant pr otection products on the market 
(Text with EEA relevance) 
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/EEC
1, and in particular 
Article 13(2) thereof, 
Whereas: (1) In accordance with Article 7(1) of Regulation (EC) No 1107/2009, on 
14 September 2011 the Netherlands receive d an application from AMVAC C.V (now 
AMVAC Netherlands B.V) for the approval of the active substance 3-decen-2-one. 
(2) In accordance with Article 9(3) of that  Regulation, the rapporteur Member State 
notified the applicant, the other Member States, the Commission and the European 
Food Safety Authority (hereinafter 'the Authority') of the admissibility of the application on 13 April 2012.  
(3) For that active substance, the effects on hum an and animal health and the environment 
have been assessed, in accordance with Artic le 11(2) and (3) of that Regulation, for 
the use proposed by the applicant. The rapporteur Member State submitted a draft assessment report to the Commission a nd the Authority on 26 November 2013. 
(4) The Authority complied with Article 12( 1) of Regulation (EC) No 1107/2009. In 
accordance with Article 12(3) of  that Regulation, it requested that the applicant supply 
additional information to the Member Stat es, the Commission and the Authority. The 
assessment of the additional informati on by the rapporteur Member State was 
submitted to the Authority in the format of an updated draft assessment report.  
(5) The draft assessment report was reviewed by the Member States and the Authority. 
The Authority presented to the Commission its conclusion on the risk assessment of 
the active substance 3-decen-2-one
2 on 3 December 2014. The Authority concluded 
that the presence of positive genotoxicity re sults and the limited toxicological data 
package prevented final toxicological refe rence values from being established and 
therefore the risk assessment for operato rs, workers, bystanders, residents and 
consumers could not be completed.  It furt her concluded that the evaluation of the 
MRL application with the request to exem pt 3-decen-2-one from MRL setting could 
                                                 
1 OJ L 309, 24.11.2009, p. 1. 
2 EFSA Journal 2015;13(1):3932 Available online: www.efsa.europa.eu/efsajournal . 
  
EN 3   EN not be finalised, since the available informa tion is insufficient to conclude on whether 
use of 3-decen-2-one as an active substanc e in plant protection products will have no 
immediate or delayed harmful effects on hum an health, including that of vulnerable 
groups, through dietary intakes. 
(6) The Commission invited the applicant to s ubmit its comments on the conclusion of the 
Authority and, in accordance with Article 13(1) of Regulation (EC) No 1107/2009, on 
the draft review report. Th e applicant submitted its comments, which have been 
carefully examined. 
(7) However, despite the arguments put forward by the applicant, the concerns referred to 
in recital 5 could not  be eliminated.  
(8) Consequently, it has not been demonstrated th at it may be expected that, with respect 
to one or more representative uses of at  least one plant protection product containing 
3-decen-2-one, the approval criteria provide d for in Article 4 of Regulation (EC) 
No 1107/2009 are satisfied. The active substa nce 3-decen-2-one should therefore not 
be approved pursuant to Article 13( 2) of Regulation (EC) No 1107/2009. 
(9) This Regulation does not prejudice the submissi on of a further application for 3-decen-
2-one pursuant to Article 7 of  Regulation (EC) No 1107/2009.  
(10) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Plant, Animals, Food and Feed, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Non-approval of active substance 
The active substance 3-decen-2-one is not approved.  
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. 
Done at Brussels, 
 For the Commission 
 The President  Jean-Claude JUNCKER