EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/11865/2015 Rev. 2 […](2015) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
concerning the non-approval of the active s ubstance tricyclazole, in accordance with 
Regulation (EC) No 1107/2009 of the Euro pean Parliament an d 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 tricyclazole, 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 
21 December 2012, Italy received an app lication from Dow Ag roSciences for the 
approval of the active substance tricyclazole. 
(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 4 February 2013. 
(3) For that active substance, the effects on hum an and animal health and the environment 
have been assessed, in accordance with the provisions of Article 11(2) and (3) of that 
Regulation, for the use proposed by the ap plicant. The rapporteur Member State 
submitted a draft assessment report to the Commission and the Authority on 
7 January 2014. 
(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 tricyclazole
2 on 18 February 2015. The Authority concluded that 
the assessment of the genot oxic and carcinogenic potent ial of the substance was 
inconclusive and therefore reference values  (ADI, ARfD and AOEL) for use in human 
health risk assessments could not be esta blished. Consequently, the risk assessments 
for operators, workers, bystanders, residents and consumers could not be conducted. It 
                                                 
1 OJ L 309, 24.11.2009, p. 1. 
2 EFSA Journal 2015;13(2):4032 Available online: www.efsa.europa.eu/efsajournal . 
 EN 3   EN further concluded that the test material  used in the toxicity studies was not 
representative of the proposed technical specification for the active substance and 
associated impurities. In addition, certain areas of the assessment could not be finalised, including the potential  of tricyclazole to act as  an endocrine disruptor and 
the potential for groundwater  contamination by metabolites whose toxicological 
relevance is unknown.  
(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 
tricyclazole, the approval criteria provi ded for in Article 4 of Regulation (EC) 
No 1107/2009 are satisfied. The active substanc e tricyclazole should therefore not be 
approved pursuant to Article 13 (2) of Regulation (EC) No 1107/2009. 
(9) This Regulation does not prejudice the su bmission of a further application for 
tricyclazole 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 Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Non-approval of active substance 
The active substance tricycl azole 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