EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/11584/2016 rev. 1  
[…](2018) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance flurtamone, in 
accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council concerning the placing of plant protection products on the market, and 
amending Commiss ion Implementing Regulation (EU) No 540/2011  
(Text with EEA relevance)   EN 1   EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning  the non -renewal of approval of the active substance flurtamone, in 
accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council concerning the placing of plant protection products on the market, and 
amending Commission Implem enting Regulation (EU) No 540/2011  
(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 Oc tober 2009 concerning the placing of plant protection products on the market 
and repealing Council Directives  79/11 7/EEC and 91/414/EEC1, and in particular 
Article  20(1)  and Article 78(2) thereof,  
Whereas:  
(1) Commission Directive 2003/84/EC2 included flurtamone as an active substance in 
Annex I to Council Directive 91/414/EEC3. 
(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 (EU) No  540/20114. 
(3) The approval of the active substance flurtamone , as set out in Part A of the Annex to 
Implementing Regulation (EU) No 540/2011 , expires on 31  October  2018 . 
(4) An application for the renewal of the approval of flurtamone  was submitted in 
accordance with Article 1 of Commission Implementing Regulation (EU) 
No 844/20125 within the time period provided for in that Article.  
(5) The applicant submitted the supplementary d ossiers required in accordance with 
Article  6 of Implementing Regulation (EU) No  844/2012 . The application was found 
to be complete by the rapporteur Member State.  
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Directive 2003/84/EC of 25 September 2003 amending Council Directive 91/414/EEC to 
include flurtamone, flufenacet, iodosulfuron, dimethenamid -p, picoxystrobin, fosthiazate and silthiofam 
as active substanc es (OJ L 247, 30.9.2003, p. 20).   
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 approved active 
substances (OJ L 153, 11.6.2011, p. 1).  
5 Commission Implementing Regulation (EU) No 844/2012  of 18 September 2012 setting out th e 
provisions necessary for the implementation of the renewal procedure for active substances, as provided 
for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the 
placing of plant protection products on the market  (OJ L 252, 19.9.2012, p. 26 ). EN 2   EN (6) The rapporteur Member State prepared a  renewal assessment report in consultation 
with the co -rapporteur Member State and submitted it to the European Foo d Safety 
Authority (  ‘the Aut hority’) and the Commission on 29 May 2015.  
(7) The Authority communicated the renewal assessment report to the applicant  and to the 
Member States for comments and forwar ded the comments received to the 
Commission. The Authority also made the supplementary summary dossier  available 
to the public.  
(8) On 10 August 2017  the Authority communicated  to the Commission its conclusion6 on 
whether flurtamone can be expected to meet the  approval criteria provided for in 
Article  4 of Regulation (EC) No  1107/2009.  
(9) The Autority identified specific concerns. In particular, it  concluded that it  is not 
possible to exclude the mutagenic potential of flurtamone based on the available 
information  and that no final health -based reference values could be set. Consequently, 
the Authority concluded that  the consumer and non -dietary risk asessements could not be 
conducted. In addition, the Authority concluded that the overall consumer risk 
assessment f or exposure to metabolite trifluoroacetic acid, predicted to occur in 
groundwater  in all pertinent scenarios  and as a residue  in plant s, could not be finalised 
due to a number of deficiencies in the dossier. Furthermore, the Authority concluded 
that the as sessment of endocrine disrupting properties could not be completed based on 
the available studies.  
(10) The Commission invited the applicant to submit its comments on the conclusion of the 
Authority  and, in accordance with the third subparagraph of Article  14(1) of 
Implementing Regulation (EC) No  844/2012, on the draft renewal report. The 
applicant submitted its comments, which have been carefully examined.  
(11) However, despite the arguments put forward by the applicant, the concerns regarding 
the active substance could not be eliminated.  
(12) Consequently, it has not been  established with respect to one or more representative 
uses of at least one plant protection product that the approval criteria provided for in 
Article  4 of Regulation (EC) No  1107/2009 are satisfied. It is therefore appropriate not 
to renew the approval of the active substance flurtamone  in accordance with 
Article  20(1)(b) of that Regulation . 
(13) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly.  
(14) Member States should be provi ded with sufficient time to withdraw authorisations for 
plant protection products containing flurtamone.  
(15) For plant protection products containing  flurtamone , where Member States grant any 
grace period in accordance with Article  46 of Regulation (EC) No  1107/2009, th at 
period should , at the latest,  expire  on [Office of Publications please insert date 
15 months from the date of entry into force] .  
(16) Commission  Implementing Regulation (EU) 2017/15117 extended  the expiry date of 
flurtamone  to 31 October  2018  in order to allow the renewal process to be completed 
                                                 
6 EFSA (European Food Safety Authority), 2017. Conclusion on the updated peer review of the pesticide 
risk assessment of the  active substance  flurtamone. EFSA Journal 2017;15(8):4976, 25 pp.  
https://doi.org/10.2903/j.efsa.2017.4976 . 
 EN 3   EN before the expiry of the approval of that substance. However, g iven that a decision is 
taken ahead of th at extended expiry date, this Regulation sh ould apply  as soon as 
possible . 
(17) This Regulation does not p revent  the submission of a further application for the 
approval of flurtamone  pursuant to Article 7 of Regulation (EC) No 1107/2009.  
(18) The measures provided for in this Regulation are in accordance with the opinion of the  
Standing Committee on Plant s, Animal s, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Non-renewal of approval of active substance  
The approval of the active substance flurtamone  is not renewed.   
Article 2  
Amendments to Implementing Regulation (EU) No 540/2011  
In Part A of the Annex to  Implementing Regulation (EU) No 540/2011, row 64, on 
flurtamone , is deleted.  
Article 3 
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
flurtamone as active substance by [ Office of Publications please insert date 6 months from the 
date of entry into force ] at the latest.  
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 possibl e and shall expire by [insert date 15 months  from the 
date of 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.  
                                                                                                                                                         
7 Commission Implementing Regulation (EU) 2017/1511 of 30 August 2017 amending Implementing 
Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances  
1-methylcyclopropene, beta -cyfluthrin, chlorothalonil, chlorotoluron, cypermethrin, daminozide, 
deltamethrin, dimethenamid -p, flufenacet, flurtamone, forchlorfenuron, fosthiazate, indoxacarb, 
iprodione, MCPA, MCPB, silthiofam, thiophanate -methyl and tribenuron  (OJ L 224, 31.8.2017, 
p. 115).  EN 4   EN Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER