EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2022/2636 Rev 1  
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the approval of the active substance dimoxystrobin, in 
accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council, and amending Commission Implementing Regulation (EU) No 540/2011 and 
Commission  Implementing Regulation (EU) 2015/408  
(Text with EEA relevance)    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the approval of the active substance dimoxystrobin, in 
accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council, and amending Commission Implementing Regulation (EU) No 540/2011 and 
Commission Implementing Regulation (EU) 2015/408  
(Text with EEA relevance)  
THE EUROPEAN COMMISS ION,  
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  79/11 7/EEC and 91/414/EEC1, and in particular 
Article  20(1)  and Article 78(2) thereof,  
Whereas:  
(1) Commission Directive 2006/75/EC2 included dimoxystrobin  as an active substance in 
Annex I to Council Directive 91/414/EEC3. 
(2) According to Article 78(3) of Regulation (EC) No 1107/2009, a ctive 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 R egulation (EU) No  540/20114. 
(3) The approval of the active substance dimoxystrobin , as set out in Part A of the Annex 
to Implementing Regulation (EU) No 540/2011 , expires on 31 January  2024 . 
(4) An application for the renewal of the approval of the active substan ce dimoxystrobin  
was submitted to Hungary, the rapporteur Member State, and Ireland, the co -
rapporteur Member State, in accordance with Article 1 of Commission Implementing 
Regulation (E U) No 844/20125 within the time period provided for in that Article.  
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Directive 2006/75/EC of 11 September 2006 amending Council Directive 91/414/EEC to 
include dimoxystrobin as active substance (OJ L 248, 12.9.2006, p. 3).  
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. 2006 , p. 1).  
4 Commission Implementing Reg ulation (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 the 
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 o f plant protection products on the market  (OJ L 252, 19.9.2012, p. 26 ). This Regulation was 
replaced by Regulation (EU) 2020/1740, however, it continues to apply to the procedure for the renewal 
of the approval of active substances: (1) whose approval peri od ends before 27 March 2024; (2) for 
  
EN 2  EN (5) The applicant submitted the supplementary dossiers required by Article 6 of 
Implementing Regulation (EU) No 844/2012  to the rapporteur Member State, the co -
rapporteur Member State, the Commission and the European Food Safety Authority 
(‘the Authority’) . The application was found to be complete by the rapporteur Member 
State.  
(6) The rapporteur Member State prepared a draft renewal assessment report in 
consultation with the co -rapporteur Member State and submitted it to the Authority  
and the Commission on 1 September  2017 . In its draft renewal assessment report, the 
rapporteur Member S tate proposed to renew the approval of the active substance 
dimoxystrobin.  
(7) The Authority made the supplementary summary dossier available to the public. The 
Authority also circulate d the draft renewal assessment report to the applicant and to 
the Member States for comments and launched a public consultation on it. The 
Authority forwarded the comments received to the Commission.  
(8) The Authority conducted expert consultation s in the areas of mammalian toxicology, 
environmental fate and behaviou r, and ecotoxicology in January  and June 2022. As a 
result of those consultations  the Authority identified concerns, in particular in relation 
to groundwater contamination by toxicologic ally relevant metabolites of 
dimoxystrobin.  
(9) On 12 August 2022, i n the light of the concern  in relation to groundwater 
contamination identified by the Authority , the Commission requested  the Authority to 
issue a statement containing a summary of its main fi ndings as regards the assessment  
of the active substance  dimoxystrobin in relation to its environmental fate , its 
behaviour and its ecotoxicology.  
(10) On 11 October 2022 , the Authority communicated that statement to the Commission6. 
(11) In its statement, the Authority confirmed that a critical area of concern exist s for all the 
representative uses  of the active substance, in particular  a high potential for 
groundwater contamination by toxicologically relevant metabolites  of dimoxystrobin  
(505M08 and 505M09 ) in all geoclimatic conditions represented by the groundwater 
assessment scenarios . 
(12) The Commission presented its draft renewal  report regarding dimoxystrobin  and a draft 
of this Regulation to the Standing Committee on Plant s, Animals, Food and Feed  on 
8 December  2022  and on 25  January  2023, respectively . 
(13) The Commission invited the applicant to submit its comments on the statement  of the 
Authority. Furthermore, in accordance with Article 14(1) , third subparagraph,  of 
Implementing Regulat ion (EU) No  844/2012, the Commission invited the applicant to 
submit comments on the draft renewal report. The applicant submitted its comments, 
which have been carefully examined.  
                                                                                                                                                         
which a Regulation, adopted in accordance with Article 17 of Regulation (EC) No 1107/2009 on or 
after 27 March 2021, extends the approval period to 27 March 2024 or a later date.  
6 EFSA (European Food Safety Authority), 2022. Statement concerning the assessment of environmental 
fate and behaviour and ecotoxicology in the context of the pesticides peer review of the active substance 
dimoxystrobin. EFSA Journal 2022; 20(11): e07634 https://doi.org/10.2903/j.efsa.2022.7634 .  
EN 3  EN (14) Despite the arguments put forward by the applicant, the concerns related to  the 
environmental fate, behaviour and ecotoxicology of dimoxystrobin could not be 
eliminated.  
(15) Consequently, it has not been  established that dimoxystrobin fulfils the approval 
criteria provided for in Article 4 of Regulation (EC) No  1107/2009 . It is therefore 
appropriate not to renew the approval of that active substance . 
(16) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly.  
(17) Commission Implementing Regulation (EU) 2015/4087 listed dimoxystrobin  as a 
candidate for subs titution. In the light of the non -renewal of the approval of 
dimoxystrobin  that listing is no longer relevant. Accordingly, dimoxystrobin  should be 
deleted from the Annex to Implementing Regulation (EU) 2015/408.  
(18) Member States should be given  time to withd raw authorisations for plant protection 
products containing dimoxystrobin . 
(19) For plant protection products containing dimoxystrobin , where Member States grant a 
grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that 
period should  not exceed 12 months  from the date of entry into force of this 
Regulation . 
(20) Commission Implementing Regulation (EU) 2023 /1158 extended the approval period  
of dimoxystrobin  to 31 January 2024  in order to allow the renewal process to be 
completed before the expiry of the approval period . However, g iven that a decision on 
the non -renewal of the approval has been  taken ahead of the expiry of that extended 
approval period , this Regulation should apply earlier than that date . 
(21) This Regulation do es not prevent  the submission of another  application for the 
approval of dimoxystrobin  pursuant to  Article 7 of Regulation (EC) No 1107/2009.  
(22) The measures provided for in this Regulation are in accordance with the opinion of the  
Standing Committee on Plant s, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Non-renewal of the approval of the active substance  
The approval of the active substance dimoxystrobin  is not renewed.   
Article 2 
Amendment  to Implementing Regulation (EU) No 540/2011  
In Par t A of the Annex to Implementing Regulation (EU) No 540/2011, row 128 on 
                                                 
7 Commission Implementing Regulation (EU) 2015/408 of 11 March 2015 on implementing Article 
80(7) of Regulation (EC) No 1107/2009 of the European Parliament and  of the Council concerning the 
placing of plant protection products on the market and establishing a list of candidates for substitution. 
(OJ L 67, 12.3.2015, p. 18) .  
8 Commission Implementing Regulation (EU) 2023/115 of 16 January 2023 amending Implement ing 
Regulation (EU) No 540/2011 as regards the extension of the approval period of the active substance 
dimoxystrobin . (OJ L 15, 17.1.2023, p. 13).  
EN 4  EN dimoxystrobin  is deleted.  
Article 3  
Amendment to Implementing Regulation (EU) 2015/408  
The entry for dimoxystrobin  in the Annex to Implementing Regulation (EU) 2015/408  is 
deleted . 
Article 4  
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
dimoxystrobin  as an active substance by  … [Office of Publications please insert date 6 
months from the date of entry into force  of this Regulation ]. 
Article 5  
Grace period  
Any grace period granted by Member States in accordance with Article 46 of Regulation (EC)  
No 1107/2009 shall expire by  … [Office of Publications please insert date 1 2 months from 
the date of entry into force  of this Regulation ]. 
Article 6  
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 appli cable in all Member States.  
Done at Brussels,  
 For the  Commission  
 The President  
 Ursula VON DER LEYEN