EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/1037  
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the approval of the active substance clofentezine, 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  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the approval of the active substance clofentezine, 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  
(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  79/11 7/EEC and 91/414/EEC1, and in particular 
Article  20(1)   and Article 78(2) thereof,  
Whereas:  
(1) Commission Directive 2010/39/EU2 included clofentezine  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 clofentezine , as set out in Part A of the Annex to 
Impl ementing Regulation (EU) No 540/2011 , expires on 31 December  2023 . 
(4) An application for the renewal of the approval of the active substance clofentezine  was 
submitted to Spain , the rapporteur Member State, and the Netherlands , 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 2010/39/EU of 22 June 2010 amending Annex I to Council Directive 
91/414/EEC as regards the specific provisions relating to the active substances clofentezine, 
diflubenzuron, lenacil, oxadiazon, picloram and pyriproxyfen  (OJ L 156, 23.6.2010, p. 7 ). 
3 Council Directive 9 1/414/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 Parliame nt 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 proce dure 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) , which continues to 
apply to the proced ure for the renewal of the approval of t his active substance pursuant to Article 17 of 
Commission Implementing Regulation (EU) 2020/1740 of 20 November 2020 setting out the provisions 
necessary for the implementation of the renewal procedure for active sub stances, as provided for in 
 EN 2  EN (5) The applicant submitted the supplementary dossiers required  to the rapporteur 
Member State, the co -rapporteur Member State, the Commission and the European 
Food Safety Authority (‘the Authority’)  in accordance with Article 6 of Implementing 
Regulation (EU) No 844/2012. The application was found to be admissible  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 6 March 2018 . In its draft renewal assessment report , the 
rapporteur Member State  proposed that the approval of clofentezine could only be 
renewed if the applicant submitted additional data to further address certain issues 
during the subsequent peer review process.  
(7) The Authority made the supplementa ry summary dossier available to the public. The 
Authority also circulated 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) In accordance with Article 13(3a) , third subparagraph,  of Implementing Regulation 
(EU) No  844/2012 , the applicant was given the opportunity to submit additional 
information to address the approval criteria concerning endocrine disrupting properties 
set out in point 3.6.5 and point 3.8.2 of Annex II to Regulation (EC) No 1107/2009.  
(9) On 29 July 2021 , the Authority communicated  to the Commission its conclusion6 on 
whether clofentezine  can be expected to meet th e approval c riteria provided for in 
Article  4 of Regulation (EC) No  1107/2009.  
(10) In its conclusion, t he Authority ident ified several  concerns . In particular, it concluded that 
based on the available information submitted in the dossier, clofentezine has endocrine 
disrupting properties that may cause adverse effects in humans , as set out in point 3.6.5 
of Annex II to Regulation (EC) No 1107/2009 . According to the Authority, r esidues of  
clofentezine are expected to be  above  the value set in  point  3.6.5 of Annex II to 
Regulation (EC) No 1107/2009 . Therefore, the requirement  set out in point 3.6.5 of  
Annex II to Regulation (EC) No  1107/2009 is not fulfilled.  
(11) Furthermore, the Authority identified a high long-term risk to birds and wild mammals 
for the representative uses not grown in permanent greenhouses . The Authority also 
concluded that the consumer risk assessment could not be performed and that 
maximum residue levels could not be proposed based on the available  data and that the 
risk assess ment for non -target arthropods could also not be finalised  for the 
representative uses not grown in permanent greenhouses .  
(12) In its evaluation of whether clofentezine  is necessary to control a serious danger to 
plant health which cannot be contained by othe r available means including non -
chemical methods  in accordance with Art icle 4(7) of Regulation (EC) No  1107/2009, 
the Authority  concluded that, despite the fact that there may be an insufficient number 
of chemical alternatives available for some uses of clofentezine and in some Member 
States, some non -chemical methods are also available, and that a combination of 
chemical and non -chemical methods may be possible to con trol the pests in some 
                                                                                                                                                         
Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and repealing 
Commission Implementing Regulation (EU) No 844/2012 (OJ L 392, 23.11.2020, p. 20) .  
6 Conclusion on the peer review of the pesticide  risk assessment of the active substance clofentezine  
(EFSA Journal 2021;19(8):6817 ; https://doi.org/10.2903/j.efsa.2021.6817 ). EN 3  EN crops. In addition, no serious danger to plant health has been identified.  Therefore, the 
Commission considers that the conditions for the application of the derogation in 
Article  4(7) of Regulation (EC) No 1107/2009 are not fulfille d. 
(13) The Commission presented a renewal report on 24 May 2023  and a dr aft of this 
Regulation to the Standing Committee on Plant s, Animals, Food and Feed  on 
12 July 2023 . 
(14) The Commission invited the applicant to submit its comments on the conclusion of the 
Authority. Furthermore, in accordance with Article  14(1) , third subparagraph,  of 
Implementing Regulation (EU) No 844/2012, the Commission invited the applicant to 
submit comments on the renewal report. The applicant submitted its comments, which 
have been carefully examined.  
(15) Despite the arguments put forward by the applicant, the concerns regarding the active 
substance  could not be eliminated.  
(16) Consequently, it has not been  established with respect to one or more representative 
uses of at least one plant pr otection 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 clofentezine  in accordance with 
Article  20(1) , point (b), of that Regulation . 
(17) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly.  
(18) Member States should be given  sufficient  time to withdraw authorisations for plant 
protection products containing clofentezine.  
(19) For plant protection products  containing clofentezine , where  Member States grant any 
grace period in accordance with Article  46 of Regulation (EC) No 1107/2009, t hat 
period should  not exceed 12 months  from the date of entry into force of this 
Regulation . Commission Implementing Regulation (EU) 2022/14807 extended the 
approval period  of clofentezine  to 31 December 2023  in order to allow the renewal 
process to be co mpleted before the expiry of the approval period  of that active 
substance .  
(20) Taking into account that the current approval of clofentezine  expires on 31 December 
2023 , this Regulation should enter into force as soon as possible.  
(21) This Regulation does not prevent  the submission of another  application for the 
approval of clofentezine  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 , 
                                                 
7 Commission Implementing Regulation (EU) 2022/1480 of 7  September 2022 amending Implementing 
Regulation (EU) No  540/2011 as regards the extension of the approval periods of the active substances 
2-phenylphenol (including its salts such as the sodium salt), 8 -hydroxyquinoline, amidosulfuron, 
bensulfuron, bifenox, chlormequat, chlorotoluron, clofentezine, clomazone, daminozide, deltamethrin, 
dicamba, difenoconazole, diflufenican, dimethachlor, esfenvalerate, etofenprox, fenoxaprop -P, 
fenpropidin, fenpyrazamine, fludioxonil, flufenacet, flumetralin, fosthiazate, lenacil, MCPA, MC PB, 
nicosulfuron, paraffin oils, paraffin oil, penconazole, picloram, prohexadione, propaquizafop, 
prosulfocarb, quizalofop -P-ethyl, quizalofop -P-tefuryl, sodi um 5 -nitroguaiacolate, sodium 
o-nitrophenolate, sodium p -nitrophenolate, sulphur, tebufenpyrad, t etraconazole, tri -allate, triflusulfuron 
and tritosulfuron ( OJ L 233, 8.9.2022, p. 43).  
 EN 4  EN HAS ADOPTED THIS REGULATION:  
Article 1  
Non-renewal of the approval of the active substance  
The approval of the active substance clofentezine  is not renewed.   
Article 2 
Amendment  to Implementing Regulation (EU) No 540/2011  
In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 171 on 
clofentezine  is deleted.  
Article 3 
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
clofentezine  as an active substance by … [Office of Publications : please insert date 6 months 
from the date of entry into force  of this  Implementing Regulation ]. 
Article 4 
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 12 months from  
the date of entry into force  of this Implementing Regulation ].  
Article 5 
Entry into force  
This Regulation shall enter into force on the third 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  
 Ursula VON DER LEYEN