EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2022/2562 CIS Rev. 1  
[…](2022) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
withdrawing the approval of the active substance ipconazole in accordance with 
Regulation (EC) No 1107/2009 of the European Parliament and of the Council, 
amending Commission Implementing Regulation (EU) No 540/2011 and repealing 
Commission Implementing Re gulation (EU) No 571/2014  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
withdrawing the approval of the active substance ipconazole in accordance with 
Regulation (EC) No  1107/2009 of the European Parliament and of the Council, 
amending Commission Implementing Regulation (EU) No 540/2011 and repealing 
Commission Implementing Regulation (EU) No 571/2014  
(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 Directi ves 79/117/EEC and 91/414/EEC1, and in particular 
Article  21(3) and Article 78(2)  thereof,  
Whereas:  
(1) Commission Implementing Regulation  (EU) No 571/20142 approved  ipconazole  as an 
active substance in accordance with Regulation (EC) No  1107/2009  and listed it in 
Part B of the Annex to Commission Implement ing Regulation (EU) No 540/20113. 
(2) Following the submission of confirmatory data on the long -term risk to g ranivorous 
birds, as required by Article 1 in conjunction with Annex I to  Implementing 
Regulation (EU) No 571/2014, the original rapporteur Member State, the United 
Kingdom4, carried out an evaluation of the data , which was reviewed by Member  
States and the European Food Safety Authority (‘the Authority’) . Based on the 
information submitted, t he Authority  concluded that there is a high long-term risk to 
birds for the representative use s of ipconazole5. 
(3) On 9 March 2018 , the Committee  for Risk Assessment  of the European Chemicals 
Agency adopted an opinion6 in accordance with Arti cle 37(4) of Regulation (EC) 
                                                 
1 OJ L 309, 24.11.2009 , p. 1. 
2 Commission Implementing Regulation (EU) No 571/2014 of 26 May 2014 approving the active 
substance ipconazole, 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 the 
Annex to Commission Implementing Regulation (EU) No  540/2011 ( OJ L 157, 27.5.2014 , p. 96).   
3 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) . 
4 Followi ng the withdrawal of  the United Kingdom from the Union, Belgium was designated as the 
rapporteur Member State for ipconazole by Commission Implementing Regulation (EU) 2018/155 of 31 
January 2018 amending Implementing Regulation (EU) No 686/2012 allocating  to Member States, for 
the purposes of the renewal procedure, the evaluation of active substances  (OJ L 29, 1.2.2018, p.  8).  
5 EFSA (European Food Safety Authority),  2017.  Technical report on the outcome of the consultation 
with Member States, the applicant  and EFSA on the pesticide risk assessment for ipconazole  in light of 
confirmatory data. EFSA  supporting publication 2017:EN -1260. ; doi:10.2903/sp.efsa.2017.EN -1260 . 
6 Committee for Risk Assessment , Opinion proposing harmonised classification and labelling at EU level 
of ipconazole (ISO); (1RS,2SR,5RS;1RS,2SR,5SR) -2-(4-chlorobenzyl) -5-isopropyl -1-(1H-1,2,4 -EN 2  EN No 1272/2008  of the European Parliament and of the Council7 in which it concluded , 
amongst others,  that ipconazole  meets the criteria to be classified as toxic for 
reproduction category  1B. 
(4) Commission Delegated Regulation (EU) 2020/11828 consequently amended Annex VI 
to Regulation (EC) No 1272/2008 and classified ipconazole  as toxic for reproduction 
category  1B. 
(5) In accordance with Article 4(3), point (e)(ii), of  Regulation (EC) No 1107/2009, an 
active substance can only be approved if a plant protection product containing it does 
not have unacceptable effects on the environment, in particular on non -target species, 
which includes birds.  
(6) Under p oint 3.6.4 of Anne x II to Regulation (EC) No 1107/2009  an active substance is 
only to be approved  if it is not or has not to be classified in accordance with the 
provisions of  Regulation (EC) No 1272/2008  as toxic for reproduction category  1B, 
unless the exposure of humans to that substance  in a plant protection product under 
realistic proposed conditions of use  is negligible.   
(7) In accordance with Article 21(1) of Regulation (EC) No 1107/2009 , the Commission 
informed the Member States , the Authority  and the applicant that it  considered the 
approval criteri a laid down in Article 4 (3), point (e)(ii) , of that Regulation and in point 
3.6.4 of  Annex II to that Regulation  may no longer be met  given that a high long -term 
risk to birds was identified and ipconazole  is classified as toxic for reproduction 
category 1B . The Commission invited the applicant to submit comments . 
(8) The applicant provided comments and additional information which were considered 
and assessed  by the  new rapporteur Member State, Belgium.  
(9) The Comm ission requested the Authority to consider the information provided by the 
applicant, taking into consideration the assessment by the  new rapporteur Member 
State , and specifically to consider the risks posed to birds from representative uses of 
ipconazole and whether the requirements regarding negligible exposure for humans 
(dietary and non -dietary exposure) set out in point 3.6.4 of Annex II to Regulation 
(EC) No  1107/2009 may be considered satisfied.   
(10) On 1 February 2022, the Authority communicated to the  Commission its statement9 in 
which it indicated  that although residues of ipconazole in food are below the default 
value of 0 ,01 mg/kg and hence dietary exposure to ipconazole is expected to be 
negligible, there are uncertainties about  exposure to operato rs and workers due to 
limitations in the studies submitted . In particular, for operators, measurements of 
exposure during equipment cleaning were not included in the study and the exposure 
                                                                                                                                                         
triazol -1-ylmethyl)cyclopentanol [CAS No. 125225 -28-7 (all stereoisomers); CAS No. 115850 -69-6 
(cis-cis racemate); CAS No. 115937 -89-8 (cis -trans racemate)] EC Number: - CAS Number: - CLH -O-
0000001412 -86-198/F . 
7 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006  (OJ L 353, 31.12.2008, 
p. 1). 
8 Commission Delegated Regulation (EU) 202 0/1182 of 19 May 2020  amending, for the purposes of its 
adaptation to technical and scientific  progress , Part 3 of Annex VI  to Regulation (EC) No  1272/2008 of 
the European Parliament and of the Council on classification, labelling and packaging of substances and 
mixtures (OJ L 261, 11.8.2020, p.  2).  
9 EFSA Panel (European Food Safety Authority), 2 022. Statement concerning the  review of the approval 
of the active substance ipconazole. EFSA Journal 2022;20(8):7133,  
https://doi.org/10.2903/j.efsa.2022.7133 . EN 3  EN during bagging was minimised due to a highly automated process , therefore limiting 
the representativeness of the study when considering the commonly used seed 
treatment practices across the Union . Thus, the study was of limited  use.  Furthermore, 
concerning workers, the study provided was of limited value since it only included 
data for two workers. Moreover, f or one  of th ose workers,  exposure could not  be 
considered negligible, even taking into account the use of personal protective 
equipment .  
(11) In addition, the Authority concluded that there is a high long -term risk to birds from 
the representative uses of ipconazole even after taking into account all appropriate 
refinements in the risk assessment.  
(12) The Commission invited the applicant to submit its  comments on the statement of the 
Authority and on its proposal to withdraw the approval of ipconazole due to the 
concerns identified by the Authority. The applicant submitted its comments, which 
have been carefully examined.  
(13) The Commission considers that  ipconazole no longer fulfils the criteria for approval 
laid down in Article 4(3) , point (e)(ii) , of Regulation (EC) No 1107/2009 and in point 
3.6.4 of Annex II to that Regulation . 
(14) It is therefore appropriate to withdraw the approval of ipconazole .  
(15) Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly  
and Implement ing Regulation (EU) No 571/2014  should be repealed . 
(16) Member States should be provided with  sufficient  time to withdraw authorisations for 
plant protection products  containing ipconazole . 
(17) For plant protection products containing ipconazole , where Member States grant any 
grace period in accordance with Article  46 of Regulation (EC) No  1107/2009, that 
period should  be as short as possible  and expire no later than  6 months from the date 
of entry into force  of this Regulation . 
(18) This Regulation does not prevent the submission of a new application for the approval 
of ipconazole  pursuant to Article  7 of Regulation (EC) No  1107/2009.  
(19) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Withdrawal of approval  
The a pproval of the active substance  ipconazole  is withdrawn.  
Article 2 
Amendment to Implementing Regulation (EU) No 540/2011  
In Part B  of the Annex to Implementing Regulation (EU) No 540/2011, row 73 on ipconazole  
is deleted.  EN 4  EN Article 3 
Transitional measures   
Member States shall withdraw authorisations fo r plant protection products containing 
ipconazole  as active substance by … [Office of Publications : please insert date 3 months after 
entry into force  of this Regulation ]. 
Article 4  
Grace period  
Any grace period granted by Member States in accordance with Article 46 of Regulatio n (EC) 
No 1107/2009 shall expire by … [Office of Publications : please  insert date 6 months from the 
date of entry into force  of this Regulation ].  
Article 5 
Repeal  
Implementing Regulation (EU) No 571/2014 is repealed.  
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 applicable in all Member 
States.  
Done at Brussels,  
 For the Commission  
 The President  
Ursula VON DER LEYEN