EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/2697  
[…](2024) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
renewing the approval of the active substance metconazole as a candidate for 
substitution 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 2  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
renewing the approval of the active substance metconazole as a candidate for 
substitution 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 t he 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/EEC1, and in particular 
Article  20(1) in conjunction with Article 24 (1) thereof , 
Whereas:  
(1) Commission Directive 2006/74 /EC2 included metconazole  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 metconazole , as set out in Part A of the Annex to 
Implementing Regulation (EU) No 540/2011 , expires on 15 March  2025 . 
(4) An application for the renewal of the approval of the active substance metconazole  
was submitted to Belgium , the rapporteur Member State,  and the United Kingdom , the 
co-rapporteur Member State,  in accordance with Article 1 of Commission 
Implementing Regulation (E U) No 844/20125 and within the time period provided for 
in that Article.   
                                                 
1 OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj.   
2 Commission Directive  2006/74/EC of 21 August 2006 amending Council Directive 91/414/EEC to 
include dichlorprop -P, metconazole, pyrimethanil and triclopyr as active substances (OJ L 235, 
30.8.2006, p. 17, ELI: http://data.europa.eu/eli/dir/2006/74/oj).  
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,  ELI: http://data.europa.eu/eli/dir/1991/414/oj).  
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,  ELI: http://data.europa.eu/eli/reg_impl/2011/540/oj).  
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 substan ces, 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, ELI: 
http://data.europa.eu/eli/reg_impl/2012/844/oj ).  
EN 3  EN (5) The applicant submitted the supplementary dossiers requi red 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 rapporteu r 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 26 February  2018 . In its draft renewal asses sment report the 
rapport eur Member State  proposed to renew the approval of metconazole .  
(7) The Authority made the supplementary 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) On 12 July 2019 , the Authority requested additional information from the applicant on 
the endocrine disrupti ng proper ties of metconazole  pursuant to Article 13(3 a), first 
subparagraph,  of Implementing Regulation (EU) No 844/2012. The applicant 
submitted information to allow the Authority to conclude the assessment as regards 
whether the scientific criteria  for the determ ination of endocrine disrupting properties  
set out in point  3.8.2 of Annex II to Regulation (EC) No 1107/2009, as introduced by 
Commission Regulation (EU)  2018/6056, are met .  
(9) In April 2022 , the rapporteur Member State made an updated draft renewal asse ssment 
report available to the Authority, the Member States and the Commission. In its 
updated draft renewal assessment report, the rapporteur Member State considered the 
additional information regarding the criteria to identify endocrine disrupting propert ies 
and proposed renewing the approval of metconazole . 
(10) On 11 July 2023 , the Authority communicated  to the Commission its conclusion7 
which indicated  metconazole  can be expected to meet the approval criteria provided 
for in Article  4 of Regulation (EC) No  1107/2009.  
(11) The Commission presented a renewal report and a draft of this Regulation to the 
Standing Committee on Plant s, Animals, Food and Feed  on 11 and 12  December  2023 
and on 30 and 31 January  2024  respectively . 
(12) The Commission invited the applicant to submit its comments on the conclusion of the 
Authority and, in accordance with Article 14(1) , third subparagraph,  of Implementing 
Regulation (EU) No 844/2012, on the renewal report. The applicant submitted its 
comments, which have been  carefully examined  and taken into consideration . 
(13) It has been established with respect to one or more representative uses of at least one 
plant protection product containing the active substance metconazole  that the approval 
criteria provided for in Article  4 of Regulation (EC ) No 1107/2009 are satisfied.  
(14) The risk assessment for the renewal of the approval of the active substance 
metconazole  is based on a limited number of representative uses, which however do 
not restrict the uses for which plant protection products containing metconazole  may 
                                                 
6 Commis sion Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) 
No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties  
(OJ L 101, 20.4.2018, p. 33, ELI: http://data.europa.eu/eli/reg/201 8/605/2018 -04-20). 
7 EFSA Journal 2023, doi: 10.2903/j.efsa.2023.8141 . Available online: www.efsa.europa.eu .  
EN 4  EN be authorised. It is therefore appropriate not to maintain the restriction to use as a 
fungicide and plant growth regulator.   
(15) The Commission, however, considers that metco nazole is a candidate for substitution 
pursuant to Article 24 of Regulation (EC) No 1107/2009. Metconazole is considered a 
persistent and toxic substance in accordance with points  3.7.2.1 and 3.7.2.3 
respectively, of Annex II to Regulation (EC) No  1107/200 9, given that the half -life of 
metconazole  is higher than 40  days in fresh water and higher than 120  days in fresh 
water sediment ,  that the substance is  classified as toxic for reproduction (category 2) 
pursuant to Regulation (EC) No 1272/2008  of the Euro pean Parliament and of the 
Council8 and that the long-term no -observed effect concentration for freshwater 
organisms is less than 0.01  mg/L.  Therefore , it fulfils the condition set in the second 
indent of point  4 of Annex  II to Regulation (EC) No  1107/2009 . 
(16) It is therefore appropriate to renew the approval of metconazole  as a candidate for 
substitution  pursuant to Article 24 of Regulation (EC) No  1107/2009 .  
(17) In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction 
with Article  6 there of and in the light of current scientific and technical knowledge  
and the outcome of the risk assessment , it is, however, necessary to provide for certain 
conditions  and restrictions .  
(18) In the light of th e potential concern for an increasing prevalence of azole -resistant 
strains in A. fumigatus  and taking into account the precautionary principle, it is in 
particular appropriate to restrict the use of products containing metconazole to 
professional users onl y. 
(19) Furthermore, i t is appropriate to require further confirmatory information on the 
assessment of water treatment processes on residues of active substances or their 
metabolites in water abstracted for the production of drinking water  to be submitted 
once  the relevant guidance becomes applicable . In addition, to increase confidence in 
this decision, information should be  requested to confirm the appropriate toxicological 
reference values applicable to certain metabolites and the residue definition  for risk  
assessment.  
(20) Implementing Regulation (EU) No 540/2011 should be amended accordingly.  
(21) Commission Implementing Regulation (EU) 2015/4089 listed metconazole as a 
candidate for substitution. In the light of the renewal of approval of metconazole as a 
candidate  for substitution and the corresponding move of that substance to Part E of  
the Annex to Implementing Regulation (EU) No 540/2011, the entry for metconazole 
should be deleted from the Annex to Implementing Regulation (EU) 2015/408.   
 
                                                 
8  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, ELI: http://data.europa.eu/eli/reg/2008/1272/2023 -12-01). 
9  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 establis hing a list of candidates for substitution. 
(OJ L 67, 12.3.2015, p. 18, ELI: http://data.europa.eu/eli/reg_impl/2015/408/oj   
EN 5  EN (22) Commission Implementing Regulation (EU) 2023 /68910 extended the approval period  
of metconazole to 15 March 2025 in order to allow the renewal process to be 
completed before the expiry of the approval period of that active substance. However, 
given that a de cision on renewal has been taken ahead of that extended expiry date, 
this Regulation sh ould apply earlier than that date . 
(23) 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  
Renewal of the approval of the active substance  
The approval of the active substance  metconazole , as specified in Annex I to this Regulation,  
is renewed , subject to the conditions laid down in that Annex.  
Article 2  
Amendments to Implementing Regulation (EU) No 540/2011  
The Annex to Implementing Regulation (EU) No 540/2011 is  amended in accordance with 
Annex II to this Regulation.  
Article 3  
Amendment to Implementing Regulation (EU) 2015/408  
The entry for metconazole  is deleted from the Annex to Implementing Regulation (EU) 
2015/408.   
Article 4 
Entry into force and date of application  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
It shall apply from 1 September  2024.   
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
                                                 
10 Commission Implementing Regulation (EU) 2023/689 of 20  March 2023 amending Implementing 
Regulation (EU) No  540/2011 as regards the extension of the approval periods of the active substances 
Bacillus subtilis (Cohn 1872) strain  QST  713, Bacillus thuringiensis subsp. A izawai strains ABTS -1857 
and GC -91, Bacillus thuringiensis subsp. Israeliensis (serotype H -14) strain AM65 -52, 
Bacillus  thuringiensis subsp. Kurstaki strains ABTS 351, PB 54, SA 11, SA12 and EG  2348, Beauveria 
bassiana strains ATCC 74040 and GHA, clodinafo p, Cydia  pomonella Granulovirus (CpGV), 
cyprodinil, dichlorprop -P, fenpyroximate, fosetyl, malathion, mepanipyrim, metconazole, metrafenone, 
pirimicarb, pyridaben, pyrimethanil, rimsulfuron, spinosad, Trichoderma asperellum (formerly T. 
harzianum) strains  ICC012, T25 and TV1, Trichoderma atroviride (formerly T. harzianum) strain  T11, 
Trichoderma gamsii (formerly T. viride) strain ICC080, Trichoderma  harzianum strains T -22 and ITEM 
908, triclopyr, trinexapac, triticonazole and ziram (OJ L 91, 29.3.2023, p. 1, 
ELI: http://data.europa.eu/eli/reg_impl/2023/689/oj ).  
EN 6  EN Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN