EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/2347  
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the approval of the active substance dimethomorph, 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 dimethomorph, 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  79/117/EEC and 91/414/EEC 1, and in particular 
Article  20(1) and Article  78(2) thereof,  
Whereas:  
(1) Commission Directive  2007/25/EC2 included dimethomorph  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 d eemed 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 dimethomorph , as set out in Part A of the Annex 
to Implement ing Regulation (EU) No 540/2011, expires on 15 February  2025.  
(4) An application for the renewal of the approval of the active substance dimethomorph  
was submitted to the Netherlands , the rapporteur Member State, and Germany , the co -
rapporteur Member State, i n accordance with Article  1 of Commission Implementing 
Regulation (EU) No 844/20125 within the time period provided for in that Article.  
 
1 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/EEC  (OJ L 309, 24.11.2009, p. 1 ,  
ELI: http://data.europa.eu/eli/reg/2009/1107/oj ). 
2 Commission Directive 200 7/25/EC of 2 4 April 200 7 amending Council Directive 91/414/EEC to 
include dimethomorph  as active substance  (OJ L 106, 24.4.2007, p. 34 ,  
ELI: http://data.europa.eu/eli/dir/2007/25/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 Commiss ion 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 activ e 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 , ELI: 
http://data.europa.eu/eli/reg_impl/2012/844/oj ).  
EN 2  EN (5) The applicant s 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 complete by the 
rapporteur Member State.  
(6) The rapporteur Member State pr epared a draft renewal assessment report in 
consultation with the co -rapporteur Member State and submitted it to the Authority 
and the Commission on 1 August 2017 . In its draft renewal assessment report the 
rapport eur Member State proposed to renew the approval of dimethomorph . 
(7) The Authority made the supplementary summary dossier available to the public. The 
Authority also circulated the draft renewal assessment report to the applicants and to 
the Member States for co mments and launched a public consultation on it. The 
Authority forwarded the comments received to the Commission.  
(8) On 26 May 2023 , the Authority communicated to the Commission its conclusion6 on 
whether dimethomorph  can be expected to meet the approval cri teria provided for in 
Article  4 of Regulation (EC) No  1107/2009.  
(9) In its conclusion, t he Authority identified several  areas of concern. In particular, 
dimethomoph has been  classified as toxic to reproduction, category 1B. On 
20 September  2019 , the Committee for Risk Assessment of the European Chemicals 
Agency adopted an opinion7 in accordance with Article 37(4) of Regulation (EC) 
No 1272/2008 of the European Parliament and of the Coun cil8 in which it concluded 
that dimethomorph has been classified as toxic to reproduction, category 1B (H360F 
‘may damage fertility’). Commission Delegated Regulation (EU) 2021/8499 
consequently amended Annex VI to Regulation (EC) No 1272/2008 and classified 
dimethomorph as toxic for reproduction category  1B. 
(10) The Authority  also concluded that dimethomorph meets the criteria for endocrine 
disruptors for humans and wild mammals as non -target organisms set out in  
points  3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 , due to its 
oestrogen, androgen and steroidogenesis (EAS) -modalities .  
(11) Negligible exposure cannot be demonstrated for dimethomorph since residues above 
the defau lt value of 0.01 mg/kg are expected to occur for all representative uses and in 
rotational crops. Therefore, the requirements set out in point s 3.6.4  and 3.6.5 of 
Annex  II to Regulation (EC) No 1107/2009 are not fulfilled.  
(12) The Authority concluded that dime thomorph  is not necessary to control a serious 
danger to plant health which cannot be contained by other available means including 
 
6 Conclusion on the peer review of the pesticide risk assessment of the active substance dimethomorph  
EFSA Journal  2023;21(6):8032 . 
7 European Chemicals Agency (2019). Opinion of the Committee for Risk Assessment proposing harmonised 
classification and labelling of dimethomorph (ISO); (E,Z) -4-(3-(4-chlorophenyl) -3-(3,4-
dimethoxyphenyl)acryloyl)morpholine (EC Number: 404-200-2; CAS Number : 110488 -70-5) 
(https://echa.europa.eu/documents/10162/8c2bdfa6 -bd1f-15d2 -8c76 -fd8c0d38695b ). 
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/oj ). 
9 Commission Delegated Regulation (EU) 2021/849 of 11  March 2021 amending, for the purposes of its 
adaptation to technical and scientific progress, Part 3 of Annex VI t o Regulation (EC) No  1272/2008 of 
the European Parliament and of the Council on classification, labelling and packaging of substances and 
mixtures  (OJ L 188, 28.5.2021, p. 27 , ELI: http://data.europa.eu/eli/reg_del/2021/849/oj ).  
EN 3  EN non-chemical methods , in accordance with Art icle 4(7) of Regulation (EC) 
No 1107/2009 . For the representative uses of the ren ewal of the active substance 
(Phytophthora  disease in strawberries, downy mildew in lettuce and grapevine), 
alternative active substances are available in most cases and a derogation may be 
scientifically justified  only in very few cases , e.g. in cases of non-availability and/or 
non-feasibility of alternative non -fungicide methods. Furthermore a  combination of 
chemical and non -chemical methods may be possible to control the pests in some 
crops. In addition, no serious danger to plant health has been identif ied which would 
require the use of dimethomorph . 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 fulfilled.  
(13) The Commission presented a  draft renewal report for dimethomorph  to the Standing 
Committee on Plants, Animals, Food and Feed on 12  October  2023.  
(14) The Commission invited the applicant s to submit its comments on the conclusion of 
the Authority. Furthermore, in accordance with Article 1 4(1), third subparagraph, of 
Implementing Regulation (EU) No 844/2012, the Commission invited the applicant s 
to submit comments on the renewal report. The applicant submitted its comments, 
which have been carefully examined.  
(15) Despite the arguments put forwa rd 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 protection product that the approval criteria provide d 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 dimethomorph  in accordance with 
Article  20(1), point (b), of that Regulation . 
(17) Implementing Regulation (EU) No 54 0/2011 should therefore be amended 
accordingly.  
(18) Member States should be given sufficient time to withdraw authorisations for plant 
protection products containing dimethomorph . 
(19) For plant protection products containing dimethomorph , where Member States grant  
any 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) 2023/91810 extended the period of 
approva l of dimethomorph until 15 February 2025  in order to allow the renewal 
process to be completed before the expiry of the approval period of that substance. 
However, given that a decision on the non -renewal of the approval is taken ahead of 
 
10 Commission Implementing Regulation (EU) 2023/918 of 4  May 2023 amending Implementing 
Regulation (EU) No  540/2011 as regards the extension of the approval periods of the active substances 
aclonifen, ametoctradin, beflubutamid, benthiavalicarb, boscalid, captan, clethodim, cycloxydim, 
cyflumetofen, dazomet, diclofop, dimethomorph, ethephon, fenazaquin, fluopicolide, fluoxastrobin, 
flurochloridone, folpet, for metanate, Helicoverpa armigera nucleopolyhedrovirus, hymexazol, 
indolylbutyric acid, mandipropamid, metalaxyl, metaldehyde, metam, metazachlor, metribuzin, 
milbemectin, paclobutrazol, penoxsulam, phenmedipham, pirimiphos -methyl, propamocarb, proquinazid, 
prothioconazole, S -metolachlor, Spodoptera littoralis nucleopolyhedrovirus, Trichoderma asperellum 
strain T34 and Trichoderma atroviride strain I -1237  (OJ L 119, 5.5.2023, p. 160 , ELI: 
http://da ta.europa.eu/eli/reg_impl/2023/918/oj ).  
EN 4  EN the expiry of tha t extended approval period, this Regulation should apply earlier than 
that date.  
(21) This Regulation does not prevent the submission of a further application for the 
approval of dimethomorph  pursuant to Article  7 of Regulation (EC) No  1107/2009.  
(22) The measures p rovided 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  
Non-renewal of approval of active substance  
The approval of the active substance dimethomorph  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 150  on 
dimethomorph  is deleted.  
Article 3  
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
dimethomorph  as an active substance by … [ Office of Publications please insert date 
6 months from the date of entry into force of this 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 Regulation] . 
Article 5  
Entry into force  
This Regulation shall enter into force on 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