EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12268/2020  
[…](2022) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
renewing the approval of the active substance captan 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 Imple menting 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 captan 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  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Havi ng 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/EEC1, and in particular 
Article  20(1)  thereof , 
Whereas:  
(1) Commission Directive  2007/5/EC2 included captan  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 captan , as set out in Part A of the Annex to 
Implementing Regulation (EU) No 540/2011 , expires on 31 July 2023. 
(4) An application for the  renewal of the approval of the active substance  captan  was 
submitted to the rapporteur Member State and 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.  
(5) The applicant s submitted the supplementary dossiers required in accordance with 
Article  6 of Implementing  Regulation (EU) No 844/2012. The application was found 
to be complete by the rapporteur Member State.  
                                                 
1 OJ L  309, 24.11.2009, p. 1.  
2 Commission Directive 2007/5/EC of 7 February 2007 amending Council Directive 91/414/EEC to 
include captan, folpet, formetanate and methiocarb as active substances (OJ L 35, 8.2.2007, p. 14).  
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). 
4 Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation 
(EC) No 1107/2009 of th e 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 o f 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 of plant protection products on the market  (OJ L 252, 19.9.2012, p.  26). EN 3  EN (6) The rapporteur Member State prepared a  draft renewal assessment report in 
consultation with the co -rapporteur Member State and submitted it to the European 
Food Safety Authority ( ‘the Aut hority’) and the Commission on 4 December  2017 . 
(7) The Authority communicated  the draft renewal assessment report to the applicant s and 
made it available to the public and  forwarded the  comments received to the 
Commissi on. The Authority made the supplementary summary dossier available to the 
public.  
(8) On 24 July 2020 , the Authority communicated  to the Commission its conclusion6 on 
whether captan  can be expected to meet the approval criteria provided for in Article  4 
of Regulation (EC) No  1107/2009.  The Authority  concluded that captan does not meet 
the criteria for identifying endocrine disrupting properties set in point 3.6.5 and point 
3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission 
Regulation  (EU) 2018/6057. 
(9) The Commission presented a renewal report and the draft Regulation regarding captan 
to the Standing Committee on Plants, Animals, Food and Feed on 24 March 2020 and 
13 October 2022 respectively and a revised version of the renewal report o n 14 July 
2022.  
(10) The Commission invited the applicant s 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 both versions of the renewal report. 
The applica nt submitted its comments  on both versions of the renewal report , which 
have been  carefully examined . 
(11) It has been established with respect to one or more representative uses of at least one 
plant protection product containing the active substanc e captan  that the approval 
criteria provided for in Article  4 of Regulation (EC) No  1107/2009 are satisfied.  
(12) The risk assessment for the renewal of the approval of the active substance captan  is 
based on representative uses as  fungicide . While it is not necessary, in the light of this 
risk assessment, to maintain the restriction to use only as a fungicide , it is necessary to 
provide, in accordance with Arti cle 14(1) of Regulation (EC) No  1107/2009 in 
conjunction with Article 6 thereof an d in the light of current scientific and technical 
knowledge, for certain conditions and restrictions. It is, in particular, appropriate to 
restrict the use of plant protection products containing captan  to use in greenhouses  
with the obligation that they remain closed from the time of application until harvest  to 
mitigate the risk to wild mammals, fish, aquatic inverteb rates , bees and non -target 
arthropods other than bees  and to require further confirmatory information  as regards 
the effect of water treatment processes  on the nature of residues present in drinking 
water . 
(13) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly . 
(14) Commission Implementing Regulation (EU) 2022/7088 extended the approval period  
of captan  to 31 July 2023 in order to allow the renewal process to be completed before 
                                                 
6 EFSA Journal 2020 ;18(9):6230  (revised  on 11 November  2020) . Available online: www.efsa.europa.eu . 
7 Commission 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). 
8  Commission Implementing Regulation (EU) 2022/708  of 5 May 2022 amending Implementing 
Regulation (EU) No 540/2011 as regards the extension of the approval per iods of the active substances EN 4  EN the expiry of the approval period of that active substance. However, g iven that a 
decision on renewal has been  taken ahead of that extended expiry date , this Regulation 
should apply earlier than that date . [ 
(15) 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  
Renewal of the approval of the active substance  
The approv al of the active substance  captan , 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  
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 March 202 3. 
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  
                                                                                                                                                         
2,5-dichlorobenzoic acid methylester, acetic acid, aclonifen, aluminium ammonium sulphate, 
aluminium phosphide, aluminium silicate, beflubutamid, benthiavalicarb, boscalid, calcium carbide, 
captan, cymoxanil, dimethomorph, dod emorph, ethephon, ethylene, extract from tea tree, fat distilation 
residues, fatty acids C7 to C20, fluoxastrobin, flurochloridone, folpet, formetanate, gibberellic acid, 
gibberellins, hydrolysed proteins, iron sulphate, magnesium phosphide, metam, metamit ron, 
metazachlor, metribuzin, milbemectin, phenmedipham, pirimiphos -methyl, plant oils/clove oil, plant 
oils/rape seed oil, plant oils/spear mint oil, propamocarb, proquinazid, prothioconazole, pyrethrins, 
quartz sand, fish oil, repellents by smell of anim al or plant origin/sheep fat, S -metolachlor, Straight 
Chain Lepidopteran Pheromones, sulcotrione, tebuconazole and urea  (OJ L 133, 10.5.2022, p. 1 ).