EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/1253  
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the approval of the active substance metiram, 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 metiram, 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 o f 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) and Article 78(2) thereof,  
Whereas:  
(1) Commission Directive 2005/72/EC2 included metiram  as an active substance in Annex 
I to Council Directive 91/414/EEC3. 
(2) According to Article 78(3) of Regulation (EC) No 1107/2009, a ctive 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 metiram , as set out in Part A of the Annex to 
Implementing Regulation (EU) No 540/2011 , expires on 31 January  2024 . 
(4) Applications for the renewal of the approval of metiram  were submitted  to Italy, the 
rapporteur Member State , and to the Un ited Kingdom , the co-rapporteur Member 
State,  in accordance with Article 1 of Commission Implementing Regulation (EU) 
No 844/20125 within the time period provided for in that Article.  
                                                 
1 OJ L 309, 24.11.2009, p.  1. 
2 Commission Directive 2005/72/EC of 21 October 2005 amending Council Directive 91/414/EEC to 
include chlorpyrifos, chlorpyrifos -methyl, mancozeb, maneb, and metiram as active substances  
(OJ L 279, 22.10.2005, p. 63 ). 
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 the European Parliament and of the Council as regards the list of approved act ive 
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 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), which continues to 
apply to the procedure 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 substances, as provided for in  
  
EN 2  EN (5) The applicants submitted the supplementary dossiers required to the rapp orteur 
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 applications were 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 2 November  2017 .  
(7) The Authority communicated  the draft renewal assessment report to the applicants and 
to the Member States for comments and launched a public consultation on it. The 
Authority forwarded the comments received to the Commission.  The Authority made 
the supplementary summary dossier available to t he public.  
(8) On 20 March 2023, the Authority communicated to the Commission its conclusion6 on 
whether metiram can be expected to meet the approval c riteria provided for in 
Article  4 of Regulation (EC) No  1107/2009. The Authority identified several critical 
areas of concern. In particular, it concluded that the reference values of metiram and 
its relevant fungicidally active metabolites for operator, bystander and resident 
exposures are exceeded in all representative uses. In addition, the Authority identifie d 
a high risk to aquatic organisms and high in -field risk for non -target arthropods for all 
representative uses. The Authority also concluded that metiram meets the criteria to be 
identified as endocrine disruptor for humans for the T  modality.  
(9) In accordan ce 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 .  
(10) The Commission presented a draft renewal report regarding metiram and a draft of this 
Regulation to the Standing Committee on Plants, Animals, Food and Feed on 
24 May 2023 . 
(11) The Commission invited the applicants to submit their comments on the conclusion s 
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 draft renewal report. The applicants submitted their 
comments , which have been carefully examined.  
(12) Despite the arguments put forward by the applicants , the concerns regarding the active 
substance metiram could not be eliminated.  
(13) Consequently, it has no t been established with respect to one or more representative 
uses of at least one plant protection product containing metiram  that the approval 
criteria provided for in Article  4 of Regulation (EC) No  1107/2009 are satisfied. It is 
therefore appropriate n ot to renew the approval of th at active substance.  
(14) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly.  
                                                                                                                                                         
               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 Peer review of the pesticide risk assessment of the active substan ce metiram . EFSA Journal  
2023;21(4):7937 .  
EN 3  EN (15) Member States should be given sufficient time to withdraw authorisations for plant 
protection products containing metiram . 
(16) For plant protection products containing metiram , 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.  
(17) Commiss ion Implementing Regulation (EU)  2023/1147 extended the approval period 
of metiram  to 31 January  2024 in order to allow the renewal process to be completed 
before the expiry of the approval period of that substance. However, g iven that a 
decision on the non -renewal of the approval has been taken ahead of the expiry of that 
extended approval period , this Regulation should start to apply earlier than that date . 
(18) This Regulation does not prevent the submission of a further applicat ion for the 
approval of metiram  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  
Non-renewal of the approval of the active substance  
The approval of the active substance metiram  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 115 on metiram , 
is deleted.  
Article 3  
Transitional measures  
Member States shall withdraw authorisations for plant p rotection products containing metiram  
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 fr om 
the date of entry into force  of this implementing regulation ]. 
                                                 
7 Commission Implementing Regulation (EU) 2023/114 of 16  January 2023 amending Implementing 
Regulation (EU) No  540/2011 as regards the extension of the approval periods of the active substances 
benzovindiflupyr, bu profezin, cyflufenamid, fluazinam, flutolanil, lambda -cyhalothrin, mecoprop -P, 
mepiquat, metiram, metsulfuron -methyl, phosphane and pyraclostrobin  (OJ L 15, 17.1.2023 , p 9).  
EN 4  EN 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 b inding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN