 
EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11708/2018  
[…](2019) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the approval of the active substance methiocarb, 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)    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the approval of the active substance methiocarb, 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,  
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  79/11 7/EEC and 91/414/EEC1, and in particular 
Article  20(1)   and Article 78(2) thereof,  
Whereas:  
(1) Commission Directive 2007/5/EC2 included methiocarb  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 1 107/2009 and are listed in Part  A of the 
Annex to Commission Implementing Regulation (EU) No  540/20114. 
(3) The approval of the active substance methiocarb , as set out in Part A of the Annex to 
Implementing Regulation (EU) No 540/2011 , expires on 31  July 2020. 
(4) An application for the renewal of the approval of methiocarb  was submitted in 
accordance with Article 1 of Commission Implementing Regulation (EU) 
No 844/20125 within the time period provided for in that Article.  
(5) The applicant 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.  11). 
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 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 of the renewal procedure for active subst ances, 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 2  EN (6) The rapporteur Member State prepared a  renewal assessment report in consultation 
with the co -rapporteur Member State and submitted it to the European Foo d Safety 
Authority ( ‘the Aut hority’) and the Commission on 13 July 2017 . 
(7) The Authority communicated the renewal assessment report to the applicant  and to the 
Member States for comments and forwarded the comments received to the 
Commission. The Authority also made the supplementary summary dossier  available 
to the public.  
(8) On 24 September 2018  the Authority communicated  to the Commission its 
conclusion6  on whether methiocarb  can be expected to meet the approval criteria  
provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented 
the draft renewal report for methiocarb  to the Standing Committee on Plant s, Animals, 
Food and Feed  on 24 January  2019 . 
(9) The Authority identified  an unacceptable risk to workers , even when taking into account 
the u se of personal protect ive equipment and a high risk to birds, mammals and 
earthworms . Furthermore, the Authority could not conduct the consumer risk 
assessment because the residue definition for risk assessment in plant commodities 
could  not been finalised since the genotoxic potential of metabolite  M01 could not be 
ruled out based on the available data.  
(10) The Commission invited the applicant to submit its comments on the conclusion of the 
Authority. Furthermore, in accordance with the third subparagraph of Article 14(1) of 
Imple menting Regulation (EU) No 844/2012, the Commission invited the applicant to 
submit comments on the draft renewal report. The applicant submitted its comments, 
which have been carefully examined.  
(11) However, despite the arguments put forward by the applicant,  the concerns regarding 
the active substance  could not be eliminated.  
(12) 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 provided 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 methiocarb  in accordance with 
Article  20(1)(b) of that Regulation . 
(13) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly.  
(14) Member States should be provided with  sufficient  time to withdraw authorisations for 
plant  protection products containing methiocarb.  Taking into account the risk 
identified for workers  from seed treatment and for birds, wild mammals, earthworms 
from treated seeds, for plant protection products containing  methiocarb , where 
Member States grant any grace period in accordance with Article  46 of Regulation 
(EC) No 1107/2009, t hat period should  at the latest,  expire on [Office of Publication s 
please insert date 6 months from the date of entry into force].   
(15) Commission Implementing Regulation (EU) XXX7 extended the approval period  of 
methiocarb  to 31 July 2020  in order to allow the renewal process to be completed 
                                                 
6  EFSA (Europ ean Food Safety Authority), 2018 . Conclusion on the peer review of the pesticide risk 
assessment of the active substance methiocarb EFSA Journal 2018;16(10):5429 . 
7 Commisison Implementing Regulation (EU) XXX of XXX amending Implementing Regulation (EU) 
No 540/2011 as regards the extension of the app roval periods  of the active substances 
  
EN 3  EN before the expiry of the approval of that substance. However, g iven that a decision on 
the non -renewal of the approval is taken ahead of that extended expiry date, this 
Regulation should apply as soon as possible.  
(16) This Regulation does not prejudice the sub mission of a further application for the 
approval of methiocarb  in accordance with  Article 7 of Regulation (EC) 
No 1107/2009.  
(17) 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  
Non-renewal of the approval of the active substance  
The approval of the active substance methiocarb  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 148, on 
methiocarb , is deleted.  
Article 3 
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
methiocarb  as active substance by [ Office of Publications pl ease insert date 3 months  from the 
date of entry into force ] at the latest.  
Article 4 
Grace period  
Any grace period granted by Member States  in accordance with Article 46 of Regulation (EC) 
No 1107/ 2009 shall be as short as possible and shall expire by [Office of Publications please 
insert date 6 months from the date of entry into force ], at the latest.  
Article 5 
Entry into force  and application  
This Regulation shall enter into force on the third day following that of its publication in the 
Official Journal of the European Union .  
 
                                                                                                                                                         
alpha -cypermethrin, beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, 
cyazofamid, desmedipham, dimethoate, dimethomorph, diuron, ethephon, etoxazole, famoxadone, 
fenamiphos, flumioxaz ine, fluoxastrobin, folpet, foramsulfuron, formetanate, metalaxyl -m, methiocarb, 
metribuzin, milbemectin, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos -
methyl, propamocarb, prothioconazole, s -metolachlor and tebuconazole  (OJ L XXX , XX, p. XX).  
EN 4  EN This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER  
 