COMMI SSION IMPLEMENTING REGUL ATION (EU) 2019/1606 
of 27 September 2019 
concer ning the non-renewal of the appro val of the activ e subst ance methiocarb, in accordance 
with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concer ning 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 EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regar d to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 
concer ning the placing of plant prote ction products on the mark et 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 2007/5/EC (2) included methiocarb as an active substance in Annex I to Council Directive 
91/414/EEC (3). 
(2)  Active substances included in Annex I to Directive 91/414/EEC are deemed to have been appro ved under 
Regulation (EC) No 1107/2009 and are liste d in Part A of the Annex to Commission Implementing Regulation 
(EU) No 540/2011 (4). 
(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 844/2012 (5) within the time period provided for in that Article. 
(5)  The applicant submitted the supplementar y dossiers required in accordance with Article 6 of Imple menting 
Regulation (EU) No 844/2012. The application was found to be complet e by the rappor teur Member State. 
(6)  The rappor teur Member State prepared a renewal assessment repor t in consultation with the co-rappor teur 
Member State and submitt ed it to the European Food Safet y Author ity (‘the Author ity’) and the Commission on 
13 July 2017. 
(7)  The Author ity communicate d the renewal assessment repor t to the applicant and to the Member States for 
comments and forwarded the comments received to the Commission. The Authority also made the supple ­
mentar y summar y dossier available to the public. 
(8)  On 24 Sept ember 2018 the Author ity communicat ed to the Commission its conclusion (6) on whether 
methiocarb can be expecte d to meet the appro val criteria provided for in Article 4 of Regulation (EC) 
No 1107/2009. The Commission present ed the draf t renewal repor t for methiocarb to the Standing Committ ee 
on Plants, Animals, Food and Feed on 24 Januar y 2019. 30.9.2019 L 250/53 Official Jour nal of the European Union EN     
(1)OJ L 309, 24.11.2009, p. 1. 
(2)Commission Directive 2007/5/EC of 7 Febr uary 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 concer ning 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 regar ds the list of approved active substances (OJ L 153, 11.6.2011, p. 1). 
(5)Commission Implementing Regulation (EU) No 844/2012 of 18 Sept ember 2012 setting out the provisions necessar y for the implemen ­
tation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and 
of the Council concer ning the placing of plant prot ection products on the market (OJ L 252, 19.9.2012, p. 26). 
(6)EFSA (European Food Safet y Authority), 2018. Conclusion on the peer review of the pesticide risk assessment of the active substance 
methiocarb EFSA Jour nal 2018;16(10):5429. (9)  The Authority identified an unaccept able risk to workers, even when taking into account the use of personal 
prot ective equipment and a high risk to birds, mammals and earthwor ms. Further more, the Author ity could not 
conduct the consumer risk assessment because the residue definition for risk assessment in plant commodities 
could not been finalised since the genot oxic poten tial of metabolite M01 could not be ruled out based on the 
available data. 
(10)  The Commission invit ed the applicant to submit its comments on the conclusion of the Author ity. Further more, 
in accordance with the third subparagraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, the 
Commission invit ed the applicant to submit comments on the draf t renewal repor t. The applicant submitte d its 
comments, whic h have been carefully examined. 
(11)  Howe ver, despit e the arguments put forward by the applicant, the concer ns 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 
prot ection product that the approval criteria provi ded for in Article 4 of Regulation (EC) No 1107/2009 are 
satisfied. It is theref ore appropr iate 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 theref ore be amended according ly. 
(14)  Member States should be provided with suffi cient time to withdraw author isations for plant prote ction products 
containing methiocarb. Taking into account the risk identified for workers from loading and sowing the treated 
seeds 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, that period should at the lates t, expire on 3 Apr il 2020. 
(15)  Commission Implementing Regulation (EU) 2019/707 (7) extended the appro val period of methiocarb to 31 July 
2020 in order to allow the renewal process to be compl eted before the expir y of the approval of that substance. 
Howe ver, given that a decision on the non-renewal of the approval is taken ahead of that exte nded expir y date , 
this Regulation should apply as soon as possible. 
(16)  This Regulation does not prejudice the submission of a further application for the approval of methiocarb in 
accordance with Article 7 of Regulation (EC) No 1107/2009. 
(17)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
Non-renewal of the appro val of the activ e subst ance 
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 delet ed. 30.9.2019 L 250/54 Official Jour nal of the European Union EN     
(7)Commission Implementin g Regulation (EU) 2019/707 of 7 May 2019 amending Implementing Regulation (EU) No 540/2011 as 
regar ds the exten sion of the approval periods of the active substances alpha-cyper methr in, beflubutamid, benalaxyl, benthia valicarb, 
bifenazate, boscalid, bromo xynil, captan, cyazofam id, desmedipham, dimethoate, dimethomor ph, diuron, ethephon, etoxazole, 
famo xadone, fenamiphos, flumio xazine, fluoxastrobin, folpet, foramsulfuron, formetanate, metalaxyl-m, methiocarb, metr ibuzin, 
milbemectin, Paecilom yces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl , propamocarb, prothioconazole, s- 
metolachlor and tebuconazole (OJ L 120, 8.5.2019, p. 16). Article 3 
Transitional measures 
Member States shall withdra w author isations for plant protection products containing methiocarb as active substance by 
3 Januar y 2020 at the latest. 
Article 4 
Grace period 
Any grace period grant ed by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as 
shor t as possible and shall expire by 3 Apr il 2020, at the latest. 
Article 5 
Entr y into force and application 
This Regulation shall enter into force on the third day followi ng 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 State s. 
Done at Brussels, 27 September 2019. 
For the Commission 
The President 
Jean-Claude JUNCK ER  30.9.2019 L 250/55 Official Jour nal of the European Union EN