EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/11493/2018 rev. 1  
[…](2018) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance dimethoate, 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 Ann ex 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 approval of the active substance dimethoate, 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 EUROPE AN 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 m arket 
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 2007/25/ EC2 included  dimethoate 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 dimethoate , as set out in Part A of the Annex to 
Implementing Regulation (EU ) No 540/2011, expires on 31  July 2019 . 
(4) An application for the renewal of the approval of dimethoate  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 2007/25/EC of 23 April 2007 amending Council Directive 91/414/EEC to 
include dimethoate, dimethomorph, glufosinate, metribuzin, phosmet and propamocarb as active 
substances  (OJ L 106, 24.4.2007, p. 34 ). 
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 substances, as provided 
for in Regulation (EC) No 1107/2009 o f 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 Food Safety 
Authority (  ‘the Authority’) and the Commission on 5 May 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 2 October  2018 the Authority communicated to the Commission its conclusion6 on 
whether dimethoate  can be expected to meet the approval criteria provided for in 
Article  4 of Regulation (EC) No  1107/2009.  The Commission presented to the 
Standing Committee on Plants, Animal, Food and Feed the draft renewal report for 
dimethoate  on 13 December 2018  and the draft regulation on 25 January 2019 . 
(9) The Authority identified s pecific concerns. In particular, it was not possible to exclude 
exposure risk to consumers, operators, workers, bystanders and residents due to their 
exposure to residues of dimethoate , for which the genotoxic potential could not be 
excluded , and its main metabolite omethoa te which was concluded to be an in vivo 
mutagenic agent by the majority of experts in the peer review .. Furthermore, the 
Authority concluded that  a high risk to mammals , and to non -target arthropods for 
dimethoate . and to honeybees for both dimethoate and omethoate was concluded for all 
the assessed representative uses . In addition, the Authority concluded that the technical 
specification, whether the current or the revised one, is not supported by the (eco) 
toxicological assessment   
(10) The Commission invited the applicant to submit  its comments on the conclusion of the 
Authority . Furthermore , in accordance with third subparagraph of Article  14(1)  of 
Implementing Regulation (E U) No 844/2012, the Commission invited the applicant to 
submit  comments on the draft renewal report. The applicant submitted their 
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. The approval of the active 
substance dimethoat e should therefore not be renewed.  
(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 dimethoate . 
(15) For p lant protection products containing  dimethoate , where Member States grant any 
grace period in accordance with Article  46 of Regulation (EC) No  1107/2009, th at 
period should, at the latest, expire on [Office of Publications please insert date 
12 months from  the date of entry into force] .  
                                                 
6 EFSA (European Food Safety Authority), 2018. Conclusion on the peer review of the pesticide risk 
assessment of th e active substance dimethoate  EFSA Journal 2018;16(1 0):5454. 
https://www.efsa.europa.eu/en/efsajournal/pub/5454 .  EN 3  EN (16) Commission Implementing Reg ulation (EU) 2018/ 9177 extended the approval period  
of dimethoate to 31  July 2019 in order  to allow the renewal process to be completed 
before the expiry of the approval period of that substance. Given that a decision on the 
non-renewal of the approval has been taken ahead of that extended expiry date, this 
Regulation should apply as soon as possible.  
(17) This Regulation does not p revent  the submission of a further application for the 
approval of dimet hoate  pursuant to Article 7 of Regulation (EC) No  1107/2009.  
(18) 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 approval of active substance  
The approval of the active substance dimethoate  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 149, on 
dimethoate , is del eted.  
Article 3 
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
dimethoate  as active substance by [ Office of Publications please insert date 6 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 12 months  from the date of e ntry into force]  at the latest.  
Article 5  
Entry into force  
This Regulation shall enter into force on the third day following that of its publication in the 
Official Journal of the European Union . 
                                                 
7 Commission Implementing Regulation (EU) 2018/917 of 27 June 2018 amending  Implementing 
Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 
alpha -cypermethrin, beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, 
carvone, chlorpropham, cyazofamid, d esmedipham, dimethoate, dimethomorph, diquat, ethephon, 
ethoprophos, etoxazole, famoxadone, fenamidone, fenamiphos, flumioxazine, fluoxastrobin, folpet, 
foramsulfuron, formetanate, Gliocladium catenulatum strain: J1446, isoxaflutole, metalaxyl -m, 
methiocar b, methoxyfenozide, metribuzin, milbemectin, oxasulfuron, Paecilomyces lilacinus strain 251, 
phenmedipham, phosmet, pirimiphos -methyl, propamocarb, pro thioconazole, pymetrozine and 
s-metolachlor . OJ L 163, 28.6.2018, p. 13 –16. 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