COMMI SSION IMPLEMENTING REGUL ATION (EU) 2019/1090 
of 26 June 2019 
concer ning the non-renewal of appro val of the activ e subst ance dimethoate, 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 2007/25/EC (2) included dimethoat e 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 dimethoat e, 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 dimethoate 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 
5 May 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 2 October 2018 the Authority communicate d to the Commission its conclusion (6) on whether dimethoat e 
can be expect ed to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The 
Commission present ed to the Standing Committee on Plants, Animal, Food and Feed the draf t renewal repor t for 
dimethoat e on 13 December 2018 and the draf t regulation on 25 Januar y 2019. 27.6.2019 L 173/39 Official Jour nal of the European Union EN     
(1)OJ L 309, 24.11.2009, p. 1. 
(2)Commission Directive 2007/25/EC of 23 Apr il 2007 amending Council Directive 91/414/EEC to include dimethoate, dimethomor ph, 
glufosinate, metr ibuzin, phosmet and propamocarb as active substances (OJ L 106, 24.4.2007, p. 34). 
(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 
dimethoate EFSA Jour nal 2018;16(10):5454. https://www .efsa.europa.eu/en/efsajournal/pub/5454 (9)  The Authority identif ied specifi c concer ns. In particular , it was not possible to exclude exposure risk to 
consumers, operat ors, workers, bystanders and residents due to their exposure to residues of dimethoat e, for 
whic h the genoto xic pote ntial could not be excluded, and its main metabolite omethoate whic h was concluded to 
be an in vivo mutagen ic agent by the major ity of exper ts in the peer review . Further more, the Author ity 
concluded that a high risk to mammals, and to non-target arthropods for dimethoate. and to hone ybees for both 
dimethoat e 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 suppor ted by the (eco) 
toxicological assessment 
(10)  The Commission invit ed the applicant to submit its comments on the conclusion of the Author ity. Further more, 
in accordance with 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 submitted their 
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. The appro val of the active substance dimethoat e should theref ore not be renewed. 
(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 dimethoate. 
(15)  For plant protection products containing dimethoat e, where Member State s grant any grace period in accordance 
with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest , expire on 17 October 2019 
for plant prot ection products used on cherries and on 17 July 2020 for plant protect ion products used on other 
crops. 
(16)  Commission Imple menting Regulation (EU) 2019/707 (7) exte nded the approval period of dimethoate to 31 July 
2020 in order to allow the renewal process to be compl eted before the expir y of the appro val period of that 
substance. Given that a decision on the non-renewal of the approval has been take n ahead of that exte nded 
expir y date, this Regulation should apply as soon as possible. 
(17)  This Regulation does not prevent the submission of a further application for the approval of dimethoate pursuant 
to Article 7 of Regulation (EC) No 1107/2009. 
(18)  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 appro val of activ e subst ance 
The approval of the active substance dimethoat e is not renewed. 27.6.2019 L 173/40 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, Paecilomy ces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole, 
s-meto lachlor and tebuconazole (OJ L 120, 8.5.2019, p. 16). 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 delet ed. 
Article 3 
Transitional measures 
Member States shall withdraw author isations for plant prot ection products containing dimethoate as active substance by 
17 Januar y 2020 at the lates t. 
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 17 October 2019 for plant protection products used on cherr ies and by 17 July 
2020 for plant protection products used on other crops, at the latest. 
Article 5 
Entr y into force 
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, 26 June 2019. 
For the Commission 
The President 
Jean-Claude JUNCK ER  27.6.2019 L 173/41 Official Jour nal of the European Union EN