EN   EN  
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11242/2019 Rev. 1  
[…](2019) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II to Regulation (EC) No  396/2005 of the European Parliament and of 
the Council as regards maximum residue levels for dimethoate and omethoate in or on 
cherries  
(Text with EEA relevance)  
 EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX 
amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of 
the Council as regards maximum residue levels for dimethoate and omethoate in or on 
cherries  
(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 396/2005 of the European Parliament and of the 
Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed 
of plant and animal origin and amending Council Directive 91/414/EEC1, and in particular 
Article 14(1)(a)  thereof,  
Whereas:  
(1) For dimethoate and omethoate , maximum residue levels (MRLs) were set in Annex  II 
to Regulation (EC) No 396/2005.  
(2) The approval of the active substance dimethoate  was not renewed by Commission 
Implementing Regulation (EU) 2019 /10902.  
(3) All existing authorisations for plant protection products containing dimethoate  have 
been revoked  in relation to uses on cherries. It is therefore appropriate to delete the 
MRLs for cherries set out for dimethoate and omethoate  in Annex II of Regulation 
(EC) No 396/2005 in accordance with Article 17 of Regulation (EC) No 396/2005 in 
conjunction with Article  14(1)(a) thereof.  
(4) In the context of the non- renewal of the approval of dimethoate, the European Food 
Safety Authority ('the Authority') delivered a conc lusion on the peer review of the 
pesticide risk assessment of th at active substance3. In that framework, the Authority 
could not  exclude a risk to consumers due to the exposure to residues of dimethoate, for 
which the genotoxic potential could not be excluded, and to its main metabolite 
omethoate which was concluded to be an in vivo mutagenic agent.  
(5) Through the World Trade Organisation, the trading partners of the Union were 
consulted on the new MRLs and their comments have been taken into account. 
(6) Regulat ion (EC) No  396/2005 should therefore be amended accordingly.  
                                                 
1 OJ L 70, 16.3.2005, p. 1.  
2 Commission Implementing Regulation (EU) 201 9/1090  of 26 June 201 9 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 (OJ L 
173, 27.6.2019, p. 39).  
3 EFSA (European Food Saf ety Authority), 2018. Conclusion on the peer review of the pesticide risk 
assessment of the active substance dimethoate, EFSA Journal 2018;16(10):5454. 
https://www.efsa.europa.eu/en/efsajou rnal/pub/5454.   EN 2  EN (7) A reasonable period should be allowed to elapse before the modified MRLs become 
applicable in order to permit Member States, third countries and food business 
operators to prepare themselves to meet the new requirements which will result from 
the modification of the MRLs.  
(8) 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 
Annex II  to Regulation (EC) No 396/2005 is amended in accordance with the Annex to this 
Regulation.  
Article 2  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union.  
It shall apply from [ Office of Publication: please insert date 6 months after entry into force ]. 
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 J UNCKER