EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12380/2019 Rev. 1  
[…](2019) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and V to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for chlorpyrifos and 
chlorpyrifos -methyl in or on certain products  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and V to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for chlorpyrifos and 
chlorpyrifos -methyl in or on certain products  
(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)  and Article 1 8(1)(b) thereof,  
Whereas:  
(1) For chlorpyrifos and chlorpyrifos -methyl , maximum residue levels (MRLs) were set in 
Annex  II to Regulation (EC) No  396/2005.  
(2) The approval s of the active substance s chlorpyrifos and chlorpyrifos -methyl  were  not 
renewed by Commission Implementing Regulation (EU) 2020 /XXX2 and Commission 
Implementing Regulation (EU) 2020 /YYY3, respectively . 
(3) All existing authorisations for plant protection products containing chlorpyrifos and 
chlorpyrifos -methyl have been revoked. It is therefore appropriate to delete the MRLs 
set out for these substances in Annex II to Regulation (EC) No 396/2005 in 
accordance with Article 17 of Regulation (EC) No 396/2005 in conjunction with 
Article 14(1)(a) thereof and set them at the re levant limit of determination (LOD) in 
accordance with Article 18 (1)(b) of Regulation (EC) No 396/2005 . 
(4) The Commission consulted the European Union reference laboratories as regards the 
need to adapt certain LODs  for the two substances . Those laboratories  concluded that 
technical development permits the setting of LOD s at 0.01  mg/kg  for chlorpyrifos and 
chlorpyrifos -methyl  in all products. Those default values should be listed in Annex  V 
in accordance with Article  18(1)(b) of Regulation (EC) No  396/2005.  
                                                 
1 OJ L 70, 16.3.2005, p. 1.  
2 Commission Implementing Regulation (EU) 2020 /XXX of xx January 2020  concerning the non -
renewal of approval of the active substance chlorpyrifos , in acc ordance 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 Comm ission Implementing Regulation (EU) No 540/2011  
(OJ L xxx, xxxxxx).  
3 Commission Implementing Regulation (EU) 2020 /YYY of xx January 2020  concerning the non -
renewal of approval of the active substance chlorpyrifos -methyl , 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 Commission Implementing Regulation (EU) No 540/2011  
(OJ L xxx, xxxxxx ).  
EN 2  EN (5) In the context of the non -renewal of the approval of chlorpyrifos and chlorpyrifos -
methyl , the European Food Safety Authority ('the Authority') published statements on 
the human health assessment for those active substances4 5. In th ose statements  the 
Autho rity confirmed developmental neurotoxicity of both active substances in children 
and could not exclude a  genotoxic potential  due to the exposure to residues of the two 
substances  in food .  
(6) 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.  
(7) Regulation (EC) No  396/2005 should therefore be amended accordingly.  
(8) A reasonable period should be allowed to elapse before the modified MRLs become 
applicable in order t o 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.  
(9) The measures provided for in this Regulation are in accordance with the opinion of t he 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annexes II and V to Regulation (EC) No  396/2005 are 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 3 months after entry into force ]. 
This Regulation shall be binding in its entirety and direct ly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
The President  
                                                 
4 Statement on the available outcomes of the  human health assessment in the context of the pesticides 
peer review of the active substance chlorpyrifos . EFSA Journal 2019;17(5):5809 . 
5 Statement on the available outcomes of the human health assessment in the context of the pesticides 
peer review of the active substance chlorpyrifos -methyl . EFSA Journal 2019;17(5):5810 .