EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10118/2020 Rev. 2  
[…](2020) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and III to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for imidacloprid in or 
on certain products  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 0  EN   
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and III to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for imidacloprid in or 
on certain products  
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/EEC  (1), and in particular 
Article  14(1)(a)  and Article 49(2) thereof,  
Whereas:  
(1) Maximum residue levels (MRLs) for imidacloprid were set in  Part A of  Annex III to 
Regulation (EC) No 396/2005.  
(2) The European Food Safety Authority ( "the Authority" ) submitted a reasoned opinion 
on the review of  the existing MRLs for imidacloprid in accordance with Article  12(1) 
of Regulation (EC) No  396/2005  (2). The Authority recommended setting the  residue 
definition as imidacloprid only. It identified a risk for consumers concerning the 
MRLs for escaroles. It i s therefore appropriate to lower this MRL to the limit of 
determination (LOD). The Authority  recommended lowering the MRLs for  pecans, 
bananas, tomatoes, s weet peppers/bell peppers , aubergines/eggplants, cucumbers, 
gherkins, courgettes and products of animal origin -terrestrial animals . The MRLs for 
those products should be set in Annex  II to Regulation (EC) No  396/2005 at the level 
identified by the Authority . 
(3) The Authority concluded th at concerning the MRL s for citrus fruits, grapes, 
blueberries, cranberries, okra/lady’s fingers, cucurbits with inedible peel, beans (with 
and without pods), peas (with and without pods), beans, peanuts/groundnuts, coffee 
beans and hops  some information wa s not available and that further consideration by 
risk managers was required . As there is no risk for consumers, the MRLs for those 
products should also be set in Annex  II to Regulation (EC) No  396/2005 at the level 
identified by the Authority. These MRLs will be reviewed; the review will take into 
account the information available within two years from the publication of this 
Regulation.  
(4) Existing Codex maximum residue limits (CXLs)  were taken into account in the 
reasoned opinions of the Authority. The Auth ority concluded that concerning the 
CXLs some information was not available in relation to the new residue definition 
and recommended not to include the existing CXLs in Annex II to Regulation (EC) 
                                                 
1 OJ L 070, 16.3.2005 , p. 1.  
2 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for imidacloprid  according to Article 12 of Regulation (E C) No 396/2005. EFSA Journal 
2019;17(1):5570.  
EN 2  EN No 396/2005. It is therefore appropriate to set those MRLs  to the level identif ied by 
the Authority.  
(5) As regards products on which the use of the plant protection product concerned is not 
authorised, and for which no import tolerances or CXLs  exist, MRLs should be set at 
the specific LOD  or the default MRL should apply, as provided for in Article 
18(1)(b) of Regulation (EC) No  396/2005.  
(6) The Commission consulted the European Union reference laboratories for residues of 
pesticides as regards the need to adapt certain limits of determination. Those 
laboratories conclu ded that for certain commodities technical development requires 
the setting of specific LOD . 
(7) Based on the reasoned opinions of the Authority and taking into account the factors 
relevant to the matter under consideration, the appropriate modifications to th e 
MRLs fulfil the requirements of Article  14(2) of Regulation (EC) No  396/2005.  
(8) 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.  
(9) Regulation (EC) No 396/2 005 should therefore be amended accordingly.  
(10) In order to allow for the normal marketing, processing and consumption of products, 
this Regulation should provide for a transitional arrangement for products which 
have been produced before the modification of the MRLs and for which information 
shows that a high level of consumer protection is maintained.  
(11) 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.  
(12) 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  
Annexes II  and III to Regulation (EC) No 396/2005 are amended in accordance with the 
Annex to this Regulation.  
Article 2  
As regards the active substance imidacloprid in and on all products except escaroles, 
Regulation  (EC) No 396/2005 as it stood before being amended by this Regulation shall 
continue to apply to products which were produced in the Union or imported into the Union 
before [ Office of Publication: please insert date 6 months after entry into force ].  
Article 3  
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] .  
EN 3  EN This Re gulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN