EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10644/2021 rev.03  
[…](2020) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for bifenthrin, 
bromopropylate, chloridazon, fenpropimorph, imazaquin and tralkoxydim in or on 
certain products  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for bifenthrin, 
bromopropylate, chloridazon, fenpropimorph, imazaquin and tralkoxydim 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 18(1)(b) thereof,  
Whereas:  
(1) For bifenthrin, chloridazon, fenpropimorph and tralkoxydim , maximum residue levels 
(‘MRLs’) were set in Annex  II to Regulation (EC) No  396/2005. For bromopropylate , 
MRLs were set , in Annex II and Part B of Annex III to that Regulation  depending on 
the product . For imazaqui n, MRLs were set in Part  A of Annex  III to that Regulation.  
(2) Bromopropylate  has never been approved in the Union as an active substance  in plant 
protection products . MRLs are established at the limit of determination (LOD ). MRLs 
for that substance should therefore be moved into Annex V to Regulation (EC) No 
396/2005 . 
(3) The approval of the active substance bifenthrin  expired on 31 July 20192. The 
approval s of the active substance s chloridazon  and imazaquin  expired on 
31 December  2018, those of  fenpropimorph and tralkoxydim  on 30  April  20193.  
(4) All existing authorisations for plant protection products containing th ose active 
substances have been revoked. It i s therefore appropriate to delete the existing MRLs 
set out for th ose substances in Annexes II and III of Regulation (EC) No 396/2005 in 
accordance with Article 17 of that Regulation in conjunctio n with Article 14(1)(a) 
thereof. Some MRLs can be maintained , in particular those that  are based on import 
tolerance requests  that are safe for consumers and those MRL that are based on Codex 
maximum residue limits ( ‘CXLs’) which  were not established on the basis of now 
obsolete U nion uses and that are safe for consumers.  
                                                 
1 OJ L 70, 16.3.2005, p. 1.  
2 Commission Implementing Regulation (EC) No 2019/324 of 25 February 2019 amending Implementing 
Regulation (EU) No 540/2011 as regards the approval periods of the active substances bifenthrin, 
carboxin, FEN 560 (also called fenugreek or fenugreek seed powder ), pepper dust extraction residue 
and sodium aluminium silicate  (OJ L 57, 26.2.2019, p. 1).  
3 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 rega rds the list of approved active 
substances (OJ L 153, 11.6.2011, p. 1).  EN 2  EN (5) The MRL s for bifenthrin in maize grain and sweet corn  correspond to import tolerance 
requests from the United States of America and are safe for consumers4. The MRLs 
for bifenthrin  in citrus fruits, tree  nuts, grapes, cane fruits , blueberries, b ananas, 
mangoes, papayas, potatoes, tropical root and tuber veg etables , other root and tuber 
vegetables , tomatoes, pep pers, aubergines, okra, brassicas, baby leaf crops, peas with 
and without pods, pulses, rapeseeds, soyabeans, cotton seeds, wheat, te as, h ops, fruit 
and root spices and all tissues from  mammals  correspond to CXLs that are safe for 
consumers45. Those MRLs should be maintained at the existing levels.  The applicant 
submitted information previously unavailable during the review conducted in 
accordance with Article 12 of Regulation (EC) No  396/2005 on storage stability for 
bifenthrin in citrus fruits , cane fruits  and bird eggs , the MRLs are fully supported by 
data4. Therefore, the respective footnotes  highlighting the need for additional data can 
be deleted.  As recent  monitoring data for herbal infusions showed that a lower MRL 
than 0,1  mg/kg is currently not achievable, those MRLs should be maintained and the 
respective footnotes can be deleted.  As regard strawberries, the existing CXL gives 
rise to consumer health concerns and should therefore be set to the LOD in  Annex II to 
Regulation (EC) No  396/20056. 
(6) The MRL for fenpropimorph in bananas corresponds to an import tolerance request 
from Venezuela and is safe for consumers7.  
(7) The Commission consu lted the European Union reference laboratories for residues of 
pesticides as regards the need to adapt certain LODs . Those laboratories recommended 
analytically achievable LODs for all substances and products .  
(8) Through the World Trade Organisation, the tra ding partners of the Union were 
consulted on the new MRLs and their comments have been taken into account.  
(9) Regulation (EC) No  396/2005 should therefore be amended accordingly.  
(10) 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.   
(11) 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, III  and V to Regulation (EC) No  396/2005 are amended in accordance with the 
Annex to this Regulation.  
                                                 
4 Evaluation of confirmatory data following the Article 12 MRL review and setting of import tolerances 
for bifenthrin in maize grain and sweet corn . EFSA Journal 2020;18(12):6361.  
5 Scientific and technical support for preparing a EU position in the 42nd Session of the Codex 
Committee on Pesticide Residues (CCPR). EFSA Journal 2010;8(11):1560.  
6 Scientific support for preparing an EU position for the 52nd Session of the Codex Committee  on 
Pesticide Residues (CCPR) . EFSA Journal 2021; 19 (8). https://doi.org/10.2903/j.efsa.2021.6766 .  
7 Reasoned opinion on the review of the existing maximum residue levels (MRLs) for fenpropimorph 
according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2015;13(3):4050 .  EN 3  EN Article 2  
This Regulatio n 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  
 Ursula VON DER LEYEN