EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2022/2563 Rev.5  
[…](2023) 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 2,4 -DB, iodosulfuron -methyl, 
mesotrione and pyraflufen -ethyl in or on certain products  
(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 2,4 -DB, iodosulfuron -methyl, 
mesotrione and pyraflufen -ethyl in or on certain products  
(Text with EEA relevance)  
THE EUROPE AN 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 49(2) thereof,  
Whereas:  
(1) For 2,4-DB, iodosulfuron -methyl , mesotrione  and pyraflufen -ethyl,  maximum residue 
levels ( ‘MRLs ’) were set in Annex  II to Regulation (EC) No  396/2005.  
(2) During the review of  those MRLs  pursuant to  Article 12 of Regulation (EC) 
No 396/2005 , the European Food Safety Authority (‘the Authority ’) identified some 
information as unavailable for cer tain product s. The available information was 
sufficient for the Authority to propose MRLs that are safe for consumers . Data gaps 
were indicated  in Annex II to that Regulation specifying  the date by which th e missing  
information was to be submitted to the Authority by the applicant in support of the 
proposed MRL s. 
(3) For 2,4 -DB, the missing information concerning  its metabolism and analytical 
methods  for barley , oats, rye and wheat was submitted  by the applicant  and the 
Authori ty concluded that the data gap  indicated in Annex II to Regulation (EC) No 
396/2005  was sufficiently addressed2. Therefore, for these products , the existing 
MRLs in Annex II to Regulation (EC) No  396/2005 should be maintained, and the 
footnote requiring the submission of additional information should be deleted from 
that Annex . For swine  (muscle, fat, liver, kidney),  bovine (muscle, fat, liver, kidney , 
edible offals ), sheep (muscle, fat, liver, kidney, edible offals), goat (muscle, fat,  liver, 
kidney, edible offals) , equine (muscle, fat, liver, kidney, edible offals) , other farmed 
terrestrial animal s (muscle, fat, liver, kidney, edible offals) and milk (cattle, sheep, 
goat, horse) , although infor mation on analytical methods was submitted  by the 
applicant, a  feeding study for ruminants  is still missing. T he Authority concluded that  
this information  was not sufficient to address  the data gap  previously identified  and 
recommended that risk managers consider lowering  the MRLs  for those produc ts to 
the limit of determination ( ‘LOD ’)2. Therefore, it is appropriate to set the MRLs for 
 
1 OJ L 70, 16.3.2005, p. 1.  
2 European Food Safety Authority; ‘Lack of confirmatory data following Article 12 MRL reviews for 
2,4-DB, iodosulfuron -methyl, mesotrione, methoxyfenozide and pyraflufen -ethyl’, EFSA Journal, 
2023;21(5):8013 .  
EN 2  EN those products in Annex  II to Regulation (EC) No  396/2005 at the product -specific 
LOD , and to delete the footnote indicating a request for a submission additional 
information from that Annex . 
(4) For iodosulfuron -methyl , the missing information concerning  storage stability, crop 
metabolism and residue trials for linseeds and residue trials for maize/corn was  not 
submitted by the applicant . The Authority therefore concluded that the data gap 
previously identified was not addressed3, and recommended that risk managers 
consider lowering those MRLs to the LOD . Therefore, for these products , it is 
appropriate to set t he MRLs in Annex  II to Regulation (EC) No  396/2005 at the 
product -specific LOD , and to delete the [footnote indicating a] request for the 
submission of additional information from that Annex.   
(5) For mesotrione , the missing  information on residue trials investigating residue levels 
of that substance and its metabolite AMBA (free and conjugate) for sugar canes was 
not submitted by the applicant. T he Authority therefore concluded that the data gap 
previously identified was not addressed4, and recommended that risk managers 
consider lowering that MRL to the LOD . Therefore, for sugar cane s, it is appropriate 
to set the MRL in Annex  II to Regulation (EC) No  396/2005 at the product -specific 
LOD , and to delete the requirement to submit additional information from that Annex.   
(6) For pyraflufen -ethyl , the missing information concerning analytical methods for hops  
was not submitted by the applicant . The Authority therefore concluded that the data 
gap previously identified was not addressed5, and recommended that risk managers 
consider lowering that MRL to the LOD . Therefore, for hops , it is appropriate to set 
the MRL in Annex  II to Regulation (EC) No  396/2005 at the product -specific LOD , 
and to delete the requirement to submit additional informati on from that Anne x. 
(7) The Commission consulted the European Union reference laboratories as regards the 
need to adapt certain LODs. Those laboratories concluded that for certain products 
technical development s permit the setting of lower LODs.  
(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  396/2005 should therefore be amended accordingly.  
(10) In order to allow for the normal marketing, pro cessing and consumption of products, 
this Regulation should provide for a transitional measure for products which have been 
produced before the modification of the MRLs and for which it has been shown 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 adapt themselves to the requirements which result from the modification 
of the MRL s.  
 
3 European Food Safety Authority; ‘Lack of confir matory data following Article 12 MRL reviews for 
2,4-DB, iodosulfuron -methyl, mesotrione, methoxyfenozide and pyraflufen -ethyl’, EFSA Journal, 
2023;21(5):8013.  
4 European Food Safety Authority; ‘Lack of confirmatory data following Article 12 MRL reviews for 
2,4-DB, iodosulfuron -methyl, mesotrione, methoxyfenozide and pyraflufen -ethyl’, EFSA Journal, 
2023;21(5):8013.  
5 European Food Safety Authority; ‘Lack of confirmatory data following Article 12  MRL reviews for 
2,4-DB, iodosulfuron -methyl, mesotrione, methoxyfenozide and pyraflufen -ethyl’, EFSA Journal, 
2023;21(5):8013.   
EN 3  EN (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  
Annex  II to Regulation (EC) No  396/2005 is amended in accordance with the Annex to this 
Regulation.  
Article 2  
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 Public ation s: please insert date 6   months after date of entry into force  of 
this regulation ]. 
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 s: please insert date 6 months after date of entry into 
force  of this reg ulation ]. 
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