EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/11337/2018 Rev. 2  
[…](2018) 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 cyflufenamid, 
fenbuconazole, fluquinconazole and tembotrione in or on certain products  
(Text with EEA relevance)   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 cyflufenamid, 
fenbuconazole, fluquinconazole and tembotrione 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 
Articl e 14(1)(a)  and Article  49(2) thereof,  
Whereas:  
(1) For cyflufenamid , fenbuconazole , fluquinconazole and tembotrione maximum 
residue levels (MRLs) were set in Part A of Annex III to Regulation (EC) 
No 396/2005.  
(2) For cyflufenamid  the European Food Safety Authority ( "the Authority" ) submitted a 
reasoned opinion on the existing MRLs in accordance with Article  12(1) of 
Regulation (EC) No  396/20052. It proposed to change the residue definition for 
commodities of animal origin. It recommended lowering the MRLs for gherkins  and 
rye. For other products,  it recommended raising or keeping the existing MRLs.  It 
concluded that concerning the MRLs for maize/corn, common millet/proso millet, 
rice, sorghum, wheat and poultry (muscle, fat, liver) some  information was not 
available and that further consideration by risk managers was required. As there is no 
risk for consumers, the MRLs for those products should be set in Annex  II to 
Regulation (EC) No  396/2005 at the existing level or the level identifi ed 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.  
(3) For fenbuconazole  the Authority submitted a reasoned opinion on the existing MRLs 
in acc ordance with Article 12(1) of Regulation (EC) No 396/20053. It proposed to 
change the residue definition. It recommended lowering the MRLs for grapefruit, 
oranges, almonds, Brazil nuts, cashew nuts, chestnuts, coconuts, hazelnuts, 
macadamia, pecans, pine nuts, pistachios, walnuts and blueberries. For other 
products,  the Authority recommended raising or keeping  the existing MRLs.  It 
                                                 
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 cyflufenamid  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2018;16(1):5 416. 
3 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for fenbuconazole  according to Article 12 of Regulation (EC) No 3 96/2005. EFSA Journal 
2018;16(8):5399. EN 2  EN concluded that concerning the MRLs for apricots, p eaches, plums, cucumbers, 
gherkins, courgettes, melons, pumpkins and watermelons some  information was not 
available and that further consideration by risk managers was required. As there is no 
risk for consumers, the MRLs for those products should be set i n Annex  II to 
Regulation (EC) No  396/2005 at the existing level or  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) For fluquinconazole  the Authority submitted a reasoned opinion on the existing 
MRLs in accordance with Article 12(1) of Regulation (EC) No 396/20054. The 
Authority concluded that n o uses or import tolerances are currently authorised for 
fluquinconazole in the  Union  and no codex maximum residue limits (CXLs) are 
available for that active substance . Residues of ﬂuquinconazole are therefore not 
expected to occur in any plant commodity or in any animal product.  As there is no 
risk for consumers, the MRLs  for fluquiconazole  should be set in Annex  II to 
Regulation (EC) No  396/2005 at the specific limit of determination (LOD).  
(5) For tembotrione  the Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article  12(1) of Regulation (EC) N o 396/20055. It recommended 
lowering the MRLs for swine (liver, kidney), bovine (liver, kidney) and equine 
(liver, kidney). For other products,  the Authority recommended raising or keeping  
the existing MRLs . It concluded that concerning the MRLs for sweet corn and fruit 
spices some  information was not available and that further consideration by risk 
managers was required.  As there is no risk for consumers, the MRLs for those 
products should be set in Annex  II to Regulation (EC) No  396/2005 at the existing 
level or 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.  
(6) As regards products on which the use of the plant protection p roduct 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.  
(7) The Commission consulted the European Union reference laboratories for residues of 
pesticides as regards the need to adapt certain limits of determination. As regards 
several substances, those laboratories concluded that for certain commodities 
technical d evelopment requires the setting of specific limits of determination.  
(8) Based on the reasoned opinions of the Authority and taking into account the factors 
relevant to the matter under consideration, the appropriate modifications to the 
MRLs fulfil the requir ements of Article  14(2) of Regulation (EC) No  396/2005.  
(9) 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.  
(10) Regulation (EC) No 396/2005 should therefore be amended accordingly.  
                                                 
4 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for fluquinconazole  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2018;16(9):5409. 
5 Europ ean Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for tembotrione  according to Article 12 of Regulation (EC ) No 396/2005. EFSA Journal 
2018;16(9):5417. EN 3  EN (11) 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 i nformation 
shows that a high level of consumer protection is maintained.  
(12) 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 the mselves to meet the new requirements which will result from 
the modification of the MRLs.  
(13) 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 REGULATI ON: 
Article 1  
Annexes II  and III to Regulation (EC) No 396/2005 are 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 Publications please insert date of application 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: 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 JUNCKER