EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10935/2018 rev.1  
[…](2018) 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 
2,5-dichlorobenzoic acid methylester, mandipropamid, prochloraz and profoxydim in or 
on certain products  
(Text with EEA relevance)   EN 2  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 
2,5-dichlorobenzoic acid methylester, mandipropamid, prochloraz and profoxydim 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) , Article 18(1)(b)  and Article  49(2) thereof,  
Whereas:  
(1) For mandipropamid  and profoxydim  maximum residue levels ( MRLs ) were set in 
Part A of Annex  III to Regulation (EC) No  396/2005.  For prochloraz , MRLs were set 
in Annex  II and Part  B of Annex  III to Regulation (EC) No  396/2005. For 
2,5-dichlorobenzoic acid methylester  no MRLs are set in Regulation (EC) 
No 396/2005, and as th is active substance  is not included in Annex  IV to that 
Regulation, the default value of 0,01  mg/kg laid down in Article  18(1)(b) of that 
Regulation applies.  
(2) For 2,5-dichlorobenzoic acid methylester , 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  396/2005 . The Authority concluded that   
residues of 2,5 -dichlorobenzoic acid methylester are not expected to occur in any plant 
or animal commodities since its unique and restricted use as a pesticide in wine grapes 
after grafting is not  expected to result in significant residues in wine grapes It is 
therefore appropriate to set the MRLs at the default limit of determination. These 
default values should be set in Annex  V to Regulation (EC) No  396/2005.  
(3) For mandipropamid , the Authority sub mitted a reasoned opinion on the existing MRLs 
in accordance with Article  12(1) of Regulation (EC) No  396/20052. The Authority 
proposed to change the residue definition to mandipropamid (any ratio of constituent  
isomers) . It recommended raising or keeping the existing MRLs. It concluded that 
concerning the MRLs for  potatoes , onions , spring onions/green onions and Welsh 
onions , tomatoes  and courgettes, 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 
                                                 
1 OJ L 70 , 16.3.2005 , p. 1. 
2 European Food Safety Authority ; Review of the existing maximum residue levels for mandipropamid  
according to Article  12 of Regulation (EC) No  396/2005. EFSA Journal 2018;16(5):5284 . EN 3  EN the existing level or the level identified by the Authority. These MRLs will be 
reviewed; the review will take into account the information av ailable within two years 
from the publication of this Regulation.  
(4) For prochloraz , the Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article  12(1) of Regulation (EC) No  396/20053. The Authority  
proposed  to change the residue  definition to sum of prochloraz, BTS  44595 (M201 -04) 
and BTS  44596 (M201 -03), expressed as prochloraz . The Authority identified a risk 
for consumers concerning the MRL s for citrus fruits , kiwi, bananas, mangoes, 
pineapples  and bovine live r. It is therefore appropriate to lower th ese MRL s. It 
recommended  lowering the MRLs for   garlic, shallots, lettuces and salad plants , 
purslanes , herbs and edible flowers , peas, l inseeds , sunflower seeds, rapeseeds/canola 
seeds, barley, oat, rice, rye, wheat, coffe e beans, herbal infusions from flowers , leaves 
and herbs  and roots , spices, s ugar beet roots , bovine (fat tissue  and kidney)  and equine  
fat tissue, and poultry liver. It concluded that concerning the Codex maximum residue 
levels (CXLs)  for kumquats, lychi s/lychees, passion fruits/maracujas, prickly 
pears/cactus fruits, star apples/cainitos, American persimmons/Virginia kaki, 
avocadoes, papayas, Granate apples/pomegranates, cherimoyas, guavas, bread fruits, 
durians and soursops/guanabanas, some information was not available in relation with 
the new residue definition and that further consideration by risk managers was needed , 
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 level or the CXL s. These MRLs will be 
reviewed; the review will take into account the information available within two years 
from  the publication of this Regulation.  
(5) For profoxydim , the Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article  12(1) of Regulation (EC) No  396/20054. It recommended 
keeping the existing MRLs.  
(6) As regards products on which th e use of the plant protection product s concerned is not 
authorised, and for which no import tolerances or CXLs exist, MRLs should  be set at 
the specific limit of determination or the default MRL should apply, as provided for in 
Article  18(1)(b) of Regulati on (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 co mmodities technical 
development 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 requirements 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  396/20 05 should therefore be amended accordingly.  
(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 
                                                 
3 European Food Safety Authority ; Review of the existing maximum residue levels for prochloraz 
according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2018; ;16(8):5401 . 
4 European Food Safety Authority ; Review of the existing maximum residue levels for profoxydim 
according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2018;16(5):5282 . EN 4  EN been produced before the modification of the MRLs and for which information shows 
that a high level of con sumer 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 themselves 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 REGULATION:  
Article 1  
Annexes II , III and V  to Regulation (EC) No  396/2005 are amended in accordance with the 
Annex to this Regulation.  
Article 2  
As regards the active substances mandipropamid and profoxydim in and on all products, 
Regulati on (EC) No 396/2005 as it stood before being amended by this Regulation shall 
continue to apply to products which were produced in the U nion or imported into the U nion 
before [ Office of Publications : please insert date 6  months after entry into force of th is 
Regulation ]. 
As regards the active substance prochloraz  in and on all products except citrus fruits kiwi, 
bananas, mangoes, pineapples and bovine liver, 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 6  months after entry into force of this Regulat ion].  
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