EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10034/Rev. 3  
[…](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 benalaxyl, 
benalaxyl -M, dichlobenil, fluopicolide, proquinazid and pyridalyl 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 benalaxyl, 
benalaxyl -M, dichlobenil, fluopicolide, proquinazid and pyridalyl 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 benalaxyl and benalaxyl -M maximum residue levels (MRLs) were set in Annex  II 
and Part B of Annex III to Regulation (EC) No 396/2005. For fluopicolide, 
proquinazid and  pyridalyl MRLs were set in Part A of Annex III to Regulation (EC) 
No 396/2005.  For dichlobenil MRLs were set in Annex V to Regulation (EC) No 
396/2005.  
(2) For benalaxyl and benalaxyl -M the European Food Safety Authority ( ‘the Authority ’), 
submitted a reasoned opinion on the review of the existing MRLs in accordance with 
Article  12(1) of Regulation (EC) No  396/20052. It took into account a previous review 
for benalaxyl3. For some products t he Authority  recommended raising or keeping the 
existing MRLs . The MRLs for those products should be set in Annex  II to Regulation 
(EC) No  396/2005 at the level identified by the Authority. The Authority  concluded 
that concerning the MRLs for table grapes, potatoes, garlic, onions, shallots , lettuces 
and leeks some inf ormation was not available and that further consideration by risk 
managers was required. As there is no risk for consumers, the MRLs should be set in 
Annex  II to Regulation (EC) No  396/2005 at the level identified by the Authority. 
These MRLs will be revie wed; the review will take into account the information 
available within two years from the publication of this Regulation.   
                                                 
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 benalaxyl -M according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2019;17(9):5818 . 
3 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for benalaxyl  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2013;11(10):3405 . EN 2  EN (3) For dichlobenil the Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article 12(1) of Regulation (EC) No 396/2005 .4 As Dichlobenil is no 
longer approved in the EU and all authorisations for this substance have been revoked , 
the MRLs should remain in Annex V at the limit of determination (LOD).  
(4) For fluopicolide the Authority submitted a reasoned opinion on  the existing MRLs in 
accordance with Article 12(1) of Regulation (EC) No  396/20055. It recommended 
lowering the MRL for lettuces. For certain other products, it recommended raising or 
keeping the existing MRLs. The MRLs for those products should be set in Annex  II to 
Regulation (EC) No  396/2005 at the level identified by the Authority. The Authority 
concluded that concerning the MRLs for escaroles/broad -leaved endives , hops, swine 
(muscle, fat, liver, kidney), bo vine (muscle, fat, liver, kidney), sheep (muscle, fat, 
liver, kidney), goat (muscle, fat, liver, kidney), equine (muscle, fat, liver, kidney), 
poultry (muscle, fat, liver, kidney), other farmed terrestrial animals (muscle, fat, liver, 
kidney), milk (cattle , sheep, goat, horse) and birds’ eggs some information was not 
available and that further consideration by risk managers was required. As there is no 
risk for consumers, MRLs 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.  
(5) For proquinazid the Authority submitted a reasoned opinion on the exi sting MRLs in 
accordance with Article 12(1) of Regulation (EC) No  396/20056. It proposed to 
change the residue definition for commodities of animal origin and  recommended 
raising or keeping the existing MRLs  for certain products . The MRLs for those 
product s should be set in Annex  II to Regulation (EC) No  396/2005 at the level 
identified by the Authority.  It concluded  that concerning the MRLs  for barley, oats, 
bovine (muscle, fat, liver, kidney), sheep (muscle, fat, liver, kidney), goat (muscle, fat, 
liver, kidney) , equine (muscle, fat, liver, kidney)  and milk (cattle, sheep, goat, horse) 
some information was not available and that further consideration by risk managers 
was required. As there is no risk for consumers, MRLs should be set in Annex  II to 
Regulation (EC) No  396/2005 at the existing level or the level identified by the 
Authority.  These MRL s will be reviewed; the review will take into account the 
information available within two years from the publication of this Regulation.  
(6) For pyridalyl the  Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article 12(1) of Regulation (EC) No  396/20057. It recommended 
lowering the MRL  for sweet peppers/bell peppers. For  other products, the Authority 
recommended raising or keeping the existing MRLs. 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 .   
                                                 
4 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for dichlobenil  according to Article 12 of Regulation (EC) No 39 6/2005. EFSA Journal 
2013;11(5):3218 . 
5 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for fluopicolide  according to Article 12 of Regulation (EC ) No 396/2005. EFSA Journal 
2019;17(7):5748 . 
6 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for proquinazid  according to Article 12 of Regulation (EC ) No 396/2005. EFSA Journal 
2020;18(1):5987 . 
7 European Food Safety Authority; Reasoned opinion on the rev iew of the existing maximum residue 
levels for pyridalyl  according to Article 12 of Regulation (EC ) No 396/2005. EFSA Journal 
2019;17(9):5814 . EN 3  EN (7) As regards products on which the use of the plant protection product concerned is not 
authorised, and for which no import tolerances or Codex maximum residue limits 
(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.  
(8) The Commission consulte d 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 
development requires the  setting of specific limits of determination.  
(9) 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.  
(10) 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.  
(11) Regulation (EC) No 396/2005 should therefore be amended accordingly.  
(12) 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.  
(13) 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.  
(14) 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 I I, III and V  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 6  months after 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: please insert date 6 months after entry into force] . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  EN 4  EN Done at Brussels,  
 For the Commission  
The President  
Ursula VON DER LEYEN