EN   EN  
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10154/2018 Rev. 2  
[…](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 bromuconazole, 
carboxin, fenbutatin oxide, fenpyrazamine and pyridaben 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 bromuconazole, 
carboxin, fenbutatin oxide, fenpyrazamine and pyridaben in or on certain products  
(Text with EEA releva nce) 
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 bromuconazole, carboxin, fenpyrazamine and pyridaben  maximum residue leve ls 
(MRLs) were set in Part A of Annex II I to Regulation (EC) No 396/2005. For 
fenbutatin oxide  MRLs were set in Annex II and in Part B of Annex III to that 
Regulation.  
(2) For bromuconazole , 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 concluded that concerning the 
MRLs for rye, wheat, bovine (muscle, fat, liver, kidney), sheep (muscle, fat, liver, 
kidney) , goat (muscle, fat, liver, kidney), equine (muscle, fat, liver, kidney), poultry 
(muscle, fat, liver), 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, 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 
informatio n available within two years from the publication of this Regulation .  
(3) For carboxin , the Authority submitted a reasoned opinion on  the review  of the 
existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/20053. It 
proposed to change the r esidue definition and concluded that concerning the MRLs 
for all commodities  some information was not available and that further 
consideration by risk managers was required . As a  risk for consumers  cannot be 
excluded, the Authority recommended reducing  the MRLs for plant and animal 
                                                 
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 bromuconazole  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2017;15(9 ):4986. 
3 European Food Safety Authority; Reasoned opinion  on the review of the existing maximum residue 
levels for carboxin  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2017;15(10): 5019 . EN 2  EN  commodities to the relevant limit of determination (LOD). 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 f enbutatin oxide , the Authority submitted a reasoned opinion on the review  of 
the existing MRLs in accordance with Article 12(1) of Regulation (EC) 
No 396/20054. Commission Implementing Regulation (EU) No  486/20145 provides 
for withdrawing the approval of fenbutatin oxide,  as the further confirmatory 
information for this active substance required by Commission Directive 2011/30/EU6 
has not been submitted. All existing authorisations for plant protection products 
containing fenbutatin oxide have been revoked. In accordance w ith Article 17 of 
Regulation (EC) No 396/2005 in conjunction with Article 14(1)(a) thereof, the 
MRLs set out for fenbutatin oxide in Annex II and Part B of Annex III  to Regulation 
(EC) No 396/2005  should therefore be deleted . The Authority  did not recommen d 
maintaining  existing Codex maximum residue limits  (CXLs ) since  toxicological data 
for the active substance and its metabolite, di -hydroxy fenbutatin oxide , were not 
provided and the risk to consumers could not be assessed. The Authority 
recommended reduc ing the MRLs for plant and animal commodities to the relevant 
LOD s. These default values should be set in Annex  V to Regulation (EC) No 
396/2005 in accordance with Article 18(1)(b) of that Regulation.  
(5) For fenpyrazamine , the Authority submitted a reasoned opinion on  the review  of the 
existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/20057. 
For apricots, cherries, plums, table grapes, wine grapes, strawberries, blackberries, 
dewberries, raspberries ( red and yellow), blueberries, tomatoes, sweet peppers/bell 
peppers, aubergines/eggplants, cucumbers, gherkins and courgettes, the Authority 
recommended keeping the existing MRLs and it recommended increasing the MRL 
for peaches. T he Authority concluded tha t concerning the MRL  for almonds , some 
information was not available and that further consideration by risk managers was 
required.  This MRL  will be reviewed; the review will take into account the 
information available within two years from the publication of this Regulation . 
(6) For pyridaben , the Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article 12(1) of Regulation (EC) No 396/20058. It recommended 
lowering the MRLs for grapefruits, oranges, lemons, limes and mandarins and 
strawberries and keeping the existing MRLs for cucumbers, gherkins and courgettes. 
                                                 
4 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
level s for fenbutatin oxide  according to Article 12 of Regulation (EC ) No 396/2005. EFSA Journal 
2017;15(12):5091 . 
5 Commission Implementing Regulation (EU) No 486/2014 of 12 May 2014 withdrawing the approval of 
the active substance fenbutatin oxide, in accorda nce with Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council concerning the placing of plant protection products on the 
market, and amending Commission Implementing Regulation (EU) No 540/2011  (OJ L 138, 13.5.2014, 
p. 70 ). 
6  Commiss ion Directive 2011/30/EU of 7 March 2011 amending Council Directive 91/414/EEC to 
include fenbutatin oxide as active substance and amending Commission Decision 2008/934/EC (OJ L 
61, 8.3.2011, p. 14).  
7  European Food Safety Authority; Reasoned opinion on t he review of the existing maximum residue 
levels for fenpyrazamine  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2017;15(1 2):5072, Modification of the existing maximum residue levels for fenpyrazamine  in lettuces, 
salad plants, spinaches and similar leaves . EFSA Journal 201 8;16(4):5231.  
8 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for pyridaben  according to Article 12 of Regulation (EC) No 396/ 2005. EFSA Journal 
2017;15(1 1):5054 . EN 3  EN  The Authority concluded that concerning the MRL s for apples, pears, quinces, 
medlars, loquats/Japanese medlars, apricots, peaches, tomatoes, 
aubergines/eggplants, beans with  pods, 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, the MRLs for those products should be set in Annex  II to 
Regulation (EC) No  396/2005 at 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 . The Authority concluded that 
concerning the MRLs for  plums, table grapes, wine grapes, currants (black, red and 
white), gooseberries (green, red and yellow) and sweet peppe rs/bell peppers , no 
information was available and that further consideration by risk managers was 
required. The MRLs for these products should be set at the specific LOD . 
(7) As regards products on which the use of the plant protection product 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.  
(8) 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 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 modificatio ns 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 modifica tion 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 b usiness 
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 . EN 4  EN  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  
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 s hall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
Jean -Claude JUNCKER