EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11715/2017 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 bromadiolone, 
etofenprox, paclobutrazol and penconazole 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 bromadiolone, 
etofenprox, paclobutrazol and penconazole 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 Co uncil Directive 91/414/EEC1, and in particular 
Article  14(1)(a) , Article 18(1)(b)  and Article  49(2) thereof,  
Whereas:  
(1) For etofenprox and paclobutrazol maximum residue levels ( MRLs ) were set in Part A 
of Annex  III to Regulation (EC) No  396/2005.  For penconazole, MRLs were set in 
Annex  II and Part B of Annex  III to Regulation (EC) No  396/2005. For bromadiolone  
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 val ue of 0,01  mg/kg laid down in 
Article  18(1)(b) of that Regulation applies.  
(2) For bromadiolone , the European Food Safety Authority ("the Authority" ) submitted a 
reasoned opinion on the existing MRLs in accordance with Article  12(2) of Regulation 
(EC) No 396/2 005 in conjunction with Article  12(1) thereof2. All existing 
authorisations for plant protection products containing bromadiolone  are restricted to 
the use as rodenticide only and are not intended for direct application on edible crops. 
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 in 
accordance with Article 18(1)(b) of that Regulation.  
(3) For etofenprox, the Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article  12(2) of Regulation (EC) No 396/2005 in conjunction with 
Article  12(1) thereof3. The Authority  recommended lowering the MRLs for chestnuts, 
hazelnuts/cobnuts, apples, pears, apricots, cherries (sweet), plums, grapes, 
strawberries, blackberries, raspberries (red and yellow) , blueberries, c urrants (black, 
red and white) , gooseberries (gr een, red and yellow) , figs, kaki/Japanese persimmons , 
granate apples/pomegranates , potatoes, garlic, onions, tomatoes,  sweet peppers/bell 
peppers, aubergines/eggplants, Brussel sprouts, head cabbages , beans (with pods) , 
beans (without pods), lupins/lupine  beans (dry), cereals, s ugar beet roots , swine 
                                                 
1 OJ L 70 , 16.3.2005 , p. 1. 
2 European Food Safety Authority ; Review of the existing maximum residue levels for bromadiolone  
according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2017 ;15(5):4835 . 
3 European Food Safety Authority ; Review of the existing maximum residue levels for etofenprox  
according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2017;15(8):4964 .  
EN 3   EN (muscle , liver and kidney) , bovine (muscle , liver and kidney) , sheep (muscle , liver and 
kidney) , goat (muscle , liver and kidney) , equine  (muscle , liver and kidney) , other 
farmed terrestrial animals (muscle, li ver and kidney)  and milk (sheep and goat) . For 
other products, it recommended raising or keeping the existing MRLs. It concluded 
that concerning the MRLs for  grapefruits, oranges, lemons, limes, mandarins, peaches, 
kiwi fruits (green, red, yellow) , melons,  pumpkins, watermelons, l amb's lettuces/corn 
salads , lettuces, escaroles/broad -leaved endives, cresses and other sprouts and shoots, 
Roman rocket/rucola, spinaches, c hards/beet leaves , chervil, chives, celery leaves, 
parsley, sage, rosemary , thyme, basil and edible flowers, l aurel/bay leave , tarragon, 
lentils (fresh), beans (dry), rapeseeds/canola seeds,  fat tissue of swine, bovine, sheep 
goat and equine, poultry (muscle, fat tissue  and liver), milk (cattle, sheep, goat and 
horse) and b irds e ggs, 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.  
(4) For paclobutrazol , the Authority submitted a reasoned opinion on the existing M RLs 
in accordance with Article  12(2) of Regulation (EC) No  396/2005 in conjunction with 
Article  12(1) thereof4. The Authority  proposed  to change the residue definition to 
paclobutrazol (sum of constituent isomers). It recommended  lowering the MRLs for  
apples, pears, quinces, medlars, loquats/Japanese medlars, apricots, peaches, plums, 
grapes, table olives, linseeds, sesame seeds, rapeseeds/canola seeds, mustard seeds, 
borag e seeds, gold of pleasure seeds, hemp seeds , olives for oil production, bovine 
(muscle, fat tissue, liver and kidney)  and equine ( muscle, fat tissue, liver and kidney ). 
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.  
(5) For penconazole,  the Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article  12(2) of Regulation (EC) No  396/2005 in conjunction with 
Article  12(1) thereof5. The Authority proposed to change the residue definition to 
penconazole  (sum of cons tituent isomers). It recommended lowering the MRLs for  
almonds, h azelnuts/cobnuts , walnuts, apples, pears, quinces, medlars, loquats, 
apricots, strawberries, currants (black, red and white), cucumbers, gherkins, 
courgettes, peas  (with and without pods), gl obe artichokes, hops, bovine (muscle, fat 
tissue, liver and kidney) , equine (muscle, fat tissue, liver and kidney) , poultry (muscle, 
fat tissue, liver and kidney),  milk and bird eggs.  For other products, it recommended 
raising or keeping the existing MRLs.  It concluded that concerning the MRLs for 
cherries (sweet), peaches, plums, grapes, blackberries, raspberries (red and yellow), 
gooseberries (green, red and yellow) , sweet peppers/bell peppers, 
aubergines/eggplants, melons, pumpkins, watermelons some info rmation 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.  
                                                 
4 European Food Safety Authority ; Review of the existing maximum residue levels for paclobutrazol 
according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2017;15(8):4974 . 
5 European Food Safety Authority ; Review of the existing maximum residue levels for penconazole  
according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2017;15(6):4853 .  
EN 4   EN (6) As regards products on which the use of the plant protection product concerned is not 
authori sed, and for which no import tolerances or Codex maximum residue limits 
(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 Regulation (EC) 
No 396/2005.  
(7) The Commiss ion 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.  
(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  396/2005 should therefore be amended a ccordingly.  
(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 informatio n 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 t o 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:  
Artic le 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 etofenprox, paclobutrazol and penconazole in and on all 
products, 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 U nion or imported into the 
Union before [ Office of Publications : please insert date 6  mont hs 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 5   EN Done at Brussels,  
 For the Commission  
 The President  
Jean -Claude JUNCKER