EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10482/2018 Rev. 4  
[…](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 bispyribac, 
denatonium benzoate, fenoxycarb, flurochloridone, quizalofop -P-ethyl, 
quizalofop -P-tefuryl, propaquiz afop, tebufenozide 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 bispyribac, 
denatonium benzoate, fenoxycarb, flurochloridone, quizalofop -P-ethyl, 
quizalofop -P-tefuryl, propaquizafop, tebufenozide in or on certain products  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regar d 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 orig in and amending Council Directive  91/414/EEC1, and in particular 
Article  14(1)(a)  and Article  49(2)  thereof,  
Whereas:  
(1) For fenoxycarb,  flurochloridone, propaquizafop and tebuf enozide maximum residue 
levels  (''MRLs '') were set in Part  A of Annex  III to Regulation (EC) No  396/2005. 
For quizalofop -P-ethyl and quizalofop -P-tefuryl , expressed as quizalofop, including 
quizalofop -P, MRLs were set in Part A of Annex III to Regulation (EC) 
No 396/2005 . For bispyribac and denatonium benzoate no MRLs were  set in 
Regulation (EC) No  396/2005, and as th ese active substance s are  not included in 
Annex  IV to that Reg ulation, the default value of 0 .01 mg/kg laid down in 
Article  18(1)(b) of Regulation (EC) No  396/2005  applies.  
(2) For bispyribac  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 recommended  setting  a MRL for rice. No other 
authorisations exist for this substa nce. As there is no risk for consumers,  the MRLs 
for all other commodities should be set in Annex  II to Regulation (EC) No  396/2005 
at the specific limit of determination (LOD).    
(3) For denatonium benzoate  the Authority submitted a reasoned opinion on the ex isting 
MRLs in accordance with Article  12(1) of Regulation (EC) No  396/20053. All 
existing authorisations for plant protection products containing denatonium benzoate  
are restricted only to use s as repellent  in forestry and are not intended for direct 
application on edible crops. As there is no risk for consumers, MRLs should be set in 
Annex  II to Regulation (EC) No  396/2005 at the specific LOD . 
                                                 
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 bispyribac  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2018;16(1):5142 . 
3 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for denathonium benzoate  according to Article 12 of Regulation (EC) No 396/2005. EFSA 
Journal 201 8;16(3):5232 . EN 2  EN (4) For fenoxycarb the Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article  12(1) of Regulation (EC) No  396/20054. It recommended 
lowering the MRLs f or apples, pears, quinces, medlars, loquats /Japanese medlars , 
plums, table grapes, wine grapes, bovine (muscle, fat, liver, kidney), sheep (muscle, 
fat, liver, kidney), goat (muscle, fat, l iver, kidney), horse (muscle, fat, liver, kidney)  
and milk (cattle, sheep, goat, horse) . For other products, it recommended keeping the 
existing MRLs.  The Authority concluded that concerning the MRL s for oranges, 
lemons, mandarins, apricots  and table olive s 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.  
(5) For flurochloridone  the Authority submitted a reasoned opinion on the existing 
MRLs in accordance with Article  12(1) of Regulation (EC) No  396/20055. The 
Authority  proposed to change the residue definition. It recommended lowering the 
MRLs for potatoes, carrots, celeriacs/turnip rooted celeries, parsnips, sunflower 
seeds and cotton seeds . It concluded that concerning the MRL s for parsley 
roots/hamburg roots parsley, maize/corn, wheat , swine (meat, fat, liver, kidney), 
bovine (meat, fat, liver, kidney), sheep (meat, fat, liver, kidney), goat (meat, fat, 
liver, kidney), horse (meat, fat, liver, kidney), m ilk (sheep, goat) 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 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.   
(6) For quizalofop -P-ethyl, quizalofop -P-tefuryl and propaquizafop  the Authority 
submitted a reasoned opinion on the existing MRLs in accordance with Article  12(1) 
of Regulation (EC) No  396/20056. The Authority proposed changing  the residue 
definition  and lowering the MRLs for  grapefruits, oranges, lemons, limes, mandarins, 
apples, pears, quince s, medlars, loquats/Japanese medlars, apricots, cherries(sweet), 
peaches, plums, table grapes, wine grapes, strawberries, blackberries, raspberries (red 
and yellow), blueberries, currants (black, red and white), gooseberries (green, red 
and yellow), rose h ips, elderberries, table olives, kumquats, potatoes, beetroots, 
carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, 
parsnips, parsley roots/hamburg roots parsley, radishes, salsifies, swedes/rutabagas, 
turnips, garlic, onions, s hallots, sweet peppers/bell peppers, aubergines/eggplants, 
okra/lady's fingers, cucumbers, gherkins, courgettes, melons, pumpkins, 
watermelons, , Brussels sprouts , Chinese cabbages/pe -tsai, kales, kohlrabies, lettuces, 
escaroles/broad -leaved endives, witlo ofs/Belgian endives, chervil, chives, celery 
leaves, parsley, sage, rosemary, thyme, basi l and edible flowers, laurel/Bay leave, 
                                                 
4 European Food Safety Authority; Reasoned opinion on the  review of the existing maximum residue 
levels for fenoxycarb  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2018;16(1):5155 . 
5 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for flurochloridone  according to Article 12 of Regulation (EC ) No 396/2005. EFSA Journal 
2018;16(1):5144. 
6 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for quizalofop -P-ethyl, quizalofop -P-tefuryl and p ropaquizafop  according to Article  12 of 
Regulation (EC) No  396/2005. EFSA Journal 2017;15(1 2):5050 . EN 3  EN tarragon, beans (with pods), beans (without pods), peas (with pods), peas (without 
pods), lentils (fresh), asparagus, celeries,   globe artichokes, leeks, beans (dry), lentils 
(dry), peas (dry), lupins/lupine beans (dry), cotton seeds, olive s for olive oil 
production , herbal infusions from roots and sugar beet roots. For other products, it 
proposed  raisin g or keeping the existing M RLs. It concluded that for tomatoes, head 
cabbages, lamb's lettuces/corn salads, cresses and other sprouts and shoots, land 
cresses, roman rocket/rucola, red mustards, baby leaf crops (including brassica 
species),  spinaches, chards/beet leaves , herbal infusions from flowers, herbal 
infusions from leaves and herbs, seed spices, fruit spices, swine (muscle, fat, liver, 
kidney), bovine (meat, fat, liver, kidney), sheep (meat, fat, liver, kidney), goat (meat, 
fat, liver, kidney), horse (meat, fat, liver, ki dney), 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 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.  
(7) In accordance with Article  6(2) and (4) of Regulation (EC) No  396/2005 an 
application was submitted for quizalofop -P-ethyl  used on maize  in Canada . In 
accordance with Article  8 of Regulation (EC) No  396/2005, this application was 
evaluated by the Member State concerned and t he evaluation report was forwarded to 
the Commission. The Authority assessed the application and the evaluation report, 
examining in particular the risks to the consumer and, where relevant, to animals and 
gave a reasoned opinion on the proposed MRL7. The Authority concluded that all 
requirements with respect to data were met and that the modification requested is 
safe for consumers.  
(8) For tebufenozide the Authority submitted a reasoned opinion on the existing MRLs 
in accordance with Article  12(1) of Regulati on (EC) No  396/20058.  It recommended 
lowering the MRL  for chestnuts . For other products, it proposed  raisin g or keeping 
the existing MRLs . It concluded that for  cherries (sweet), rice, swine (liver, kidney), 
bovine (liver, kidney), sheep (fat, liver, kidney), goat (fat, liver, kidney), horse (liver, 
kidney), poultry (meat, fat, liver), milk (cattle, sheep, goat, horse)  and birds' eggs 
some information was not ava ilable 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 review ed; the review will take into account the 
information available within two years from the publication of this Regulation.  As 
regards broccoli, head cabbage, Chinese cabbage, kale, lamb's lettuces/corn salads, 
lettuces, escaroles/broad -leaved endives, cress es and other sprouts and shoots, land 
cresses, roman rocket/rucola, red mustards, baby leaf crops (including Brassica 
species), spinaches, purslanes, chards/beet leaves, grape leaves and similar species, 
watercresses, chervil, basil  and edible flowers , rap eseeds/canola seeds, sugar  canes , 
swine (meat, fat), bovine (meat, fat), sheep (meat), goat (meat)  and horse (meat, fat)  
the Authority concluded that the Codex maximum residue limit s (CXL) for those 
                                                 
7 European Food Safety Authority; Setting of import tolerance for quizalofop -P-ethyl in genetically 
modified maize. EFSA Journal 2018;16(4)5250.  
8 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for tebufenozide  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2018;16(2):5190 . EN 4  EN products are safe for consumers. It is therefore appropriate to set the MRL s for those 
products at the same level  in Annex  II to Regulation (EC) No  396/2005 . 
(9) As regards products on which the use of the plant protection product concerned is not 
authorised, and for whic h no import tolerances or C XLs 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.  
(10) The Commission consulted the European Union reference laboratories for residue s 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.  
(11) 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.  
(12) Through the World Trad e Organisation, the trading partners of the Union were 
consulted  on the new MRLs and their comments have been taken into account.  
(13) Regulation (EC) No 396/2005 should therefore be amended accordingly.  
(14) In order to allow for the normal marketing, processing an d consumption of products, 
this Regulation should provide for transitional measures  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.  
(15) A reasonab le 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.  
(16) 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  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 Public ations 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.  EN 5  EN Done at Brussels,  
 For the Commission  
 The President  
Jean -Claude JUNCKER