EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/12558/2019 Rev1  
[…](2020) 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 bupirimate, 
carfentrazone -ethyl, emamectin, ethirimol, and pyriofenone 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 bupirimate, 
carfentrazone -ethyl, emamectin, ethirimol, and pyriofenone 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 particu lar 
Article  14(1)(a)  and Article  49(2) thereof,  
Whereas:  
(1) For carfentrazone -ethyl maximum residue levels (MRLs) were set in Annex  II to 
Regulation (EC) No  396/2005 . For bupirimate, emamectin , ethririmol  and pyriofenone 
MRLs  were set in Part  A of Annex  III to that Regulation.  
(2) For bupirimate  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 proposed two separate residue definition s, “bupirimate” and 
“ethirimol”, in order to cover the presence of the metabolite ethirimol from the use of 
bupirimate  in commodities of plant origin . It proposed to change the residue 
definitions for  commodities of animal origin  into “ desethyl ethirimol” . The Authority  
recommended lowering the MRLs of bupirimate for strawberries, blackberries , 
dewberries, currants (black, red and white), gooseberries (green, red and yellow), 
tomatoes, aubergines/eggplants, sweet peppers/bell peppers, and courgettes.  For 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 existing 
level or the level identified by the Authority. The Authority further concluded t hat 
concerning the MRLs for table and wine grapes , aubergines/eggplants  and products of 
animal origin 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.   
(3) As regards ethirimol, which is the major degradation product of bupirimate, the 
Authority  recommended lowering the MRLs of ethirimol for apples, pears, apricots, 
                                                 
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 bupirimate according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 201 9; 
17(7): 5757 . EN 2  EN peaches, table and wine grapes, blackberries, dewberries, tomatoes, sweet peppers/bell 
peppers, cucumbers, gherkins  and courgettes. For 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 396/200 5 at the existing level or the level identified 
by the Authority. The Authority further  concluded that concerning the MRL s for table 
and wine grapes, aubergines/eggplants  and products of animal origin some 
information was not available and that further con sideration 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; t he review will take into 
account the information available within two years from the publication of this 
Regulation.  
(4) For carfentrazone -ethyl 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.  The Authority confirmed the 
proposal to change the resid ue definition in its peer review4. 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 existing level or the level identified by the 
Authority.  
(5) For emamectin  the Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article  12(1) of Regula tion (EC) No  396/20055. It proposed to 
change the residue definition . It recommended lowering the MRLs for  oranges, 
lemons, mandarins, plums, table and wine grapes, cucumbers, gherkins, courgettes, 
melons, watermelons, broccoli, cauliflowers, Brussels sprouts, head cabbages, lamb’s 
lettuces/ corn salads, lettuces,  cresses and other sprouts and shoots, land cre sses, 
Roman rocket/ rucola, red mustards, baby leaf crops (including brassica species), 
chervil, chives, celery leaves, parsley, sage, rosemary, thyme, basil and edible flowers, 
laurel/bay leave, tarragon, peas (without pods) and globe artichokes.  For othe r 
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. The Authority further  
concluded  that concerning the MRLs for citrus fruits, tree nuts, apricots,  table and 
wine grapes, strawberries, cane fruits, blueberries, cranberries, currants (black, red and 
white), gooseberries, rose hips, mulberries  (black and white) , azaroles/ Mediterranean 
medlars, elderberries, table olives, avocados, pumpkins, escarole/broad -leaved 
endives , oilseeds and oil fruits, swine (muscle, fat tissue, liver, kidney), bovine  
(muscle, fat tissue, liver, kidney), sheep (muscle, fat tissue, liver, kidney), goat 
(muscle, fa t tissue, liver, kidney), equine (muscle, fat tissue, 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 existing level or the level identified by the Authority. These MRLs will be 
                                                 
3 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for carfentrazone -ethyl  according to Article 12 of Regulation (EC) No 396/2005.  EFSA Journal 
2012;10(11):2956 . 
4 European Food Safety Authority; Peer review of the pesticide risk assessment of the  active substance 
carfentrazone -ethyl . EFSA Journal  2016;14(8):4569 . 
5 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for emamectin  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2019;17(8):5803 . EN 3  EN reviewed; the review will take into account the information available within two years 
from the publi cation of this Regulation.   
(6) For pyriofenone the Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article  12(1) of Regulation (EC) No  396/20056. It recommended 
raising or keeping the existing MRLs . The MRLs for those products s hould be set in 
Annex  II to Regulation (EC) No  396/2005 at the existing level or the level identified 
by the Authority.  The Authority further concluded that concerning the MRLs for 
swine (muscle, fat tissue, liver, kidney), bovine (muscle, fat tissue, live r, kidney), 
sheep (muscle, fat tissue, liver, kidney), goat (muscle, fat tissue, liver, kidney), equine 
(muscle, fat tissue, liver, kidney)  and milk (cattle, sheep, goat, horse) some 
information was not available and that further consideration by risk mana gers 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 int o 
account the information available within two years from the publication of this 
Regulation.  
(7) Existing Codex maximum residue limits (CXLs) were taken into account in the 
reasoned opinions of the Authority. CXLs which are safe for consumers in the Union,  
were considered for MRL setting.  
(8) 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 limit of determination (LOD ) or the default MRL should apply, as 
provided for in Article  18(1)(b) of Regulation  (EC) No  396/2005.  
(9) The Commission consulted the European Union reference laboratories for residues of 
pesticides as regards the need to adapt certain LODs . As regards several substa nces, 
those laboratories concluded that for certain commodities technical development 
requires the setting of specific LODs . 
(10) 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.  
(11) Through the World Trade Organisation, the trading partners of the Union were 
consulted on the new MRLs and their comments have been taken into a ccount.  
(12) Regulation (EC) No 396/2005 should therefore be amended accordingly.  
(13) 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 prod uced before the modification of the MRLs and for which information shows 
that a high level of consumer protection is maintained.  
(14) A reasonable period should be allowed to elapse before the modified MRLs become 
applicable in order to permit Member States, th ird countries and food business 
operators to prepare themselves to meet the new requirements which will result from 
the modification of the MRLs.  
(15) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed , 
                                                 
6 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for pyriofenone  according to Article 12 of Regulation (EC ) No 396/2005. EFSA Journal 
2019;17(6):5711 . EN 4  EN 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 t his 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  
Ursula VON DER LEYEN