EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/11128/2021 Rev1  
[…](2022) 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 1 -methyl -3-
(trifluoromethyl) -1H-pyrazole -4-carboxamide, cycloxydim, cyflumetofen, cyfluthrin, 
metobromuron and pe nthiopyrad 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 1 -methyl -3-
(trifluoromethyl) -1H-pyrazole -4-carboxamide, cycloxydim, cyflumetofen, cyfluthrin, 
metobromuron and penthiopyrad 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 a mending Council Directive 91/414/EEC1, and in particular 
Article  14(1) , point (a) and Article  49(2) thereof,  
Whereas:  
(1) For cyclo xydim, cyflumetofen  and penthiopyrad , maximum residue levels ( ‘MRLs ’) 
are  set in Part A of Annex III to Regulation (EC) No  396/2005. For cyfluthrin MRLs 
are set in  Annexes II and   III to that Regulation. For 1-methyl -3-(trifluoromethyl) -1H-
pyrazole -4-carboxamide (PAM) and metobromuron, no specific MRLs are set in 
Regulat ion (EC) No 396/2005, and as these  active substance s are not included in 
Annex IV to that Regulation, the default value of 0 .01 mg/kg laid down in Article 
18(1), point (b), of that Regulation applies . 
(2)  The European Food Safety Authority (‘the Authority’)  submitted a reasoned opinion 
on the existing MRLs  for beta‐cyfluthrin  and cyfluthrin  in accordance with 
Article  12(1) of Regulation (EC) No  396/20052. In its reasoned opinion the Authority 
confirmed  the residue definition as “ cyfluthrin, including other mixtures of constituent 
isomers (sum of  isomers )”. As b eta-cyfluthrin  is such an isomer of cyfluthrin , MRLs 
established  for cyfluthrin also cover beta -cyfluthrin. Both substances are no longer 
approved as active substances used in plant protection products in the EU.  Therefore,  
the Authority assessed the MRLs  based on non -EU uses  of plant protection products , 
such as those currently  established by the Codex Alimentarius Commission (Codex 
Maximum Residue L imits (CXLs)  and the import tolerances  reported by Member 
States . The Authority also took  into account the authorised use of cyfluthrin in 
veterinary medicinal products for bovine and ovine and the MRLs set in Regulation 
(EU) No 470/20093 The Authority  recommended lowering the MRLs for apples, 
                                                 
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 beta-cyfluthrin and c yfluthrin according to Article 12 of Regulation (EC) No 396/2005. EFSA 
Journal 2021;19(9):6837 . 
3  Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying 
down Community procedures for the establishment of residue limits of pharmacologically active 
substances in foodstuffs of animal origin, repe aling Council Regulation (EEC) No 2377/90 and 
 EN 2  EN pears, potatoes, sweet pep pers/bell peppers , head cabbage s, “fruit spices ”, “root and 
rhizome spices ”, swine (m uscle , liver, kidney), bovine ( muscle  liver, kidney), sheep 
(muscle, liver, kidney), goat (muscle, liver, kidney)  equine (muscle, liver, kidney), 
poultry (muscle, fat, liv er), horse milk and birds’ eggs.  The Authority  also 
recommended  lowering  the MRLs  for grapefruit, oranges, lemons, limes, mandarins , 
tomatoes,  aubergines/eggplants, rapeseeds/canola seeds, cotton seeds.  Further, the 
Authority  recommended keeping th e existing MRLs for  soyabean, fat ( bovine, sheep, 
goat, equine ), milk  (cattle, sheep and goat ) for which sufficient supporting data on 
good agricultural practices were submitted and assessed by the Authority.  As there is 
no risk for consumers , it is appropr iate to set the MRLs for all products  above in 
Annex II to Regulation (EC) No 396/2005 at the existing level or at the level identified 
by the Authority.   
(3) For the use of b eta‐cyfluthrin and cyfluthrin  on cauliflower, the Authority identified a 
possible acute risk for consumers if the CXL for cauliflower was set .  Therefore the 
MRL will be lowered to the default value of 0.01mg/kg .  
(4) The Authority further  concluded that concerning the MRLs for barley and wh eat some 
information was not available and that further consideration by risk managers was 
required. While  these MRLs are considered safe , they will be reviewed; the review 
will take into account the information available within two years from the publicat ion 
of this Regulation. As there is no risk for consumers , it is appropriate to set the MRLs  
for cyfluthrin , for barley and wheat  in Annex II to Regulation (EC) No 396/2005 at the 
level identified by the Authority.  
(5) For cycloxydim , the Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article 12(1) of Regulation (EC) No 396/20054. The Authority 
recommended lowering the MRLs for apples, pears, apricots, peaches, table and wine 
grapes, celeriacs/turnip roo ted celeries , peas (fresh, with pods), Florence fennels , globe 
artichokes, rapeseeds/canola seeds , sugar beet roots  and poultry (m uscle , fat, liver).  It 
recommended raising MRLs for  strawberries, potatoes, sweet potatoes, beetroots, 
horseradishes , parsnips , parsley roots/H amburg roots parsley , radishes, salsifies,  
swedes/rutabagas , turnips, garlic, shallots, broccoli, cauliflowers,  Brussels sprouts, 
head cabbage, kohlrabies, Roman rocket/rucola , red mustards,  Baby leaf crops 
(including brassica species) , spinaches, p urslanes , chards/beet leaves , “herbs and 
edible flowers ”, beans (without pods) , peas (with pods) , lentils , lupins/lupini beans , 
poppy seeds, mustard seeds, cotton seeds, borage seeds, bovine (muscle, fat , kidney ), 
sheep (muscle, fat, kidney),  goat (muscle, fat, kidney),  equine (muscle, fat, kidney),  
milk (cattle, sheep, goat, horse) and bird’s eggs.  It recommended keeping those 
existing MRLs for other products for which sufficient supporting data on good 
agricultural practices were submitte d and assessed by the Authority . As there is no risk 
for consumers, it is appropriate to set the MRLs for all products  above  in Annex II to 
Regulation (EC) No  396/2005 at the existing level or the level identified by the 
Authority .  
(6) The Authority  further  concl uded that concerning the MRLs for spring onions/green 
onions and Welsh onions , lamb’s lettuces/corn salads , escaroles/broad -leaved endives , 
                                                                                                                                                         
amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) 
No 726/2004 of the European Parliament and of the Council . OJ L 152, 16.06 .2009, p. 1 1. 
4 European Food Safety Aut hority; Reasoned opinion on the review of the existing maximum residue 
levels for cycloxydim according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2020; 
18(1): 59 62. EN 3  EN cresses and other sprouts and shoots, land cresses, maize/corn and herbal infusions 
from roots , some information was  not available and that further consideration by risk 
managers was required.  While these MRLs are considered safe, they will be reviewed; 
the review will take into account the information available within two years from the 
publication of this Regulation. As there is no risk for consumers, it is appropriate to set 
the MRLs for cycloxydim , for all products above in Annex II to Regulation (EC) No 
396/2005 at the level identified by the Authority.  
(7) For cyflumetofen , the Authority submitted a reasoned opinion on  the existing MRLs in 
accordance with Article 12(1) of Regulation (EC) No 396/20055. It recommended 
keeping th e existing MRLs for strawberries, a zaroles/Mediterranean medlars , 
kaki/Japanese persimmons , tomatoes, aubergines/eggplants, c ucumbers  and hops  for 
which sufficient supporting data on good agricultural practices were submitted and 
assessed by the Authority . As there is no risk for consumers , it is appropriate to set the 
MRLs for those products in Annex II to Regulation (EC) No 396/2005 at the leve l 
identified by the Authority.  
(8) The Authority further concluded that concerning the MRLs for swine (muscle, fat, 
liver kidney), bovine (muscle, fat, liver kidney), sheep (muscle, fat, liver kidney), goat 
(muscle, fat, liver kidney), equine (muscle, fat, li ver kidney), and milk (cattle, sheep,  
goat, horse)  some information was not available and that further consideration by risk 
managers was required. While these MRLs are considered safe, they will be reviewed; 
the review will take into account the informati on available within two years from the 
publication of this Regulation. As there is no risk for consumers,  it is appropriate to set  
the MRLs for  cyflumetofen  for all products above in Annex II to Regulation (EC) No 
396/2005 at the level identified by the Au thority.   
(9) For metobromuron , the Authority submitted a reasoned opinion on the existing MRLs 
in accordance with Article  12(1) of Regulation (EC) No  396/20056. It proposed to 
change the residue definition  to the sum of metobromuron and 4 -bromophenylurea, 
expressed as metobromuron .  
(10) The Authority concluded that concerning the MRLs for  strawberries, potatoes, carrots, 
parsnips, lamb's lettuces/corn salads , spinaches, watercresses, celery leaves, parsley, 
sage, thyme, b asil and edible flowers , beans (with pod s), beans (without pods) , 
asparagus, Florence fennels, beans, peas, sunflower seeds, soyabeans, swine (muscle, 
fat, liver kidney), 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.  While these MRLs are considered safe  for consumers , 
they will be reviewed; the review will take into acco unt the information available 
within two years from the publication of this Regulation. As there is no risk for 
consumers,  it is appropriate to set  the MRLs  for metobromuron , for all products above 
in Annex II to Regulation (EC) No 396/2005 at the level id entified by the Authority.   
                                                 
5 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for cyflumetofen  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2021;19(8):6812 . 
6 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for metobromuron  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2021;19(9):6841 . EN 4  EN (11) For penthiopyrad , the Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article 12(1) of Regulation (EC) No 396/20057. For products of  
animal origin , it proposed two separate residue definitions, ‘penthiopyrad’ and ‘1 -
methyl -3-(trifluoromethyl) -1H-pyrazole -4-carboxamide (PAM)’, in order to cover the 
presence of the metabolite 1 -methyl -3-(trifluoromethyl) -1H-pyrazole -4-carboxamide 
(PAM) from the use of pe nthiopyrad in products  of animal origin. The Authority 
recommended lowering the MRLs for  apricots, peaches and oats.  It recommended 
raising MRLs for  rye and wheat. It recommended keeping the existing MRLs for other 
products for which sufficient supporting data on good agricultural practices were 
submitte d and assessed by the Authority. As there is no risk for consumers , it is 
appropriate to set  the MRLs for those products in Annex II to Regulation (EC) No 
396/2005 at the existing level or the level identifi ed by the Authority.  
(12) The Authority further concluded that concerning the MRLs for spring onio ns/green 
onions and Welsh onions, l amb's lettuces/corn salads , lettuces, cresses and other 
sprouts and shoots, land cresses, Roman rocket/rucola, red mustards, sp inaches , 
purslanes, c hards/beet leaves , chervil, chives, cardoons, celeries, Florence fennels, 
leeks, rhubarbs, cotton seeds, barley and sorghum some information was not available 
and that further consideration by risk managers was required. While these MRLs are 
considered safe, they will be reviewed; the review will take into account the 
information available within two years from the publication of this Regulation. As 
there is no risk for consumers, it is appropriate to set the MRLs for  penthiopyrad , for 
all products above in Annex II to Regulation (EC) No 396/2005 at the level identified 
by the Authority.  
(13) As regards 1 -methyl -3-(trifluoromethyl) -1H-pyrazole -4-carboxamide (PAM), which is 
a main metabolite of penthiopyrad , the Authority  recomme nded , based on the 
metabolism studies of penthiopyrad in livestock, setting MRLs at the limit of 
determination (‘LOD’) in products  of animal  origin. With regard to products  of plant 
origin, the Authority d id not propose any MRLs  because  this metabolite is not relevant 
for products  of plant origin . Furthermore, in products of plant origin  1-methyl -3-
(trifluoromethyl) -1H-pyrazole -4-carboxamide  (PAM)  may occur naturall y and setting 
an MRL at  the default value of 0.01 mg/kg is not appropriate. It is therefore  
appropriate to  clarif y in Annex II that the default value of 0.01 mg/kg for  1-methyl -3-
(trifluoromethyl) -1H-pyrazole -4-carboxamide  (PAM ) does not apply to products  of 
plant origin . As there is no risk for consumers,  it is appropriate to set the MRLs in 
Annex II to Regulation (EC) No 396/2005  at the level identified by the Authority . The 
Authority assessed the existing CXLs in its reasoned opinions. For setting the MR Ls, 
the Commission has taken into account those CXLs that are considered safe for 
consume rs in the Union.   
(14) As regards products on which the use of the plant protection product concerned is not 
authorised  in the Union , and for which no import tolerances or CXLs exist, MRLs 
should be set at the LOD  or for the default value of 0.01mg/kg  to apply, as provided 
for in Article  18(1) , point (b), of Regulation  (EC) No  396/2005.  
(15) The Commission consulted the European Union reference laboratories for residues of 
pesticides as regards the need to adapt certain LOD . For all the active substances 
                                                 
7 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for penthiopyrad  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2021;  
19(9):6810 . EN 5  EN covere d by this Regulation those laboratories proposed product specific LODs that are 
analytically achievable.  
(16) 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.  
Regulation (EC) No 396/2005 should therefore be amended accordingly.  
(17) For 1-methyl -3-(trifluoromethyl) -1H-pyrazole -4-carboxamide, cycloxydim, 
cyflumetofen, cyfluthrin, metobromuron and penthiopyrad , to allow for the normal 
marketing, processing and consump tion of products, this Regulation should not apply  
to products which have been produced in the Union or imported into the Union before 
the modifi ed MRLs  become applicable  and for which information shows that a high 
level of consumer protection is maintained.   
(18) 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 
operat ors to adapt  themselves to meet the requirements which result from the 
modification of the MRLs.  
(19) 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 R EGULATION:  
Article 1  
Annexes II  and III to Regulation (EC) No 396/2005 are amended in accordance with the 
Annex to this Regulation.  
Article 2  
As regards  1-methyl -3-(trifluoromethyl) -1H-pyrazole -4-carboxamide, cycloxydim, 
cyflumetofen, cyfluthrin, metobromuron and penthiopyrad  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 Union or imported into the Union before … [Office of 
Publica tion: please insert date 6 months after entry into force] . 
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.  
Done at Brussels,  
 For the Commission  
 The President   
 Ursula VON DER LEYEN