EN   EN 
 
 
   
Brussels, XXX  
SANTE/10706/2020 CIS 
(POOL/E4/2020/10706/10706 -EN 
CIS.docx) Rev3  
[…](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 ametoctradin, 
bixafen, fenazaquin, spinetoram, tefluthrin and thiencarbazone -methyl in or on certain 
products  
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission.  
Any views expressed are the preliminary views of the Commission services  
and may not in any circumstances be regarded as stating an official position  
of the C ommission. The information transmitted is intended only for the  
Member State or entity to which it is addressed for discussions and may  
contain confidential and/or privileged material.    
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 ametoctradin, 
bixafen, fenazaquin, spinetoram, tefluthrin and thiencarbazone -methyl in or on certain 
products  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the Europe an 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)  and Article  49(2) thereof,  
Whereas:  
(1) For ametoctradin, bixafen, fenazaquin, spinetoram and tefluthrin  maximum residue 
levels (MRLs)  were set in Part A of Annex III to Regulation (EC) No  396/2005. For 
thiencarbazone -methyl  no MRLs were  set in Regulation (EC) No  396/2005, and as 
this active substance  is 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 ametoctradin  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 lowering the MRLs for peppers. 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 that concerning the MRLs for spring onions/gree n onions and Welsh 
onions , barley, oat, rye, wheat, hops, swine (mea t, fat, liver, kidney), bovine ( meat, 
fat, liver, kidney, milk) , sheep (meat, fat, liver, kidney, milk), goat ( meat, fat, liver, 
kidney, milk ), equine  (meat, fat, liver, kidney, milk) , pou ltry (meat, fat, liver, kidney ) 
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 information available within two years from the 
publication of this Regulation.  
                                                 
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 ametoctradin  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 20 20; 
18(1): 5990.  
EN 2  EN (3) For bixafen the Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article 12(1) of Regulation (EC) No 396/20053. It recommended 
lowering the MRLs  for linseeds, mustard seeds, barley and oat . For other products, it 
recommended raising or keeping the existing MRLs . Based on rotational crops 
studies and taking into account that the uptake of residues in succeeding crops cannot 
be fully avoided, specific MRLs reflecting uptake of residues from soil were derived 
for beetroots, carrots, celeriac/turnip rooted celeries, horseradishes, Jerusalem 
artichokes, parsnips, parsley root/Hamburg roots parsley, radishes, salsifies, 
swedes/rutabagas, turnips, herbal infusions from roots, sugar beet roots and chicory 
roots.  The MRLs for those products should be set in Annex II to Reg ulation (EC) No 
396/2005 at the existing level or the level identified by the Authority .  
(4) For fenazaquin  the Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article 12(1) of Regulation (EC) No 396/20054. It recommended 
loweri ng the MRLs for  cucumbers , melons  and watermelons . For other products, it 
recommended raising or keeping the existing MRLs. The Authority  further 
concluded that concerning the MRLs for citrus fruits, pome fruits, strawberries, 
tomatoes and tea 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 identifie d 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 spinetoram the Authority submitted a reasoned opinion on the existing MRLs in 
accorda nce with Article  12(1) of Regulation (EC) No  396/20055. MRLs . It proposed 
to change the residue definition.  It recommended lowering the MRLs for oranges,  
mandarins, plums, l itchis/lychees , mangoes, potatoes, onions, tomatoes, s weet 
peppers/bell  peppers , aubergines/eggplants , cucumbers, gherkins, courgettes, melons, 
pumpkins, watermelons, sweet corn, broccoli, cauliflower, Brussels sprouts, head 
cabbage, lettuces, spinaches, beans (with pods), leeks and sugar beet roots.  For other 
products, it recommended r aising 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. Taking into account additional 
information on the good agricultural pr actice provided by Belgium and as there is no 
risk for consumers, the MRL for cresses and other sprouts and shoots and land 
cresses should be set in Annex II to Regulation (EC) No 396/2005 at the existing 
level . The Authority further concluded that concern ing the MRLs fo r tree nuts,  pome 
fruits, apricots, table and wine grapes, blackberries, dewberries, cranberries,  
gooseberries (green, red and yellow) , rose hips, mulberries (black and white), 
azaroles/Mediterranean medlars, elderberries,  table olives, soyabeans , cotton seeds,  
olives for oil production , maize/corn , rice,  bovine (fat, liver, kidney), equine (fat, 
liver, kidney), poultry (fat, liver) and birds’ egg  some information was not available 
                                                 
3 European Food Safety Authority; Reasoned opinio n on the review of the existing maxim um residue 
levels for bixafen  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2020; 18(1): 
5998. 
4 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for fenazaquin  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2020; 
18(1): 59 55. 
5 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for spinetoram according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2020; 
18(3): 5997 .  
EN 3  EN 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 inf ormation available 
within two years from the publication of this Regulation.  
(6) For tefluthrin  the Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article 12 (1) of Regulation (EC) No 396/20056. It recommended 
lowering the MRLs for witloofs/Belgian endives  and chicory roots.  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 that 
concerning the MRLs for  celeriacs/turnip rooted celeries , radishes, s wedes/rutabagas , 
turnips, tomatoes , aubergines/eggplants , melons, watermelons,  sweet corn,  lamb's 
lettuces/corn salads , cresses and other sprouts and shoots , land cresses , roman 
rocket/rucola , red mustards, b aby leaf crops (including brassica species) , celeries, 
Florence fennels,  rhubarbs, sunflower seeds, r apeseeds/canola seeds , soyabeans, 
cotton seeds, barley, maize/corn , common millet/proso millet , oat, rye, sorghum, 
wheat , poultry (muscle, fat, liver , kidney , edible offals ) 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 information available wi thin two years from the publication of this 
Regulation.  
(7) For thiencarbazone -methyl  the Authority submitted a reasoned opinion on the 
existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/20057. It 
recommended keeping the existing MRLs . The MRLs for th e products should be set 
in Annex II to Regulation (EC) No  396/2005 at the existing level.  
(8) 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.  
(9) 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.  
(10) The Commission consulted the European Union reference laboratories for residues of 
pesticides as regards the need to adapt certain limits of determinatio n. As regards 
several  substances concerned by this Regulation , those laboratories concluded that 
for certain commodities technical development requires the setting of specific limits 
of determination.  
                                                 
6 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for tefluthrin  according to Article 12 of Regulation (EC) No 396 /2005. EFSA Journal 2020; 
18(1): 59 95. 
7 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for thiencarbazone -methyl according to Article 12 of Regulation (EC) No 396/2005 . EFSA 
Journal 2020; 18(1): 59 57.  
EN 4  EN (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 Trade 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 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 information 
shows that a high level of consumer protection is maintained.  
(15) 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 to meet the new requirements which will result from 
the modification of the MRLs.  
(16) The measures provided for in th is 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 Regulati on. 
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 o f 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.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der LEYEN