EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10044/2020 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 acequinocyl, 
cycloxydim, diclofop, fluopyram, ipconazole and terbuthylazine 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 acequinocyl, 
cycloxydim, diclofop, fluopyram, ipconazole and terbuthylazine 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 pa rticular 
Article  14(1)(a)  and Article  49(2) thereof,  
Whereas:  
(1) For acequinocyl, cycloxydim, diclofop, fluopyram, ipconazole and terbuthylazine 
maximum residue levels (MRLs)  were set in Part A of Annex III to Regulation (EC) 
No 396/2005.  
(2) For acequinocyl  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. For some products, t he 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 grapefruit s, 
oranges, lemons, limes, mandarins, hazelnuts/cobnuts , apples, pears, quinces, medlars, 
loquats/Japanese medlars table and wine grapes, tomatoes, aubergines/eggplants , hops, 
swine ( muscle , fat, liver, kidney), bovine ( muscle , fat, liver, kidney, milk), equine  
(muscle , fat, liver, kidney, milk) 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 exis ting 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) For cycloxydim the Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article 12(1) of Regulation (EC) No 396/20053. The Authority 
                                                 
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 acequinocyl  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 20 20; 
18(1):  5983. 
3 European Food Safety Authority; 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 2  EN recommended lowering the MRLs for apples, pears, apricots, peaches, table and wine 
grapes, celeriacs/turnip rooted celeries , peas (fresh, with pods ), Florence fennels , globe 
artichokes, rapeseeds/canola seeds , sugar beet roots  and poultry (m uscle , fat, liver). 
For other 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 spring onions/green onions 
and Welsh onions , lamb’s lettuces/corn salads , escaroles/broad -leaved endives , 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.  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 publi cation of this 
Regulation.  
(4) For diclofop  the Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article 12(1) of Regulation (EC) No 396/20054. It proposed to 
change the residue definition . The Authority  concluded that concerning the MRLs for 
barley and wheat , 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 Regulatio n (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.  
(5) For fluopyram the Authorit y submitted a reasoned opinion on the existing MRLs in 
accordance with Article  12(1) of Regulation (EC) No  396/20055. It recommended 
lowering the MRLs for  mulberries (black and white) , elderberries, cassava 
roots/manioc , arrowroot s, beetroot s, garlic, onions, shallots, chervil, chives, celer y 
leaves, parsley, sage, rosemary, thyme, laurel/bay leaves , tarragon , lentils , buckwheat 
and other pseudocereals  and herbal infusions from  roots . For other products, the 
Authority recommended raising or keeping the existing MRLs. Based on rotational 
crops studies  and t aking into account that the uptake  of residues  in succeeding crops 
cannot be fully avoided, specific MRLs reflecting upt ake of resid ues from soil were 
derived for cassava roots/manioc, sweet potatoes, yams, arrowroots, other root and 
tuber vegetables except sugar beets , chicory roots , broccoli, cauliflower s, Brussels 
sprouts, head cabbage s, kales, kohlrabies , watercress es, herbal infus ions from roots , 
root and rhizome spices , sugar beet  roots , sweet corn, maize /corn , buckwheat and 
other pseudocereals  and common millet/proso millet . 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 fo r lemons, mandarins, bananas, spring onions/gree n onions and Welsh onions , 
tomatoes, melons, watermelons, Chinese cabbage/pe -tsai, escaroles/broad -leaved 
endives , land cresses, red mustards, spinaches, chards/beet leaves , globe artichokes 
and leeks some information was not available and that further con sideration by risk 
                                                 
4 European Food Safety Authority; Reasoned opinion on the re view of the existing maximum residue 
levels for diclofop according to Article 12 of Regulation (EC) No 396/ 2005. EFSA Journal 2020; 
18(1):  5981. 
5 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for fluopyram  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2020; 
18(4): 6059 . EN 3  EN 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.  
(6) For ipconazole the Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article 12(1) of Regulation (EC) No 396/2 0056. It recommended 
keeping the existing MRLs. The MRLs for th e products  concerned  should be set in 
Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified 
by the Authority . 
(7) For terbuthylazine the Authority submitted a reason ed opinion on the existing MRLs 
in accordance with Article 12(1) of Regulation (EC) No 396/20057. The Authority 
proposed to change the residue definition  for milk . It recommended lowering the 
MRLs for maize/corn  and sorghum . The MRLs for those products sho uld be set in 
Annex II to Regulation (EC) No 396/2005 at  the level identified by the Authority. The 
Authority further concluded that concerning the MRLs for  sweet corn, lupins/lupini 
beans , sunflower seeds, cotton seeds, bovine (muscle, fat, liver, kidney,  milk)  and 
equine (muscle, fat, liver, kidney, milk)  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 Reg ulation (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.  
(8) Existing Codex maximum residue limits (CXLs) were tak en 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  in the EU , 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 re ference laboratories for residues of 
pesticides as regards the need to adapt certain LOD . As regards several substances, 
those laboratories concluded that for certain commodities technical development 
requires the setting of specific  LOD . 
(11) Based on the reas oned 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.  
                                                 
6 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for ipconazole according to Article 12 of Regulation (EC)  No 396/2005. EFSA Journal 2020; 
18(1): 596 1. 
7 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for terbuthylazine according to Article 12 of Regulation (EC) No 396/2005 . EFSA Journal 2020; 
18(1): 5980.  EN 4  EN (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 reaso nable 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 a ccordance 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 Publica tions 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.  
Done at Brussels,  
 For the Commission  
 The President   
 Ursula VON DER LEYEN