EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/12030/2020  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 6 -benzyladenine, 
aminopyralid and chlorantraniliprole 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 6 -benzyladenine, 
aminopyralid and chlorantraniliprole 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 Reg ulation (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 aminopyralid and chlorantraniliprole , maximum residue levels (MRLs)  were set in 
Part A of Annex III to Regulation (EC) No  396/2005. For 6-benzyladenine , no MRLs 
were  set in Regulation (EC) No  396/2005, and as that 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 6-benzyladenine , 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 MRLs at the limit of 
determination (‘LOD’). Those MRLs should be set in Annex II to Regulation (EC) No 
396/2005 .  
(3) For aminopyrali d, the Authority  submitted a reasoned opinion on the existing MRLs in 
accordance with Article  12(1) of Regulation (EC) No  396/20053. It proposed to 
change the residue definition  for commodities of plant origin . It recommended 
lowering the MRLs for poultry fat. 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.  
                                                 
1 OJ L 070, 16.3.2005 , p. 1.  
2 European Food Safety Authority; Reasoned opinion on the review of the existing maxim um residue 
levels for 6-benzyladenine  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2020; 18( 7): 6220 . 
3 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for aminopyralid  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 20 20; 
18(8): 6229 . EN 2  EN (4) For chlorantraniliprole,  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 for  almonds, Brazil nuts, cashew nuts,  chestnuts, 
coconuts, hazelnuts/cobnuts, macadamias, p ecans, pine nut kernels, pistachios, 
walnuts, apples, pears, quinces, medlars, l oquats/Japanese medlars , sweet corn, 
cauliflowers, celer ies, coffee beans and muscle  (swine, bovine, sheep, goat  and 
equine) . 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 sweet peppers/bell peppers , melons, 
watermelons , grape leaves and similar species , peanuts/groundnuts , sunflower seeds  
and rapeseeds/canola seeds  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 a vailable within two years 
from the  publication of this Regulation.  
(5) 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 sett ing. 
(6) 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 LOD or the default MRL should apply, as provided for in Article  18(1)(b) 
of Regulation  (EC) No  396/2005.  
(7) The Commission consulted the European Union reference laboratories for residues of 
pesticides as regards the need to adapt certain LODs . As regards several  substances 
concerned by this Regulation , those laboratories  concluded that for certain 
commodities technical development requires the setting of specific LODs . 
(8) Based on the reasoned opinions of the Authority and taking into account the factors 
relevant to the matter under consideration, the appropriate modificatio ns to the MRLs 
fulfil the requirements of Article  14(2) of Regulation (EC) No  396/2005.  
(9) 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.  
(10) Regulation (EC) No 396/2005 should therefore be amended accordingly.  
(11) 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 modifica tion of the MRLs and for which information shows 
that a high level of consumer protection is maintained.  
(12) A reasonable period should be allowed to elapse before the modified MRLs become 
applicable in order to permit Member States, third countries and food b usiness 
operators to prepare themselves to meet the new requirements which will result from 
the modification of the MRLs.  
                                                 
4 European Food Safety Authority; Reasoned opinio n on the review of the existing maximum residue 
levels for chlorantraniliprole  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2020; 18( 9): 6235 . EN 3  EN (13) 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 Publication : 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 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