EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10909/2018 Rev. 1  
[…](2019) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II, III and V to Regulation (EC) No  396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for amitrole, fipronil, 
flufenoxuron, flupyrsulfuron -methyl, imazosulfuron, isoproturon, orthosulfamuron and 
trias ulfuron in or on certain products  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II, III and V to Regulation (EC) No  396/2005 of the European 
Parliament and of the Council  as regards maximum residue levels for amitrole, fipronil, 
flufenoxuron, flupyrsulfuron -methyl, imazosulfuron, isoproturon, orthosulfamuron and 
triasulfuron in or on certain products  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the T reaty 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 particular 
Article 14(1)(a), Article 18(1)(b) and Article 49(2) thereof,  
Whereas:  
(1) For amitrole, fipronil, flupyrsulfuron -methyl, imazosulfuron, isoproturon and 
triasulfuron, maximum residue levels (MRLs) were set in Annex  II to Regulation (EC) 
No 396/2005. For  flufenoxuron and orthosulfamuron , MRLs were set in Part  A of 
Annex  III to that Regulation . 
(2) The approval of the active substance amitrole was not renewed by Commission 
Implementing Regulation (EU) 2016/8712. The approval of the active substance 
fipronil expired on 30  September  20173. The active substance flufenoxuron was not 
approved by Commission Implementing Regulation (EU) No 942/20114. The approval 
of the active substance flupyrsulfuron -methyl was not renewed by Commission 
Implementing Regulation (EU) 2017/14965. The approval of the active substance 
                                                 
1 OJ L 70, 16.3.2005, p. 1.  
2 Commission Implementing Regulation (EU) 2016/871 of 1 June 2016 concerning the non -renewal of 
approval of the active substance amitrole, in accordance with Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council concerning the placing of plant protection products on the 
market, and amending Commission Implementing Regulation (EU) No 540/2011  (OJ L 145,  2.6.2016, 
p. 4). 
3 Commission Implementing Regulation (EU) 2016/2035 of 21 November 2016 amending Implementing 
Regulation (EU) No 540/2011 as regards the approval periods of the active substances fipronil and 
maneb ( OJ L 314, 22.11.2016, p. 7 ). 
4 Commission Implementing Regulation (EU) No 942/2011 of 22 September 2011 concerning the non -
approval of the active substance flufenoxuron, in accordance with Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council concerning the placing of plant protection products on the 
market, and amending Commission Decision 2008/934/EC  (OJ L 246, 23.9.2011, p.  13). 
5 Commission Implementing Regulation (EU) 2017/1496 of 23 August 2017 concerning the non -renewal 
of approval of the active substance DPX KE 459 (flupyrsulfuron -methyl), in accordance with 
Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing 
of plant protection products on the market, and amending Commission Implementing Regulation (EU) 
No 540/201 1 (OJ L 218, 24.8.2017, p.  7). EN 2  EN imazosulfuron expired on 31  July 20176. The approval of the active substance 
isoproturon was not renewed by Commission Implementing Regulation 
(EU)  2016/8727. The active substance orthosulfamuron was not approved by 
Commission Implementing Regulation (EU) 2017/8408. The approval of the active 
substance triasulfuron was not renewed by Commission Implementing Regulation 
(EU)  2016/8649.  
(3) All existing authorisati ons for plant protection products containing th ose active 
substances have been revoked. It is therefore appropriate to delete the MRLs set out 
for these substances in Annexes II and III of Regulation (EC) No 396/2005 in 
accordance with Article 17 of Regula tion (EC) No 396/2005 in conjunction with 
Article  14(1)(a) thereof, except for the MRL for flufenoxuron in tea , which  is safe to 
consumers10 and corresponds to an import tolerance request from Japan . 
(4) In view of the non-renewal of approval of the active subs tances amitrole, 
flupyrsulfuron -methyl, isoproturon and triasulfuron, the expiry of the approval of the 
active substances fipronil and imazosulfuron , and the non -approval  of the active 
substance s flufenoxuron and  orthosulfamuron , the MRLs for these substan ces should 
be set at the relevant limit of determination (LOD) in accordance with Article  18 of 
Regulation (EC) No  396/2005, except for the MRL for flufenoxuron in tea . 
(5) The Commission consulted the European Union reference laboratories as regards the 
need to adapt certain LODs. Those laboratories concluded that for certain products  
technical development permits the setting of lower LODs. For the active substances 
for which all MRLs should be reduced to the relevant LOD, default values should be 
listed in Annex  V in accordance with Article  18(1)(b) of Regulation (EC) 
No 396/2005.  
(6) 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.  
(7) Regulation (EC) No  396/2005 should therefore be amended accordingly.  
                                                 
6 Commission Implementing Regulation (EU) No  1197/2012 of 13  December 2012 amending 
Implementing Regulation (EU) No  540/2011 as regards the extension of the approval periods of the 
active substances acetamiprid, alpha -cyperme thrin, Ampelomyces quisqualis Strain: AQ 10, benalaxyl, 
bifenazate, bromoxynil, chlorpropham, desmedipham, etoxazole, Gliocladium catenulatum Strain: 
J1446, imazosulfuron, laminarin, mepanipyrim, methoxyfenozide, milbemectin, phenmedipham, 
Pseudomonas chlo roraphis Strain: MA 342, quinoxyfen, S -metolachlor, tepraloxydim, thiacloprid, 
thiram and ziram ( OJ L 342, 14.12.2012, p. 27 ). 
7 Commission Implementing Regulation (EU) 2016/872 of 1 June 2016 concerning the non -renewal of 
approval of the active substance isoproturon, in accordance with Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council concerning the placing of plant protection products on the 
market, and amending Commission Implementing Regulation (EU) No 540/2011  (OJ L 145, 2.6.20 16, 
p. 7). 
8 Commission Implementing Regulation (EU) 2017/840 of 17 May 2017 concerning the non -approval of 
the active substance orthosulfamuron, in accordance with Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council concerning the p lacing of plant protection products on the 
market  (OJ L 125, 18.5.2017, p.  10). 
9 Commission Implementing Regulation (EU) 2016/864 of 31 May 2016 concerning the non -renewal of 
approval of the active substance triasulfuron, in accordance with Regulation (EC ) No 1107/2009 of the 
European Parliament and of the Council concerning the placing of plant protection products on the 
market, and amending Commission Implementing Regulation (EU) No 540/2011  (OJ L 144, 1.6.2016, 
p. 32). 
10 Reasoned opinion on the m odifica tion of the existing MRL for flufenoxuron in tea (dried leaves and 
stalks, fermented of Camellia sinensis) . EFSA Scientific Report (2009) ; 267. EN 3  EN (8) In order to allow for the normal marketing, processing and consumption of products, 
this Regulation should provide for a transitional measure 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.  
(9) 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 
operato rs to prepare themselves to meet the new requirements which will result from 
the modification of the MRLs.  
(10) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOP TED THIS REGULATION:  
Article 1  
Annexes II, III and V 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 app ly to products which were produced in the Union or imported  into the Union 
before [ Office of P ublication: 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 publ ication 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 B russels,  
 For the Commission  
The President  
Jean -Claude JUNCKER