EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10633/2017 Rev. 2  
[…](2018) 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 penoxsulam, 
triflumizole and triflumuron 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 penoxsulam, 
triflumizole and triflumuron 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 particular 
Article 14(1)(a) and Article 49(2) thereof,  
Whereas:  
(1) For penoxsulam, triflumizole and triflunuron , maximum residue levels (MRLs) wer e 
set in Part B of Annex III to Regulation (EC) No 396/2005 .  
(2) For penoxsulam , the European Food Safety Authority  ("the Authority" ) submitted a 
reasoned opinion on the review of the existing MRLs in accordance with Article  12(1) 
of Regulation (EC) No 396/20 052. It recommended keeping the existing MRLs.  Those 
MRLs  should be set in Annex  II to Regulation (EC) N o 396/2005 at the existing levels  
(3) For triflumizole , 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 and concluded that concerning the MRLs of tomato, 
aubergines/eggplant, cucumber, gherkin, courgettes some information was not 
available and that further consideration by risk manage rs 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. The 
Authority concluded that concerning the MRLs for cherries, table grapes, wine grapes, 
papaya and hops no or insufficient information was available and that furt her 
consideration by risk managers was required. The MRLs for these products should be 
set at the specific limit of determination.  
                                                 
1 OJ L 70, 16.3.2005, p. 1.  
2 European Food Safety Authority , 2017. Reasoned opinion on the review of the existing maximum 
residue levels for penoxsulam  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2017;15(4 ):4753. 
3 European Food Safety Authority , 2017.  Reasoned opinion on the review of the existing maximum 
residue levels for triflumizole according to Article 12 of Regulation (EC)  No 396/2005. EFSA Journal 
2017;15(3):4749. EN 2  EN (4) For triflumuron , the Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article 12(1) of Regulati on (EC) No 396/20054. It concluded that 
concerning the MRLs for apricots and plums 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.  
(5) As regards products on which the use of the plant protection product concerned is not 
authorised, and for which no import tolerances or Codex maximum residue limits 
exist, MRLs should be set at the specific limit of determination or the default MRL 
should a pply, as provided for in Article  18(1)(b) of Regulation (EC) No  396/2005.  
(6) The Commission consulted the European Union reference laboratories for residues of 
pesticides as regards the need to adapt certain limits of determination. As regards all 
the three s ubstances , those laboratories concluded that for certain commodities 
technical development requires the setting of specific limits of determination.  
(7) 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.  
(8) Through the World Trade Organisation, the trading partners of the Union were 
consulted on the new MRLs and their comment s have been taken into account.  
(9) Regulation (EC) No  396/2005 should therefore be amended accordingly.  
(10) In order to allow for the normal marketing, processing and consumption of products, 
this Regulation should provide for a transitional arrangement for produ cts which have 
been produced before the modification of the MRLs and for which information shows 
that a high level of consumer protection is maintained.  
(11) 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.  
(12) The measures provided for in this Regulation are in accordance with the opinion of th e 
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 produced or imported into the Union before [Office of 
Publications please insert date of application of this Regulation ]. 
                                                 
4 European Food Safety Authority , 2017. Reasoned opinion on the review of the existing maximum 
residue levels for triflumuron  according to Article 12 of Regulation  (EC) No 396/2005. EFSA 
Journal  2017;15(4 ):4769. EN 3  EN Article 3  
This Regulation shall enter into force on the tw entieth 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 app licable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER