EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11704/2016 Rev. 1  
[…](2016) XXX  draft  
  
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes III and V to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for tricyclazole in or 
on certain products  
(Text with EEA relevance)    
EN 2   EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending  Annexes III and V to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for tricyclazole in or 
on certain products  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on t he 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 17 and  Article 18(1)(b) , 
Whereas:  
(1) For tricyclazole  maximum residue levels (MRLs) were set in Annex II IA to 
Regulation (EC) No 396/2005.  
(2) The non -inclusion of tricylazole  in An nex I  to Directive 91/414/EEC was  provided  for 
in Commission Decision 2008/770/EC2 and the non -approval of this  active substance 
was confirmed  in Commission Implementing Regulation (EU) 2016/18263 following a 
new application in accordance with a rticle 7(1) of R eg. (EC) No 1107/20094. All 
existing authorisations for plant protection products co ntaining this active substance 
have been revoked. The MRLs set out for this substance in Annex III should be 
deleted in accordance with Article 17 of Regulation (EC) No 396 /2005 in conjunction 
with Article 14(1)(a) thereof.  
(3) For those 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.  
(4) The Co mmission consulted the European Union reference laboratories as regards the 
need to adapt certain limits of determination (LODs ). Those laboratories concluded 
that for certain commodities technical development permits the setting of lower LODs.  
                                                 
1 OJ L 70, 16.3.2005, p. 1.  
2 Commission Decision 2008/770/EC  of 30 September 2008  concerning the non -inclusion of tricyclazole  
in Annex I to Council Directive 91/414/EEC and the withdrawal of author isations for plant protection 
products containing that substance (OJ L 263, 02.10.2008, p. 16 ). 
3 Commission Implementing Regulation (EU) 2016/1826 of 14 October 2016 concerning the non -
approval of the active substance tricyclazole, 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  (OJ L 279, 15.10.2016, p. 88 ). 
4 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 
concerning the placing of plant protection products on the market a nd repealing Council 
Directives  79/117/EEC and 91/414/EEC  (OJ L 309, 24.11.2009, p. 1).   
EN 3   EN (5) Through th e World Trade Organisation, the trading partners of the Union were 
consulted on the new MRLs and their comments have been taken into account . 
(6) Regulation (EC) No  396/2005 should therefore be amended accordingly.  
(7) In view of the long shelf life of rice  and pr oducts made of rice , this Regulation should 
provide for a transitional arrangement for rice grown in  2016  or before , in order to 
allow for the normal marketing, processing and consumption of rice and products 
made thereof . However  taking into account  the uncertainties regarding certain 
properties of tricyclazole , the timelines foreseen in this Regulation do not allow for 
any treatment with tricyclazole in 2017  or thereafter . 
(8) Because Basmati rice undergoes a specific procedure of maturation before it c an be 
placed on the market , a reasonable period should be allowed to elapse before the 
modified MRL for Basmati rice becomes 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 th e modification of the MRL.  
(9) 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 I 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 apply to all rice , except B asmati rice , which was  imported or placed on the market 
before [Office of Publications please insert date of entry into force of this Regulation] . 
Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall 
continue apply to Basmati rice which was imported before [Office of Publications please 
insert date 6 months after entry into force of this Regulation] . 
Article 3  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Officia l Journal of the European Union . 
It shall  apply for all products except Basmati rice from [Office of Publications: please insert 
date of entry into force] . 
It shall  apply for Basmati rice from [Office of Publications: please insert date 6 months after 
date of entry into force] .  
EN 4   EN This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER