EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10304/2019 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 chromafenozide, 
fluometuron, pencycuron, sedaxane, tau -fluvalinate and triazoxide 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 chromafenozide, 
fluometuron, pencycuron, sedaxane, tau -fluvalinate and triazoxide 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 chromafenozide , fluometuron , pencycuron, sedaxane and tau -fluvalinate 
maximum residue levels (MRLs) were set in Part A of Annex II I to Regulation (EC) 
No 396/2005. For triazoxide no MRLs were set  in Regulation (EC) No 396/2005  and 
as th is active substance  is not included in Annex  IV to that Regulation, the default 
value of 0,01 mg/kg laid down in Article  18(1)(b) of that Regulation applies.  
(2) For chromafenozide  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  396/20052. No uses are authorised and no 
import tolerances exist for chromafenozide in the Union . The Authority concluded 
that setting the MRL at the limit of determination (LOD) would provide a 
satisfactory level of protection for consumers in the Union . Therefore, MRLs should 
be set in Annex  II to Regulation (EC) No  396/2005 at the specific LOD.   
(3) For fluometuron  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 res idue definition and recommended keeping  the existing MRL  for cotton 
seeds . No oth er authorisations exist for this substance . As there is no risk for 
consumers, the MRL  for that product  should be set in Annex  II to Regulation (EC) 
No 396/2005  at the existing level . 
                                                 
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 chromafenozide  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2019;17(1):5 533. 
3 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for fluometuron  according to Article 12 of Regulation (EC) No 396 /2005. EFSA Journal 
2019;17(1):5560.  
EN 2  EN (4) For pencycuron  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 and concluded that concerning the MRLs for all 
commodities some information was not available and that further consideration by 
risk managers was required. As a risk for consumers cannot be excluded, the 
Authority recommended lowering  the MRLs for plant and animal commodities to the 
relevant LOD .  
(5) For sedaxan e the Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article 12(1) of Regulation (EC) No  396/20055. It proposed to 
change the residue definition  and recommended keeping  the existing MRLs.  As there 
is no risk for consumers, MRLs should be set in Annex  II to Regulation (EC) 
No 396/2005  at the existing level . 
(6) For tau -fluvalinate the Authority submitted a reasoned opinion on the existing MRLs 
in accordance with Article 12(1) of Regulation (EC) No  396/20056. It proposed to 
change the residue definitio n and recommended lowering the MRLs for cherries 
(sweet), strawberries, beetroots, carrots, broccoli, beans (without pods), peas 
(without pods), sesame seeds, rapeseeds/canola seeds, cotton seeds, barley, oat s, 
swine ( muscle, fat , kidn ey), kidney ( bovine, sheep, goat, equine ), milk (cattle, sheep, 
goat, horse). For other products, the Authority recommended raising or keeping the 
existing MRLs . 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.  It concluded  that concerning the MRLs for  
cucumbers and poultry fat  some information was not available and that further 
consideration by risk managers was required. These MRLs will be reviewed; the 
review will take into account the information available within two years from the 
publication of this Regulation.  
(7) For triazox ide the Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article 12(1) of Regulation (EC) No  396/20057. It recommended 
lowering the MRLs for barley, oats, rye and wheat. No other authorisations exist for 
this substance. As the re is no risk for consumers, the MRLs for those products should 
be set at Limit of Determination (LOD) or the level identified by the Authority  in 
Annex  II to Regulation (EC) No  396/2005.   
(8) As regards products on which the use of the plant protection produc t concerned is not 
authorised, and for which no import tolerances or Codex maximum residue limits 
(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.  
                                                 
4 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for pencycuron  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2018;16(12):5518. 
5 European Fo od Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for sedaxan e according to Article 12 of Regulation (EC ) No 396/2005. EFSA Journal 
2019;17(1):5544. 
6 European Food Safety Authority; Reasoned opinion on the review o f the existing maximum residue 
levels for tau-fluvalinate  according to Article 12 of Regulation (EC ) No 396/2005. EFSA Journal 
2018;16(11):5475 . 
7 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for triazoxide  according to Article 12 of Regulation (EC ) No 396/2005. EFSA Journal 
2019;17(1):55 25.  
EN 3  EN (9) The Commission consulted the European Union reference laboratories for residues of 
pesticides as regards the need to adapt certain limits of determination. As regards 
several substances, those laboratories concluded that for certain commodities 
technical devel opment requires the setting of specific limits of determination.  
(10) 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 requiremen ts of Article  14(2) of Regulation (EC) No  396/2005.  
(11) 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.  
(12) Regulation (EC) No 396/2005 should therefore be amended accordingly.  
(13) 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 i nformation 
shows that a high level of consumer protection is maintained.  
(14) 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 the mselves to meet the new requirements which will result from 
the modification of the MRLs.  
(15) 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 REGULATI ON: 
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 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 publi cation 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.   
EN 4  EN Done at Brussels,  
 For the Commission  
The President  
Jean -Claude JUNCKER