EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10776/2021 Rev. 2  
[…](2021) 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 
1,4-dimethylnaphthalene, 8 -hydroxyquinoline, pinoxaden and valifenalate 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 
1,4-dimethylnaphthalene, 8 -hydroxyquinoline, pinoxaden and valifenalate 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 part icular 
Article 14(1)(a)  and Article 49(2) thereof,   
Whereas:  
(1) For 1,4-dimethylnaphthalene , 8-hydroxyquinoline, pinoxaden  and valifenalate , 
maximum residue levels (MRLs) were set in Part A of Annex III to Regulation (EC) 
No 396/2005.  
(2) For 1,4-dimethylnaphthalene  the European Food Safety Authority ("the Authority"), 
submitted a reasoned opinion on the existing MRLs to the Commission and the 
Member States in accordance with Article  12(1) of Regulation (EC) No  396/20052. 
The Authority  proposed  to change the residue definition for products  of animal 
origin . The Authority considered that, as 1,4 -dimethylnaphthalene could naturally 
occur in plant products , setting MRLs for products  of plant origin  at the Limit of 
Determination (LOD)  could  be inappropriate . It concluded that sufficient monitoring 
data for plant products (except potatoes) and some information on potatoes and 
products of animal origin were  not available , and that further consideration by risk 
managers was required . As there is no  risk for consumers, all MRLs should be set in 
Annex  II to Regulation (EC) No  396/2005 . MRLs for products of plant origin (with 
the exception of potatoes) should be set b ased on currently available monitoring data . 
MRLs for potatoes and products of animal origin should be set at the level s identified 
by the Authority.  All above -mentioned  MRLs will be reviewed; the review will take 
into account the information available within two years from the publication of this 
Regulation.  
(3) For 8-hydroxyquinoline  the Authority submitted a reasoned opinion on the existing 
MRLs to the Commission and the Member States in accordance with Article  12(1) of 
                                                 
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 1,4 -dimethylnaphthalene according to Article 12 of Regulation (EC) No 396/2005. EFSA 
Journal 2021;19(5):6597 .  
EN 2  EN Regulation (EC) No  396/20053. The Authority concluded that , due to missing data , 
the consumer risk assessment performed  is indicative  and therefore proposed setting 
or maintaining  all MRLs at the LOD . As there is no risk for consumers, MRLs 
should be set in Annex  II to Regulation (EC) No  396/2005 . 
(4) For pinoxaden  the Authority submitted a reasoned opinion on the existing MRLs to 
the Commission and the Member States in accordance with Article 12(1) of 
Regulation (EC) No  396/20054. It proposed to change the residue definition. It 
recommended lowering  the MRL s for barley, rye , and wheat . The Authority 
concluded that concerning the MRLs for products of animal origin , some information 
was not available and that further consideration by risk managers was required . The 
MRLs for products of animal origin  will be reviewed ; the review will take into 
account the information available within two years from the publication of this 
Regulation. As there is no risk for consumers, MRLs should be set in Annex II to 
Regulation (EC) No 396/2005 at the existing level or the level iden tified by the 
Authority.  
(5) For valifenalate  the Authority submitted a reasoned opinion on the existing MRLs to 
the Commission and the Member States in accordance with Article  12(1) of 
Regulation (EC) No 396/20055. It proposed to change the residue definition for 
products  of animal origin. It recommended lowering MRLs for onions, shallots , and 
aubergines/eggplants . For other products, it recommended raising  or keeping the 
existing MRLs. Concerning the MRL for tomatoe s, the Authority concluded that 
some information was not available and that further consideration by risk managers 
was required . The MRL for tomatoes will be reviewed . The review  will take into 
account the information available within  two years from the pu blication of this 
Regulation. As there is no risk for consumers , this MRL  should be set in Annex II to 
Regulation (EC) No 396/2005 at the existing level or the level identified by the 
Authority.  
(6) 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 
(CXLs) exist, MRLs should be set at the specific LOD or the default MRL should 
apply, as pr ovided 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. For all the substances covered 
by this Regulation , those  laboratories proposed product specific LO Ds that are 
analytically achievable.  
(8) The modifications of the MRLs proposed by this Regulation are b ased on the 
reasoned opinions of the Authority and  take into account th ose factors listed in 
Article 14(2) of Regulation (EC) No 396/2005 that are relevant to  each substance 
covered by this Regulation.  
                                                 
3 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for 8-hydroxyquinoline according to Article 12 of Regulation (EC ) No 396/2005. EFSA Journal 
2021;19(4):6566 . 
4 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for pinoxad en according to Article 12 of Regulation (EC ) No 396/2005. EFSA Journal 
2021;19 (3):6503. 
5 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for valifenalate  according to Article 12 of Regulation (EC ) No 396/2005. EFSA Journal 
2021;19(5):6591 .  
EN 3  EN (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  transit ory provisions  for products which have 
been pr oduced before the modification 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 business 
operators to prepare themselves to meet the new requirements which will result from 
the modification of the MRLs.  
(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 shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
The President  
Ursula VON DER LEYEN