EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/1782 v3  
[…](2023) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of 
the Council as regards maximum residue levels for dithianon in or on certain products  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of 
the Council as regards maximum residue levels for dithianon 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) , point (a), thereof,   
Whereas:  
(1) The maximum residue levels ( ‘MRLs ’) for dithianon  are set out in Part A of  Annex I II 
to Regulation (EC) No  396/2005.  
(2) The Authority has submitted a reasoned opinion on the review of the existing MRLs  
for dithianon  in accordance with Article 12(1) of Regulation (EC) No 396/20052. The 
Authority noted that the mutagenicity potential of the metabolite 1,4 -naphthoquinone  
remains uncertain , pending the submission of additional studies fulfilling the 
previously identifie d data gap3. Therefore, the values of the acceptable daily intake 
(ADI) and acute reference dose (ARfD) of 1,4-naphthoquinone are considered 
provisional and all MRLs for dithianon  above the limits of determination (LODs) 
require  further consideration by r isk managers.  As the missing data is to be  submitted 
as part of the ongoing procedure for the renewal of the approval of dithianon, the 
MRLs should be reconsidered and revised by risk managers following the finalisation 
of that procedure.  
(3) Additionally, the  Authority identified an exceedance of the ARfD of dithianon for 
apples and pears. The Authority consulted the Member States and requested them to 
report potential fall -back Good Agricultural Practices (GAPs)  for apples and pears , 
authorised in  Member Stat es or  third countries and already evaluated at Member State 
level, which would not lead to an unacceptable risk for consumers. Fall -back GAPs for 
apples and pears were identified that do not lead to exceedances of the ARfD  of 
dithianon . It is therefore appropriate to lower  the MRLs for dithianon on apples and 
pears to the values identified by the Authority in Part A of  Annex III to Regulation 
(EC) No  396/2005 . 
 
1 OJ L 70, 16.3.2005, p. 1.  
2  European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for dithianon  according to Article 12 of Regulation (E C) No 396/2005. EFSA Journal 
2023;21(1):7731 . 
3  European Food Safety Authority; Conclusion on the u pdated peer review of the pesticide risk 
assessment for the active substance dithianon in light of confirmatory data submitted . EFSA Journal 
2020;18(9):6189 .  
EN 2  EN (4) The Commission consulted the European Union reference laboratories for residue s of 
pesticides as regards the need to adapt certain LODs  for dithianon . Those laboratories 
proposed product -specific LODs that are analytically  achievable.  
(5) Through the World Trade Organisation, the trading partners of the Union were 
consulted on the new MRLs  for dithianon  and their comments have been taken into 
account.  
(6) Annex III to Regulation (EC) No  396/2005 should therefore be amended accordingly.  
(7) A reasonable period should be allowed to elapse before the new MRLs for dithianon  
become applicable , in order to permit Member States, third countries and food 
business operators to adapt themselves to the requirements which result  from the 
modification of the MRLs .  
(8) 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  
Part A of Annex  III to Regulation (EC) No  396/2005 is amended in accordance with the 
Annex to this Regulation.  
Article 2 
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 … [ 6 months after the date  of entry into force of this Regulation ]. 
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