EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/947 v1  
[…](2023) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and V to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for oxamyl in or on 
certain products  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and V to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for oxamyl 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 Cou ncil Directive 91/414/EEC1, and in particular 
Article 14(1) , point (a) and Article 18(1) , point (b), thereof,  
Whereas:  
(1) For the active substance oxamyl , maximum residue levels ( ‘MRLs ’) were set in  
Annex  II to Regulation (EC) No  396/2005.  
(2) The approval of the active substance oxamyl expired on 1 May 20232. All 
authorisations for plant protection products containing that active substance will have 
been revoked by 1 November  2023.  
(3) In the context of the procedure for the renewal of the approv al of that active substance 
in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of 
the Council3, the European Food Safety Authority (‘the Authority’) published a 
conclusion on the peer review of the risk assessment of that activ e substance4, 
establishing a lower acceptable daily intake (ADI) and a lower acute reference dose 
(ARfD).  
(4) In accordance with Article 43 of Regulation (EC) No  396/2005, the Commission 
requested the Authority to provide a reasoned opinion, assessing the risks that the 
current MRLs , including those  based  on Codex maximum residue limits (CXLs) , for 
oxamyl , may pos e to consumers in light of those lower ADI and ARfD.  
 
1 OJ L 70, 16.3.2005, p. 1.  
2 Commission Implementing Regulation (EU) 2023/741  of 5 April 2023  concerning the non -renewal of 
approval of the active substance oxamyl, 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, and amending Commission  Implementing Regulation (EU) No 540/2011 (OJ  L 98, 11.04.2023 , 
p. 1). 
3 Regulation (EC) No 1107/2009 of the European Parliament and of the Council  concerning the placing 
of plant protection products on the market and repealing Council Directives 79/117/EE C and 
91/414/EEC  (OJ L 309 24.11.2009, p.  1). 
4 European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the 
active substance oxamyl. EFSA Journal 2022;20(5):7296 .  
EN 2  EN (5) In its reasoned opinion5, the Authority identified unacceptable chronic exposure risks  
for a wide range of diets,  as well as acute exposure risks  for a wide range of 
commodities, including for melons an d watermelons  for which MRLs are set  on the 
basis of CXLs . Therefore,  no MRL can be maintained and  MRLs for oxamyl in all 
products should be set at  the respective  limit s of determination (LOD) , which should 
be set in Annex V to Regulation (EC ) No 396/2005 in accordance with Article 18(1), 
point (b) of that Regulation . Additionally,  the footnote s indicating lack of  information 
on storage stability, crop metabolism and residue trials  should be deleted . 
(6) Additionally, the Authority identified that the default  LOD value of 0.01*  mg/kg does 
not provide a sufficient level of protection for consumers for  most commodities , so 
that the LOD for these products should be set at lower , more protective level s. 
(7) The Commission consulted the European Union reference laboratories for residues of 
pesticides as regards the need to adapt certain LODs. Those laboratories proposed 
product -specific LODs that are analytically achievable.   
(8) Through the World Trade Organisat ion, the trading partners of the Union were 
consulted on the new MRLs  and their comments have been taken into account.  
(9) Annex II and V to Regulation (EC) No  396/2005 should therefore be amended 
accordingly.  
(10) A reasonable period should be allowed to elapse before the new MRLs 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 .  
(11) 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 V to Regulation (EC) No  396/2005 are 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 … [Office of publications : please insert  date 3 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  
 
5 European Food Safety Authority; Statement on the risk assessment of maximum residue levels (MRLs)  
for oxamyl in view of consumer protection . EFSA Journal 2023;21(3):7823.  
EN 3  EN The President  
Ursula VON DER LEYEN