EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/242 v4  
[…](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 indoxacarb 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 indoxacarb 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), and Article 18(1), point (b)  thereof,  
Whereas:  
(1) For the active substance indoxacarb , maximum residue levels ( ‘MRLs ’) were set in  
Annex II to Regulation (EC) No  396/2005 .  
(2) In the context of the procedure for the renewal of the approval of indoxacarb  in 
accordance with Regulation (EC) No 1107/2009 of the European Parliament and of  the 
Council2, the European Food Safety Authority (‘the Authority’) published a 
conclusion on the peer review of the risk assessment of that active substance3, 
establishing  a lower acceptable daily intake ( ‘ADI’) and a lower acute reference dose 
(‘ARfD ’). 
(3) The approval of the active substance indoxacarb expired  on 19 December 2021  and 
was non -renewed 4. All authorisations for plant protection products containing that 
active substance have been revoked .  
(4) In accordance with Article 43 of Regulation (EC) No  396/2005, the Commission 
requested the Authority to provide a reasoned opinion  on the risks that the current  
MRLs  for indoxacarb based on import tolerances and Codex maximum residue limits  
(‘CXLs ’) may pose to consumers in light of th e lower ADI and ARfD.  In its reasoned 
opinion5, the Authority identified unacceptable risks concerning the current MRLs 
 
1 OJ L 70, 16.3.2005, p. 1.  
2 Regulation (EC) No 1107/2009 of the European Parliament and of the Council  concerning the placing 
of plant p rotection products on the market and repealing Council Directives 79/117/EEC and 
91/414/EEC  (OJ L 309 24.11.2009, p. 1) . 
3 European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the 
active substance indoxacarb . EFSA Journal 201 8;16(1):5140 . 
4 Commission Implementing Regulation (EU) 2021/2081 of 26 November 2021 concerning the non -
renewal of approval of the active substance indoxacarb, in accordance with Regulation (EC) No 
1107/2009 of the European Parliament and of the Council concerning the pl acing of plant protection 
products on the market, and amending Commission Implementing Re gulation (EU) No 540/2011 
(OJ L 426, 29.11.2021, p. 28) . 
5 European Food Safety Authority; Targeted review of maximum residues levels (MRLs) for indoxacarb . 
EFSA Journal 2022;20(8):7527 .  
EN 2  EN based on CXLs  for apples, pears, apricots, cherries, peaches, plums, table and wine 
grapes, tomatoes, peppers, aubergines, cucumbers, gherkins, courgettes, melons, 
pumpkins, watermelons, broccoli, cauliflower and lettuce.   
(5) Furthermore, i n its conclusion6 on the peer review published in the context of the 
procedure for the renewal of the approval of indoxacarb , the Authority explained  that, 
due to insufficient data  on the toxicity and genotoxicity of various metabolites and 
degradation products formed duri ng processing  at high temperature , risks for human 
health could not be excluded.  Therefore, the MRLs based on CXLs cannot be 
confirmed as being safe for consumers . It is therefore appropriate to delete the MRLs 
set out for th is substance  in Annex  II to Regulation (EC) No 396/2005  in accordance 
with A rticle 17 of Regulation (EC) No  396/2005 in conjunction with Article 14(1)  
point (a) thereof . MRLs for indoxacarb on all products should instead be set  at the 
product  specific  limit of determination  (‘LOD ’) in Annex V to Regulation (EC) 
No 396/2005  in accordance with Article 18(1), point (b), of that Regulation . 
Additionally, as the MRLs on all products are set at the product  specific LODs, there 
is no longer a need for confirmatory data. Therefore, all footnotes containing requests 
for confirmatory data  should be deleted.   
(6) As regard s products for which no import tolerances or CXLs exi st, MRLs should be 
set at the product  specific LOD or the default MRL should ap ply, as provided for in 
Article  18(1) , point (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 active substances 
covered by this Regulation , those laboratories proposed product specific LODs that are 
analytically achievable.   
(8) Through the World Trade Organisation, the trad ing partners of the Union were 
consulted on the new MRLs  and their comments have been taken into account.  
(9) Annex es 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 MRL s 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 t he opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex es 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 .  
 
6 European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment o f the 
active substance indoxacarb. EFSA Journal 2018;16(1):5140 .  
EN 3  EN It shall apply from … [ Office of publications: please insert  date 6 months after the date of 
entry into force of t his 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