EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10729/2018 rev. 6  
[…](2020) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
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 placing of plant protection products on the market, and 
amending Impleme nting Regulation (EU) No 540/2011  
(Text with EEA relevance)   EN 2  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
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 placing of plant protection products on the market, and 
amending Impleme nting Regulation (EU) No 540/2011  
(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 1107/2009 of the European Parliament and of the 
Council of 21 Oct ober 2009 concerning the placing of plant protection products on the market 
and repealing Council Directives  79/117/EEC and 91/414/EEC1, and in particular 
Article  20(1) (b) and Article 78(2) thereof , 
Whereas:  
(1) Commission Directive 2006/10/EC2 included indoxa carb as an active substance in 
Annex  I to Council Directive  91/414/EEC3. 
(2) Active substances included in Annex I to Directive 91/414/EEC are deemed to have 
been approved under Regulation (EC) No 1107/2009 and are listed in Part  A of the 
Annex to Commission Implementing Regulation (EU) No  540/20114. 
(3) The approval of the active substance indoxacarb , as set out in Part A of the Annex to 
Implementing Regulation (EU) No 540/2011 , expires on 31 October  2021. 
(4) An application for the renewal of the approval of indoxacarb  was submitted in 
accordance with Article 1 of Commission Implementing Regulation (EU) 
No 844/20125 within the time period provided for in that Article.  
(5) The applicant submitted the supplementary dossiers required in accordance with 
Article  6 of Implementing Regulation (EU) No  844/2012. The application was found 
to be complete by the rapporteur Member State.  
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Directive 2006/10/EC of 27 January 2006 amending Council Directive 91/414/EEC to 
include forchlorfenuron and indoxacarb as active substances (OJ L 25, 28.1.2006, p.  24). 
3 Council Directive 91/414/EEC of 15 July 1991 concerning the placing of  plant protection products on 
the market (OJ L 230, 19.8.1991, p.  1). 
4 Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation 
(EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approv ed active 
substances (OJ L 153, 11.6.2011, p.  1). 
5 Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the 
provisions necessary for the implementation of the renewal procedure for active substances, as provided 
for in Regu lation (EC) No 1107/2009 of the European Parliament and of the Council concerning the 
placing of plant protection products on the market  (OJ L 252, 19.9.2012, p.  26). EN 3  EN (6) The rapporteur Member State prepared a draft renewal assessment report in 
consultation with the co -rapporteur Member State and submitted it to the European 
Food Safety Authority (‘the Authority’) and the Commission on 28 November  2016 . 
(7) The Authority made the supplementary summary dossier available to  the public. The 
Authority also circulated the renewal assessment report to the applicant and to the 
Member States for comments and launched a public consultation on it. The Authority 
forwarded the comments received to the Commission.  
(8) On 15 December  2017 , the Authority communicated to the Commission its 
conclusio n6 on whether indoxacarb  can be expected to meet the approval criteria 
provided for in Article  4 of Regulation (EC) No 1107/2009. The ecotoxicology section 
of this conclusion was amended in 2018 to clarify the risk assessment for bees 
according to the relevant  European Commission Guidance (SANCO/10329/2002 -
rev.2). On 15 May 2019, the Commission requested the Authority for an updated peer 
review concerning the risk to mammals and bees of indoxacarb. On 28 October 2019,  
the Authority adopted  a statement on the updated peer review concerning the risk to 
mammals and bees posed by the active substance indoxacarb7 which was reflected  in a 
second update of the Authority’s  conclusion on whether indoxacarb can be expected to 
meet the approval criteria provided for in Article  4 of Regulation (EC) No 1107/2009 . 
(9) A critical area of concern was identified by the Authority in relation to the high long-
term risk to wild mammals , in particular the long -term risk to small herbivorous 
mammals . 
(10) Additionally, a high risk to consumers and workers was identified for the 
representative use in lettuce and a high risk to bees was identified for the 
representative use in maize, sweet corn and lettuce for seed production.  
(11) Furth ermore, several areas of the risk assessment could  not be finalised due to 
insufficient data in the dossier. In particular , the consumer risk assessment could not be 
finalised due to lack of  data on rotational crop metabolism,  data regarding the 
metabolism in poultry, the magnitude of residues  in primary and rotational crops and data 
on the effect of water treatment processes on the nature of residues in drinking water. In 
addition,  the assessment concerning  groundwater exposure  for soil metabolite IN -U8E24 
could not be finalised due to lack of data on soil degradation  and adsorption . Similarly,  
the ecotoxicological risk assessment for several  metabolites  could not be finalised . 
(12) On 14 November 2018 , the applicant informed the Com mission of its decision to 
withdraw from the renewal application the representative use in lettuce.  
(13) The Commission invited the applicant to submit its comments on the conclusion  of the 
Authority , the revised conclusion and the statement . Furthermore, in ac cordance with 
the third subparagraph of Article 14 (1) of Implementing Regulation (E U) No 
844/2012, the Commission invited the applicant to submit comments on the draft 
renewal report. The applicant submitted its comments, which have been carefully 
examined . 
(14) However, despite the arguments put forward by the applicant, the concerns regarding 
the active substance  could not be eliminated.  
                                                 
6 EFSA Journal 2018;16(1):5140, 36 pp. doi:10.2903/j.efsa.2018.5140 . Available online: 
www.efsa.europa.eu . 
7 EFSA (European Food Safety Authority), 2019. Statement on the updated peer  review concerning the 
risk to mammals and bees for the active substance indoxacarb. EFSA Journal  2019;17(10):5866, 10 p p. EN 4  EN (15) Consequently, it has not been  established with respect to one or more representative 
uses of at least one plant protectio n product that the approval criteria provided for in 
Article  4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not 
to renew the approval of the active substance indoxacarb  in accordance with 
Article  20(1)(b) of that Regulation . 
(16) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly.  
(17) Member States should be allowed sufficient time to withdraw authorisations for plant 
protection products containing indoxacarb . 
(18) For plant protection products containing indoxaca rb, where Member States grant any 
grace period in accordance with Article  46 of Regulation (EC) No  1107/2009, that 
period should be as short as possible ] 
(19) Commission Implementing Regulation (EU) 2020/15118 extended the expiry date of 
indoxacarb  to 31 Octobe r 2021 in order to allow the renewal process to be completed 
before the expiry of the approval of that substance. However, g iven that a decision  on 
renewal has been  taken ahead of that extended expiry date, this Regulation should 
apply as soon as possible.   
(20) This Regulation does not prevent  the submission of a further application for the 
approval of indoxacarb  in accordance with  Article  7 of Regulation (EC) 
No 1107/2009.  
(21) 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  
Non-renewal of approval of active substance  
The approval of the active substance indoxacarb  is not renewed.   
Article 2  
Amendments to Implementing Regulatio n (EU) No 540/2011  
In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 119, on 
indoxacarb , is deleted.  
Article 3 
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
indoxacarb  as an active substance by [ Office of Publications please insert date 3 months from 
the date of entry into force ] at the latest.  
                                                 
8 Commission Implementing Regulation (EU) 2020/1511 of 16 October 2020 amending Implementing 
Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 
amidosulfuron, bifenox, chlorotoluron, clofentezine, cloma zone, cypermethrin, daminozide, 
deltamethrin, dicamba, difenoconazole, diflufenican, fenoxaprop -P, fenpropidin, fludioxonil, flufenacet, 
fosthiazate, indoxacarb, lenacil, MCPA, MCPB, nicosulfuron, paraffin oils, picloram, prosulfocarb, 
sulphur, triflusulfu ron and tritosulfuron ( OJ L 344, 19.10.2020 ). EN 5  EN Article 4 
Grace period  
Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) 
No 1107/2009 shal l expire by [Office of Publications please insert date 6 months from the 
date of entry into force] . 
Article 5 
Entry into force  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
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