G/TBT/N/EU/827  
 
 
  
2 August 2021  
(21-6022) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  EUROPEAN UNION   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  European Commission  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
European Comm ission,  
EU-TBT Enquiry Point,  
Fax: +(32) 2 299 80 43,  
E-mail: grow-eu-tbt@ec.europa.eu  
Website: http://ec.europa.eu/growth/tools -databases/tb t/en/  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  indoxacarb 
(pesticide active substance); Pesticides and other agrochemicals (ICS 65.100)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Implementing Regulation concerning the non -renewal of approval of the 
active sub stance 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 Implementing Regulation (EU) No 540/2011 (5 
page(s), in English ) 
6. Description of content:  This draft Commission Implementing Regulation provides that 
the approval of the active substance indoxacarb is not renewed in accordance with 
Regulation (EC) No 1107/2009. EU Member States shall withdraw authorisations for pla nt 
protection products containing indoxacarb as an active substance. The non -renewal of 
approval is based on the first evaluation of the substance for use as a pesticide active 
substance in the EU under Regulation (EC) No 1107/2009. The substance was forme rly 
assessed and approved under Directive 91/414/ EEC.  
This decision only concerns the placing on the market of this substance and plant 
protection products containing it. Following non -approval and the expiry of all grace 
periods for stocks of products co ntaining this substance, separate action will likely be 
taken on MRLs and a separate notification will be made in accordance with SPS 
procedures.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  In order for an active substance to be approved in accordance with 
Regulation (EC)  No 1107/2009 (concerning the placing of plant protection products on 
the market), it must be demonstrated that the substance is not harmful to human health, 
animal health o r the environment. Criteria are listed in Article 4 of the Regulation (and G/TBT/N/EU/827  
 
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  also detailed in Annex  II thereto) which must be met to enable approval. uring the 
evaluation and peer -review of indoxacarb, a number of concerns and areas that could not 
be finalis ed were identified. These are detailed in the conclusion of the European Food 
Safety Authority (EFSA). The EFSA identified a critical concern in relation to the high long -
term risk to wild mammals for all representative uses and, additionally, a high risk to 
consumers and workers for the representative use in lettuce and a high risk to bees for 
the representative use in maize, sweet corn and lettuce for seed production. Furthermore, 
there are several areas of the risk assessment not finalised due to lack of  data in the 
dossier. These concerns mean that indoxacarb does not meet the approval criteria as 
outlined in Regulation (EC) No 1107/2009 and cannot be approved currently. Existing 
authorisations will need to be withdrawn; EU Member States must withdraw ex isting plant 
protection products containing indoxacarb at the latest by 3 months from the date of 
entry into force. A period of grace in line with Article 46 of Regulation 1107/2009 is 
allowed for and shall expire at the latest 6 months from the entry into  force.; Protection 
of human health or safety; Protection of animal or plant life or health; Protection of the 
environment . 
8. Relevant documents:   
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 
October 2009 concerning th e placing of plant protection products on the market and 
repealing Council Directives 79/117/EEC and 91/414/EEC:  
EUR-Lex - 32009R1107 - EN - EUR-Lex (europa.eu)  
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 approved active substances ( OJ L 153, 11.6.2011, p. 1 –186) 
EUR-Lex - 32011R0540 - EN - EUR-Lex (europa.eu)  
Conclusion on the peer review of the pesticide risk assessment of the active substance 
indoxacarb.  
EFSA (European Food Safety Authority). 2018. Conclusion on the peer review of the 
pesticide risk assessment of the active substance indoxacarb. EFSA Journal 2018; 
16(1):5140,29pp. https://www.efs a.europa.eu/en/efsajournal/pub/5140  
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 pp https://www.efsa.europa.eu/en/efsajournal/pub/5866  
9. Proposed date of adoption:  4th quarter 2021  
Proposed date of entry into force:  20 days following publication in the Official Journal 
of the EU  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
European Commission,  
EU-TBT Enquiry Point,  
Fax: + (32) 2 299 80 43,  
E-mail: grow-eu-tbt@ec.europa.eu  
 
The text is available on the EU -TBT Website : http://ec.europa.eu/growth/tools -
databases/tbt/en/  
https://members.wto.org/crnattachments/2021/TBT/EEC/21_5017_00_e.pdf