G/SPS/N/EU/502  
 
12 August 2021  
(21-6186) Page: 1/3 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION  
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved:   
2. Agency responsible:  European Commission, Health and Food Safety Directorate -General  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Indoxacarb (pesti cide active substance); Pesticides and other 
agrochemicals (ICS Code: 65.100)  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Draft Commission Implementing Regulation 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 p lant protection products on the market, and amending Implementing 
Regulation (EU) No 540/2011 (Text with EEA relevance) . Language(s):  English . Number 
of pages:  5 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_5151_00_s.pdf  
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 plant 
protection products contai ning 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 formerly 
assessed and approved und er Directive 91/414/ EEC.  
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 huma n health, animal health 
or the environment. Criteria are listed in Article 4 of the Regulation (and 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 finalised 
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, a dditionally, 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 membe r States must withdraw existing plant protection 
products containing indoxacarb at the latest by three  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 G/SPS/N/EU/502  
 
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  shall expire at the latest  six months from the entry into force.  
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 containing this su bstance, separate action will likely be 
taken on MRLs and a separate notification will be made in accordance with 
SPS procedures.  
This draft Commission Implementing Regulation was also notified under the 
TBT Agreement in notice G/TBT/N/EU/827.  
7. Objecti ve and rationale: [X]  food safety, [  ] animal health, [X]  plant protection, 
[ ] protect humans from animal/plant pest or disease, [X]  protect territory from 
other damage from pests.   
8. Is there a relevant international standard? If so, identify the stand ard: 
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) :  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language(s) in which these are available:   
− Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 
21 October 2009 concerning the 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 o f the 
Council as regards the list of approved active substances (OJ L 153, 11  June 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 (Europ ean 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 .efsa.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   
10. Proposed date of adoption (dd/mm/yy) : 4th quarter 2021  
Proposed date of publication (dd/mm/yy) : 4th quarter 2021  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : 20 days following publication in the Official Journal of the European Union.  
[ ] Trade facilitating measure   G/SPS/N/EU/502  
 
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  12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable. Comments are only welcomed on 
TBT related issues and to be addressed to the TBT Enquiry Point on notice 
G/TBT/N/EU/827.  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address (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  
13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (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