G/TBT/N/EU/733  
17 August 2020  
(20-5587) 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/tbt/e n/ 
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):  Etoxazole 
(pesticide active substance)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Implementing Regu lation renewing the approval of the active substance 
etoxazole as a candidate for substitution 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 the Annex to Commission 
Implementing Regulation (EU) No 540/2011 (5 page(s), in English; 3 page(s), in English)  
6. Description of content:  This draft Commission Implementing Regulation provides that 
the approval of the active substance etoxaz ole is renewed as a candidate for substitution 
in accordance with Regulation (EC)  No 1107/2009. It is however, necessary to include 
certain conditions and restrictions. In particular, only use on ornamental plants in 
permanent greenhouses can be approved.  
Existing authorised plant protection products containing etoxazole will be reviewed in 
accordance with the restrictions. The restriction is based on the first evaluation of the 
substance for use as a pesticide active substance in the EU under Regulation (E C) 
No 1107/2009. The substance was formerly approved under Directive 91/414/EEC.  
This decision only concerns the placing on the market of this substance. Following 
restriction of the approval and the consequent expiry of all grace periods for stocks of 
products, separate action will likely be taken on MRLs and a separate notification w ill be 
made in accordance with SPS procedures.  G/TBT/N/EU/733  
 
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  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 or the environment. Criteria are listed in Article 4 of the Regulation (and 
also detailed in Annex  II) which must be met to enable approval. During the evaluation 
and peer -review of etoxazole, 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). EFSA concluded high risk to non-target arthropods and the consumer 
dietary risk assessment could not been finalised considering the outstanding data to 
conclude on the residue definition for risk assessment for processed commodities. These 
concerns mean that etoxazole meets the appro val criteria as outlined in Regulation (EC) 
No 1107/2009 only if the approval is restricted to use on ornamental plants in permanent 
greenhouses. Existing authorisations will need to be amended or withdrawn following 
renewal of authorisation in accordance with Article 43 of Regulation (EC) No 1107/2009.; 
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 the placing of plant protection products on the 
market and repealing Council Directives 79/117/EEC and 91/414/EEC: 
http://eur -lex.europa.eu/legal -
content/EN/TXT/PDF/?uri=CELEX:320 09R1107&qid=1437730988988&from=EN  
• 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, 
11.6.2 011, p. 1 –186) http://eur -lex.europa.eu/legal -
content/EN/TXT/?qid=1442928512004&uri=CELEX:32011R0540  
• Conclusion on the peer review of the pesticide risk assessment of the active 
substance etoxazole.  
• EFSA (European Food Safety Authority), 2017. Conclusion on the peer review of 
the pesticide risk assessment of the active substance etoxazole. EFSA Journal 
2017;15(10):4988.  
9. Proposed date of adoption:  4th quarter 2020  
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/2020/TBT/EEC/20_4938_00_e.pdf  
https://members.wto.org/crnattachments /2020/TBT/EEC/20_4938_01_e.pdf