G/TBT/N/EU/583  
 
5 July 2018  
(18-4236) 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 Commission  
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/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 applica ble, 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 Regulation concern ing the non -renewal of approval of the active 
substance etoxazole, 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 Commission Impl ementing Regulation (EU) No 540/2011 
(4 page(s), in English)    
6. Description of content: This draft Commission Implementing Regulation provides that 
the approval of the active substance etoxazole is not renewed in accordance with 
Regulation (EC) No 1107/2009. Existing authorised plant protection products containing 
etoxazole will be withdrawn from the market. The non -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 approved under 
Directive  91/414/ EEC.  
This decision only concerns the placing on the market of this substance and does not affect 
the Maximum Residue Levels (MRLs) for residues of the concerned pesticide. Howeve r, 
following non -approval, separate action may be taken on MRLs. Any subsequent action on 
MRLs will be subject to notification under the SPS procedure.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of hum an health or safety; protection of animal or plant life or 
health; protection of the environment.  
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 ma rket), it 
must be demonstrated that the substance is not harmful to human health, animal health or G/TBT/N/EU/583  
 
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  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 evaluat ion 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).  
In particular, EFSA concluded that the consumer dietary risk as sessment cannot be finalised 
because of the outstanding data to conclude on the residue definition for risk assessment for 
processed commodities and the fate of persistent soil metabolites in rotational crops.  
In addition, EFSA also concluded that there i s a high risk to aquatic invertebrates for all 
representative uses, a high risk for non -target arthropods for all representative uses 
evaluated and in particular, a high risk for soil mites for representative uses in tomato, 
cucurbit, ornamentals, pome/sto ne fruit, grapes, strawberry and cotton.  
Furthermore, etoxazole is a bioaccumulative and toxic substance in accordance with points 
3.7.2.2 and 3.7.2.3 respectively, of Annex II to Regulation (EC) No 1107/2009.  
These concerns mean that etoxazole does not m eet the approval criteria as outlined in 
Regulation (EC) No 1107/2009 and cannot be approved currently.  
Existing authorisations will need to be withdrawn; Member States must withdraw existing 
plant protection products containing etoxazole at the latest by 6 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 15 months from the entry into force.  
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:32009R1107&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, 11.6.2011, 
p. 1–186). http://eur -lex.europa.eu/legal -
content/EN/TXT/?qid=1442928512004&uri=CELEX:32011R0540  
 EFSA (European Food Safety Authority), 2017. Conclusion on the peer re view of 
the pesticide risk assessment of the active substance etoxazole. EFSA Journal 
2017;15(10):4988, 27 pp. doi: 10.2903/j.efsa.2017.4988 
https://www.efsa.europa.eu/en/efsajournal/pub/49 88 
9. Proposed date of adoption: 4th quarter 2018  
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/2018/TBT/EEC/18_3501_00_e.pdf