G/TBT/N/EU/853  
17 November 2021  
(21-8686) 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):  Sulfoxaflor 
(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 amending Implementing Regulations (EU) No 
2015/1295 and  No 540/2011 as regards the conditions of approval of the active substance 
sulfoxaflor (5 page(s), in English; 2 page(s), in English)  
6. Description of content:  This draft Commission Implementing Regulation provides that 
the approval conditions of the act ive substance sulfoxaflor are amended in accordance 
with Regulation (EC)  No 1107/2009 based on the evaluation of confirmatory data as 
required in Regulation (EU) 2015/1295 of 27 July 2015 approving the active substance 
sulfoxaflor for use in the EU. Existi ng authorised plant protection products containing 
sulfoxaflor will be reviewed in accordance with the restriction set in this act.  
This decision however 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 legal action will likely be taken on Maximum Residue Levels 
and a separate notification will be made in accordance with SPS procedures in due time.  
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 demonstrate d 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 thereto) which must be met to enable approval. Regulation (EU) 
No 2015/1295 approved su lfoxaflor as active substance for use in plant protection 
products and required the applicant to provide confirmatory information with regard to 
bees. Following the assessment of confirmatory information, the information provided did G/TBT/N/EU/853  
 
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  not demonstrate absenc e of risks to bees, in particular bumble bees and solitary bees, 
from outdoor use. Consequently, the notified draft Implementing Regulation aims at 
restricting the conditions of approval of the active substance sulfoxaflor to uses in 
permanent greenhouses only in order to protect bees. The decision is based on a risk 
assessment peer reviewed at EU level, under the lead of the European Food Safety 
Authority. EU Member States shall, where necessary, withdraw or amend authorisations 
for plant protection produc ts containing sulfoxaflor as active substance at the latest by 6 
months from the date of entry into force. EU Member States may grant a period of grace 
in line with Article 46 of Regulation No  1107/2009 which shall expire at the latest 12 
months from the e ntry into force of the notified draft Implementing Regulation.; 
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 20 09 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), 2018. Technical report on the outcome 
of the consultation with Member States, the applicant and EFSA on the pesticide 
risk assessment of confirmatory data for sulfoxaflor in light of confirmatory 
data. EFSA supporting  publication 2018:EN -1474. 73 pp. 
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2018.EN -1474 
• EFSA (European Food Safety Authority), 2019. Conclusion on the peer review of 
the pesticide risk assessment for the active substance sulfoxaflor in light of 
confirmatory data submitted. EFSA Journal 2019;17(3):5633, 14 pp. 
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2019.5633  
• EFSA (European Food Safety Authority), 2020. Conclusion on the peer review of 
the pesticide risk assessment for the active substance sulfoxaflor in light of 
confirmatory data submitted. EFSA Journal 2020;18(3):6056, 15 
pp.  https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2020.6056  
9. Proposed date of adoption:  1st Quarter 2022.  
Proposed dat e 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://memb ers.wto.org/crnattachments/2021/TBT/EEC/21_7189_00_e.pdf  
https://members.wto.org/crnattachments/2021/TBT/EEC/21_7189_01_e.pdf