G/SPS/N/EU/515  
 
23 November 2021  
(21-8834) 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):  Sulfoxaflor (pest icide 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 amending 
Implementing Regulations (EU) No 2015/1295 and No  540/2011 as regards the conditions 
of approval of the active substance sulfoxaflor (Text with EEA relevance) . Language(s):  
English . Number of pages:  5+2 (Annexes)  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_7283_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_7283_01_e.pdf  
6. Description of content:  This draft Commission Implementing Regulation provides that 
the approval conditions of the active 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 sulfoxa flor for 
use in the E uropean Union . Existing 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. F ollowing 
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 d ue time.  
This draft Commission Implementing Regulation was also notified under the 
TBT Agreement in notice G/TBT/N/EU/853.  
7. Objective and rationale: [X]  food safety, [X]  animal health, [X]  plant protection, 
[ ] protect humans from animal/plant pest or d isease, [  ] protect territory from 
other damage from pests.   
8. Is there a relevant international standard? If so, identify the standard:  
[ ] 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) :  G/SPS/N/EU/515  
 
- 2 - 
 
  [ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed regulation conform to the relevant international st andard?  
[ ] 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  
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 P arliament and of the 
Council as regards the list of approved active substances (OJ L 153, 11  June 2011, 
p. 1-186) 
http://eur -lex.europa.eu/legal -
content/E N/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 (Euro pean 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 sulfoxaf lor 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   
10. Proposed date of adoption (dd/mm/yy) : 1st quarter 2022  
Proposed date of publication (dd/mm/yy) : 1st quarter 2022  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : 20 days following publication in the Of ficial Journal of the European Union.  
[ ] Trade facilitating measure   
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 b e addressed to the TBT Enquiry Point on notice G/TBT/N/EU/853.  
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  G/SPS/N/EU/515  
 
- 3 - 
 
  13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other bo dy:  
European Commission  
EU-TBT Enquiry Point  
Fax: +(32) 2 299 80 43  
E-mail: grow -eu-tbt@ec.europa.eu