G/TBT/N/EU/633  
 
14 December 2018  
(18-7927) 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/   
3. Notified under Article 2.9.2 [  ], 2.10.1 [  ], 5.6.2 [ X], 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): 
Cyflumetofen (pesticide active substance)  
5. Title, number of pages and language(s) of the notified document: Draft 
Commission Implementing Regulation amending I mplementing Regulations (EU) 
No 22/2013 and (EU) No 540/2011 as regards the conditions of approval of the active 
substance cyflumetofen (4 pages + Annexes 3 pages, in English)   
6. Description of content: This draft Commission Implementing Regulation provides that 
the approval of the active substance cyflumetofen is amended as follows:  applications of 
plant protection products containing cyflumetofen, with the exception of applications 
made on non -soil-bound c rops in greenhouses, shall not be carried out from July to 
September.  
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.  
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 of addition al information submitted to address the confirmatory 
information requirements established in the approval of cyflumetofen, 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).  G/TBT/N/EU/633  
 
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  The Authority could not rule out a genotoxic potential for a ground water and surface 
water metabolite (metabolite B3).  
There is therefore a need to restrict the application of cyflumetofen based products to 
scenarios where the production of this metabolite is below the regulatory trigger value of 
0.1 µg/L in at least some groundwater FOCUS scenarios.  
Existing authorisations will need to be amended accordingly; EU Member States must 
review the existing authorisations for plant p rotection products containing cyflumetofen 
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 12 months 
after 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), 2016. Conclusion on the peer re view of 
the pesticide risk assessment for the active substance cyflumetofen in light of 
confirmatory data. EFSA Journal 2016;14(12):4635, 20 pp. 
doi:10.2903/j.efsa.2016.4635 
http://www.efsa.eur opa.eu/en/efsajournal/pub/4635  
• Commission Implementing Regulation (EU) No  22/2013 of 15  January 2013 
approving the active substance cyflumetofen, in accordance with Regulation (EC) 
No 1107/2009 of the European Parliament and of the Council concerning th e 
placing of plant protection products on the market, and amending the Annex to 
Commission Implementing Regulation (EU) No  540/2011. (OJ L 11, 16.1.2013, 
p. 8.)  
https://e ur-lex.europa.eu/legal -content/EN/ALL/?uri=CELEX:32013R0022  
9. Proposed date of adoption:  1st quarter 2019  
Proposed date of entry into force:  20 days from publication in the Official Journal of 
the European Union  
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 Website: http://ec.europa.eu/growth/tools -databases/tbt/  
https://members.wto.org/crnattachments/2018/TBT/EEC/18_6421_00_e.pdf  
https://members. wto.org/crnattachments/2018/TBT/EEC/18_6421_01_e.pdf