G/TBT/N/EU/569  
 
1 May 2018  
(18-2698) 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 applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable): Flurtamone 
(pesticide active substance)  
5. Title, number of pages and language(s) of the notified document: Draft 
Commission Implementing Regulation concerning the non -renewal of approval of the active 
substance flurtamone, 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 Implementing Regulation (EU) No 540/2011 
(5 page(s), in English)    
6. Description of content: This draft Commission Implementing Regulation provides that 
the approval of the active substance flurtamone is not renewed in accordance with 
Regulation (EC)  No 1107/2009. Existing authorised plant protection products containing 
flurtamone will be withdrawn from the market.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 resi dues of the concerned pesticide. However, 
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 probl ems where 
applicable: Protection of human 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 market), it 
must be demonstrated that the substance is not harmful to human health, animal health or G/TBT/N/EU/569  
 
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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 evaluation and peer -review of flurtamone, 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, it was not possible to fully exclude the mutagenic potential of flurtamone and no 
final health -based reference values could be set. Consequently, the consumer and non -dietary 
risk asessements could not be conducted.  
In addition, the Authority concluded that the overall consumer risk assessment for 
exposure to metabolite trifluoroacetic acid, predicted to occur in groundwater in all 
pertinent scenarios and as a residue in plants, could not be finalised due to a number of 
deficiencies in the dossier.  
Furthermore, the assessment of endocrine disrupting properties could not be completed 
based on the available studies.  
These concerns mean that flurtamone does not meet 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 flurtamone at the latest by 6 months from the date of 
entry into force. A period of grace in line with Article 46 of Regulation 110 7/2009 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 updated  peer 
review of the pesticide risk assessment of the active substance flurtamone. EFSA 
Journal 2017;15(8):4976, 25 pp. https://doi.org/10.2903/j.efsa.2017.4976  
9. Proposed date of adoption: 3rd quar ter 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_2306_00_e.pdf