G/TBT/N/EU/993  
13 July 2023  
(23-4752) Page: 1/3 
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/tbt/en/  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CC CN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  
triflusulfuron -methyl (pesticide active substance)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Imp lementing Regulation concerning the non -renewal of approval of the 
active substance triflusulfuron -methyl, in accordance with Regulation (EC) No 1107/2009 
of the European Parliament and of the Council, and amending Commission Implementing 
Regulation (EU) N o 540/2011; (5 page(s), in English)  
6. Description of content:  This draft Commission Implementing Regulation provides that 
the approval of the active substance triflusulfuron -methyl is not renewed in accordance 
with Regulation (EC) No 1107/2009. Member St ates shall withdraw authorisations for 
plant protection products containing triflusulfuron -methyl as an active substance. The 
non-renewal of 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 assessed and approved under Directive 91/414/ EEC.  
This decision only concerns the placing on the market of this substance and plant 
protection products containing it. Following non-approval and the expiry of all grace 
periods for stocks of products containing this substance, separate action may be taken 
on MRLs and a separate notification will be made in accordance with SPS procedures.  
7. Objective and rationale, including the n ature 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 G/TBT/N/EU/993  
 
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  be demonstrated that the substance is n ot 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.  
During the evaluation and peer -review of triflusulfuron -methyl, 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).  
EFSA identified a critical area of concern in relation to the contamination of groundwater 
by one toxicologically relevant metabolite of triflusulfuron -methyl, IN -JU122, which is 
predicted to occur above the parametric value of 0,1 μg/L in all geoclimatic conditions 
represented by the groundwater assessment scenarios for all proposed uses of 
triflusulf uron-methyl. Therefore, it cannot currently be established that the presence of 
metabolites of triflusulfuron -methyl in groundwater will not result in unacceptable effects 
on groundwater and in harmful effects on human health as required by Article 4(3)(b)  of 
Regulation (EC) No 1107/2009.  
Furthermore, EFSA concluded that triflusulfuron -methyl has endocrine disrupting 
properties in humans in accordance with the criteria laid down in point 3.6.5 of Annex II 
to Regulation (EC) No 1107/2009, as amended by Commi ssion Implementing Regulation 
2018/605. Negligible exposure cannot be demonstrated for triflusulfuron -methyl since 
residues above the default value set in accordance with point (b) of Article 18(1) of 
Regulation (EC) No 396/2005 may be expected to occur in  rotational crops. Therefore, 
the requirement set out in point 3.6.5 of Annex II to Regulation (EC) No 1107/2009 is 
not fulfilled.  
EFSA also concluded that the consumer dietary risk assessment could not be finalised as 
the livestock and fish exposure asses sments could not be finalised.  
Derogation in accordance with Article 4(7) to Regulation (EC) No 1107/2009 does not 
apply for the reasons set out in the draft Regulation.  
These concerns mean that triflusulfuron -methyl does not meet the approval criteria as 
outlined in Regulation (EC) No 1107/2009.  
Existing authorisations will need to be withdrawn; Member States must withdraw existing 
plant protection products containing triflusulfuron -methyl at the latest by 3 months from 
the date of entry into f orce. A period of grace in line with Article 46 of Regulation 
1107/2009 is allowed for and shall expire at the latest 9 months from the entry into force 
(allowing for a final season of use).  
Protection of human health or safety; Protection of animal or pla nt 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 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  
Conclusion on the peer review of the pesticide risk assessment of the active substance 
triflusulfuron -methyl.  
Peer review of the pesticide risk assessment of the active substance triflusulfuron ‐methyl 
| EFSA (europa.eu)  G/TBT/N/EU/993  
 
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  9. Proposed date of adoption:  4 quarter 2023  
Proposed date of entry into force:  three 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/2023/TBT/EEC/23_10998_00_e.pdf