EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2022/2157  
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the 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) No 540/2011  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the 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) No 540/2011  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Fu nctioning of the European Union,  
Having regard to 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  79/11 7/EEC an d 91/414/EEC1, and in particular 
Article  20(1)   and Article 78(2) thereof,  
Whereas:  
(1) Commission Directive 2009/77/EC2 included triflusulfuron -methyl  as an active 
substance in Annex I to Council Directive 91/414/EEC3. 
(2) Active substances included in Annex I to  Directive 91/414/EEC are deemed to have 
been approved under Regulation (EC) No 1107/2009 and are listed in Part  A of the 
Annex to Commission Implementing Regulation (EU) No  540/20114. 
(3) The approval of the active substance triflusulfuron -methyl , as set out in Part A of the 
Annex to Implementing Regulation (EU) No 540/2011, expires on 31 December  2023 . 
(4) An application for the renewal of the approval of the active substance triflusulfuron -
methyl  was submitted to France , the rapporteur Member State, and Denmark , the co -
rapporteur Member State, in accordance with Article 1 of Commission Implementing 
Regulation (EU) No 844/20125 within the time period provided for in that Article.  
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Directive 2009/77/EC of 1 July 2009 amending Council Directive 91/414/EEC to include 
chlorsulfuron, cyromazine, dimethachlor, etofenprox, lufenuron, penconazole, tri -allate and 
triflusulfuron as active substances (OJ L 172, 2.7.2009, p. 23 ). 
3 Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on 
the market (OJ L 230, 19.8.1991, p. 1).  
4 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).  
5 Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the 
provisions necessary for the implementation of  the renewal procedure for active substances, as provided 
for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the 
placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26). That Implementing  
Regulation was replaced by Commission Implementing Regulation (EU) 2020/1740, however, it 
continues to apply to the procedure for the renewal of the approval of active substances: (1) whose 
approval period ends before 27 March 2024; (2) for which a Regulatio n, adopted in accordance with 
 EN 2  EN (5) The applicant submitted the supplementary dossiers required  to the rapporteur 
Member State, the co -rapporteur Member State, the Commission and the European 
Food Safety Authority (‘the Authority’) in accordance with Article 6 of Implementing 
Regulation (EU) No 844/2012. The application was found to be admissible  by the 
rapporteur Member State.  
(6) The rapporteur Member State prepared a draft renewal assessment report in 
consultation with the co -rapporteur Member State and submitted it to the Authority 
and the Commission on 26 July 2019. In its draft renewal assessment report France  
proposed to not renew the approval of triflusulfuron -methyl.   
(7) The Authority made the supplementary summary dossier available to the public. The 
Authority also circulated the draft renewal assessment report to the applicant and to 
the Member S tates for comments and launched a public consultation on it. The 
Authority forwarded the comments received to the Commission.  
(8) On 1 April 2022 , the Authority communicated to the Commission its conclusion6 on 
whether triflusulfuron -methyl  can be expected to meet the approval criteria provided 
for in Article 4 of Regulation (EC) No 1107/2009.  
(9) The Authority identified a  critical concern in relation to the contamination of 
groundwater by one toxicologically relevant metabolite of triflusulfur on-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 triflusulfuron -methyl. Therefore, it cannot currently be esta blished 
that the presence of metabolites of triflusul furon-methyl in groundwater will have no  
unacceptable effects on groundwater and no harmful effects on human health , as 
required by Article  4(3), point (b), of Regulation (EC) No  1107/2009.  
(10) Furthermore, the Authority  concluded that triflusulfuron -methyl  has endocrine 
disrupting properties that may cause adverse effects  in humans , as set out  in point  3.6.5 
of Annex II to Regulation (EC) No 1107/20097. According to the Authority, n egligible 
exposure cannot be demonstrated for triflusulfuron -methyl  since residues above  the 
default value set out in Article  18(1) , point (b),  of Regulation (EC) No 396/2005  of the 
European Parliament and of the Council8 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.  The Authority also concluded that the consumer dietary 
risk assessment could not be finalised .  
(11) In its evaluation of whether triflusulfuron -methyl  is necessary to control a serious 
danger to plant health which cannot be contained by other available means including 
non-chemical methods  in accordance with Article 4(7) of Regulation (EC) 
No 1107/2009, the Authority concluded that for some uses and in some Member 
States , there may be an insufficient number of chemical alternatives available at the 
                                                                                                                                                         
Article 17 of Regulation (EC) No 1107/2009 on or after 27 March 2021, extends the approval period to 
27 March 2024 or a later date . 
6 Peer review of the pesticide risk assessment of the active substance t riflusulfuron -methyl (EFSA 
Journal 2022;20(5):7303 ; https://doi.org/10.2903/j.efsa.2022.730 ). 
7 Commission Regulation (EU) 2018/605 of 19 April 2018 amending  Annex II to Regulation (EC) 
No 1107/2009 by setting out scientific criteria for the determination of endocrine disruptin g properties 
(OJ L 101, 20.4.2018, p. 33).  
8 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23  February 2005 on 
maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending 
Council Direc tive 91/414/EEC ( OJ L 70, 16.3.2005, p. 1).  EN 3  EN time of assessment. However, some  non-chemical methods are available ( for instance, 
mechanical weeding), although they may not have the same efficacy as chemical 
methods and/or they may  present economic or other feasibility limitations. In addition, 
further chemical alternatives could be made available in the Member States concerned 
via mutual recognition of alternative products that are available in other Member 
States , as provided for in Article 40 of Regulation (EC) No 1107/2009. In addition, the 
Commission considers that no serious danger to plant health has been identified. 
Therefore, the Commission consi ders that the conditions for the application of the 
derogation in Art icle 4(7) of Regulation (EC) No  1107/2009 are not fulfilled.  
(12) The Commission presented a renewal report   on 14 October 2022 and a draft of this 
Regulation to the Standing Committee on Pla nts, Animals, Food and Feed on  
11 July 2023 . 
(13) The Commission invited the applicant to submit its comments on the conclusion of the 
Authority. Furthermore, in accordance with Article 14(1) , third subparagraph,  of 
Implementing Regulation (EU) No 844/2012, the  Commission invited the applicant to 
submit comments on the renewal report. The applicant submitted its comments, which 
have been carefully examined.  
(14) Despite the arguments put forward by the applicant, the concerns regarding the active 
substance   could not  be eliminated.  
(15) Consequently, it has not been  established with respect to one or more representative 
uses of at least one plant protection product that the approval criteria provided for in 
Article 4 of Regulation (EC) No  1107/2009 are satisfied. It is th erefore appropriate not 
to renew the approval of the active substance triflusulfuron -methyl  in accordance with 
Article  20(1) , point (b), of that Regulation.   
(16) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly.  
(17) Member States sh ould be given  sufficient time to withdraw authorisations for plant 
protection products containing triflusulfuron -methyl . 
(18) For plant protection products containing triflusulfuron -methyl , where Member States 
grant any grace period in accordance with Article 46 of Regulation (EC) 
No 1107/2009, that period should  not exceed 9 months  from the date of entry into 
force of this Regulation . 
(19) Commission Implementing Regulation (EU) 2022/14809 extended the approval period  
of triflusulfuron -methyl  to 31 December  2023  in order to allow the renewal process to 
be co mpleted before the expiry of the approval period  of that active substance .  
                                                 
9 Commission Implementing Regulation (EU) 2022/1480 of 7  September 2022 amending Implementing 
Regulation (EU) No  540/2011 as regards the extension of the approval periods of the active substances 
2-phenylphenol (including its salts such as the sodium salt), 8 -hydroxyquinoline, amidosulfuron, 
bensulfuron, bifenox, chlormequat, chlorotoluron, clofentezine, clomazone, daminozide, deltamethrin, 
dicamba, difenoconazole, diflufenican, dimethachlor, esfenvalerate, etofe nprox, fenoxaprop -P, 
fenpropidin, fenpyrazamine, fludioxonil, flufenacet, flumetralin, fosthiazate, lenacil, MCPA, MCPB, 
nicosulfuron, paraffin oils, paraffin oil,  penconazole, picloram, prohexadione, propaquizafop, 
prosulfocarb, quizalofop -P-ethyl, quizal ofop-P-tefuryl, sodium 5 -nitroguaiacolate, sodium o -
nitrophenolate, sodium p -nitrophenolate, sulphur,  tebufenpyrad, tetraconazole, tri -allate, triflusulfuron 
and tritosulfuron  (OJ L 233, 8.9.2022, p. 43).  EN 4  EN (20) Taking into account that the current approval of triflusulfuron -methyl  expires on 31 
December  2023 , this Regulation should enter into fo rce as soon as possible.  
(21) This Regulation does not prevent  the submission of another  application for the 
approval of triflusulfuron -methyl  pursuant to  Article 7 of Regulation (EC) 
No 1107/2009.  
(22) The measures provided for in this Regulation are in accordance with the opinion of the  
Standing Committee on Plant s, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Non-renewal of the approval of the active substance  
The approval of the active substance triflusulfuron -methyl  is not renewed.   
Article 2 
Amendment  to Implementing Regulation (EU) No 540/2011  
In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row  289 on 
triflusulfuron -methyl  is deleted.  
Article 3 
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
triflusulfuron -methyl  as an active substance by  … [Office of Publications : please insert date 
3 months  from the date of entry into force  of this Implementing Regulation ].  
Article 4 
Grace period  
Any grace period granted by Member States  in accordance with Article 46 of Regulation (EC) 
No 1107/2009 shall expire by  … [Office of Publications : please insert date 9 months  from the 
date of entry into force  of this Implementing Regulation ]. 
Article 5 
Entry into force   
This Regulation shall enter into force on the third day following that of its publication in the 
Official Journal of the European Union .  
This Regulation shall be binding in its entirety and directly applicable in a ll Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN