EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12482/2015 Rev.1  
[…](2015) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance triasulfuron, 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 Imple menting Regulation (EU) No 540/2011  
(Text with EEA relevance)    
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning  the non -renewal of approval of the active substance triasulfuron, 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 Implementing Re gulation (EU) No 540/2011  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council of 21 October 200 9 concerning the placing of plant protection products on the market 
and repealing Council Directives 79/117/EEC and 91/414/EEC1, and in particular 
Article  20(1) and Article 78(2)  thereof,  
Whereas:  
(1) Commission Directive 2000/66/EC2 included triasulfuron 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 triasulfuron , as set out in Part A of the Annex to 
Implementing Regulation (EU) No 540/2011, expires on 30  June 2016.  
(4) An application for the renewal of the inclusion of triasulfuron  in An nex I to Council 
Directive 91/414/EEC5 was submitted in accordance with Article 4 of Commission 
Regulation (E U) No 1141/20106 within the time period provided for in that Article.  
(5) The applicant submitted the supplementary dossiers  required in accordance with 
Article  9 of Regulation (E U) No 1141/2010.  The application  was found to be complete 
by the rapporteur Member State . 
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2  Commission Directive 2000/66/EC of 23 October 2000 including an active substance (tria sulfuron) in 
Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the 
market  (OJ L 276, 28.10.2000 , p. 35). 
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 ). 
 
6 Commission Regulation (EU) No 1141/2010  of 7 December 2010  laying down the procedure for the 
renewal of the inclusion of a second group of active substances in Annex I to Council 
Direc tive 91/414/EEC and establishing the list of those substances  (OJ L 322, 8.12.2010, p. 10) . 
  
EN 3   EN (6) The rapporteur Member State prepared a renewal assessment report in consultation 
with the co -rapporteur Member State and submitted it to the European Food Safety 
Authority (hereinafter ‘the Authority’) and the Commission on 14 October 2013 .  
(7) The Authority communicated the renewal assessment report to the applicant and to the 
Member States for comments and forwarded  the comments received to the 
Commission. The Authority also made the supplementary summary dossier available 
to the public.  
(8) On 8 January 2015  the Authority communicated to the Commission its conclusion7 on 
whether triasulfuron  can be expected to meet the  approval criteria provided for in 
Article  4 of Regulation (EC) No 1107/2009. The Authority concluded that , due to an 
incomplete genotoxic ity assessment of triasulfuron and its manufacturing impurit y 
CGA  150829 , it has not been possible to set the health based toxicological reference 
values. As a consequence, the assessment of the risk to consumers, operators, workers 
and bystanders could not be conducted. Furthermore, the Authority concluded that in 
specific ge oclimatic situations there is a high potential for the representative uses 
assessed to result in groundwater exposure above the parametric drinking water limit 
of 0.1μg/ l, either by triasulfuron  itself or by its soil metabolite CGA 150829 . In 
addition, a h igh risk to aquatic plants was identified.  
(9) The Commission invited the applicant to submit its comments on the conclusion of the 
Authority and, in accordance with Article 1 7(1) of Regulation (E U) No 1141 /2010, on 
the draft review report. The applicant subm itted its comments, which have been 
carefully examined.  
(10) However, despite the arguments put forward by the applicant, the concerns referred to 
in recital 8 could  not be eliminated.  
(11) Consequently, it has not been established that it may be expected that, with respect to 
one or more representative uses of at least one plant protection product containing 
triasulfuron , the approval criteria provided for in Article  4 of Regulation (EC) 
No 1107/2009 are satisfied. The approval of t he active substance triasulfuron  should 
therefore not be renewed . 
(12) Member States should be provided with time to withdraw authorisations for plant 
protection products containing triasulfuron .  
(13) For plant protection products containing triasulfuron , where Mem ber States grant any 
grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that 
period should, at the latest , expire  on 30  November  2016. 
(14) This Regulation does not prejudice the submission of a further application for 
triasulfuron  in accordance with  Article 7 of Regulation (EC) No 1107/2009.  
(15) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Non-renewal of approval of active substance  
The approval of the active substance triasulfuron  is not renewed .  
                                                 
7 EFSA Journal 2015;13( 1):3958 , 78 pp. doi:10.2903/j.efsa.2015. 3958. Available online: www.efsa.europa.eu .  
EN 4   EN Article 2  
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
triasulfuron  as active substance by [Office  of Publications please insert date 3 months after 
entry into force ]. 
Article 3 
Grace periods  
Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) 
No 1107/2009 shall be as short as possible and shall expire on 30  November  2016 at the 
latest.  
Article 4 
Amendments to Implementing Regulation (EU) No 540/2011  
In Part A of the Annex to Implementing Regulation (EU) No 540/2011 , row 9 on triasulfuron  
is deleted.  
Article 5 
Entry into force  
This Regulation shall enter into force on the 20th 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 all Member States.  
Done at Brussels,  
 For t he Commission  
 The President  
 Jean -Claude JUNCKER