EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10316/2015 Rev. 0  
[…](2017) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance DPX KE 459 
(flupyrsulfuron -methyl), 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 mark et, and amending Commission Implementing 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 DPX KE 459 
(flupyrsulfuron -methyl), 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 am ending Commission Implementing Regulation 
(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 2009 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 2001/49 /EC2 included DPX KE 459 (flupyrsulfuron -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 an d are listed in Part A of the 
Annex to Commission Implementing Regulation (EU) No 540/20114. 
(3) The approval of the active substance DPX KE 459 (flupyrsulfuron -methyl) , as set out 
in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 
30 June 2017.  
(4) An application for the renewal of the inclusion of DPX KE 459 (flupyrsulfuron -
methyl)  in Annex I to Council Directive 91/414/EEC was submitted in accordance 
with Article 4 of Commission Regulation (EU) No 1141/20105 within the time period 
provided for in that Article.  
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Directive 2001/49/EC of 28 June 2001  amendi ng Annex I to Council 
Directive  91/414/EEC concerning the placing of plant -protection products on the market to include 
DPX KE 459 (flupyrsulfuron -methyl)  as an active substance  (OJ L 176, 29.6 .2001, p. 61). 
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 amending implementing 
Regulation (EC) No 1107/2009 of the European Parliament and of the  Council as re gards the list of 
approved active substances (OJ L 153, 11.6.2011, p. 1).  
5 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 
Directive 91/414/EEC and establishing the list of those substances  (OJ L 322, 8.12.2010, p. 10) . 
  
EN 3   EN (5) The applicant submitted the supplementary dossiers required in accordance with 
Article 9 of Regulation (EU) No 1141/2010.  The application was found to be complete 
by the rapporteur Member State.  
(6) The rapporteur Member State pre pared a renewal assessment report in consultation 
with the co -rapporteur Member State and submitted it to the European Food Safety 
Authority (‘the Authority’) and the Commission on 17 September  2013.  
(7) The Authority communicated the renewal assessment repor t 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 30 September 2016 the Authority communicated to the Comm ission its 
conclusion6 on whether DPX KE 459 (flupyrsulfuron -methyl)  can be expected to meet 
the approval criteria provided for in Article  4 of Regulation (EC) No 1107/2009. 
Based on  the studies assessed, the Authority concluded  that the parent substance h as 
certain intrinsic toxicological properties, in particular as regards to carcinogenicity and 
reproductive toxicity. In the view of the Authority this information even justifies the 
classification as carcinogen category 2 and as toxic for reproduction cat egory 2 in 
accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the 
Council7. The Authority concluded that considering the representative uses assessed, 
there is a high potential to result in groundwater exposure above the paramet ric 
drinking water limit of 0.1μg/L by several metabolites of DPX KE 459 
(flupyrsulfuron -methyl)  in situations represented by all pertinent groundwater 
scenarios.  
(9) Regardless of the classification proposed by the Authority, g iven the intrinsic 
toxicologica l properties of the parent substance shown in the studies, in particular in 
relation to carcinogenicity and reproductive toxicity,  the presence of the metabolites  in 
groundwater is of particular concern  since it has not  be demonstrated that these 
metabolites do not share the same intrinsic properties . Therefore it cannot currently be 
established that the presence of the metabolites in groundwater will not result in  
unacceptable effects on groundwater and  in harmful effec ts on human health .  
(10) Furthermore , the Authority concluded that the groundwater exposure assessment could 
not be finalised based on the available information for metabolite IN -JE127, the 
genotoxic potential of which cannot be excluded.  
(11) Given the uncertainty  about  the presence of th at metabolite in groundwater , 
unacceptable effects on groundwater and harmful effects on human health cannot 
currently be excluded.  
(12) Moreover,  the Authority concluded that there is a high risk  to aquatic organisms , in 
particular for  algae and aquatic plants,  from exposure to DPX KE 459 (flupyrsulfuron -
methyl) .  
(13) Based on these risks identified in recitals 9, 11 and 12 , it has not been established with 
respect to one or more representative uses of at least one plant protection product that 
                                                 
6 EFSA (European Food Safety Authority), 2014. Conclusion on the peer review of the pesticide risk assessment of 
the active substance flupyrsulfuron (variant e valuated flupyrsulfuron -methyl -sodium). EFSA Journal 
2014;12(11):3881, 86 pp. doi:10.2903/j.efsa.2014.3881 . 
7 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of subst ances and mixtures, amending and repealing Directives 67/548/EEC 
and 1999/45/EC, and amending Regulation (EC) No 1907/2006 ( OJ L  353, 31.12.2008, p.  1).  
EN 4   EN the approval criteria provided for in Article 4 of Regulation (EC) No  1107/2009  are 
satisfied. It is therefore appropriate not to re new the approval of  DPX KE 459 
(flupyrsulfuron -methyl)  in accordance with Article  20(1)(b) of that Regulation . 
(14) Given th e risks detailed in recital s 9, 11 and 12, the der ogation provided for in 
Article  4(7) of Regulation (EU) No 1107/2009 does not apply.  The application of that 
derogation is also excluded on the grounds that it has not been established that any of 
the criteria set out in points 3.6.3, 3.6.4, 3.6.5 or 3.8.2 of Annex II to Regulation (EU) 
No 1107/2009 are not satisfied.  
(15) 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 submitted its comments, which have been 
carefully examined.  
(16) However, de spite the arguments put forward by the applicant, the concerns related to 
the substance  could  not be eliminated.  
(17) Member States should be given  time to withdraw authorisations for plant protection 
products containing DPX KE 459 (flupyrsulfuron -methyl) . 
(18) For plant protection products containing DPX KE 459 (flupyrsulfuron -methyl) , where 
Member States grant any grace period in accordance with Article  46 of Regulation 
(EC) No  1107/2009, that period should, at the latest, expire on [publications office 
insert dat e 15 months from the date of entry into force].  
(19) This Regulation does not prejudice the submission of a further application for 
DPX  KE 459 (flupyrsulfuron -methyl) in accordance with  Article  7 of Regulation (EC) 
No 1107/2009.  
(20) 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 DPX KE 459 (flupyrsulfuron -methyl)  is not renewed .  
 
Article 2  
Amendments to Implementing Regulation (EU) No 540/2011  
In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 19 on DPX KE 
459 (flupyrsulfuron -methyl) is deleted.   
Article 3 
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
DPX  KE 459 (flupyrsulfuron -methyl)  as active substance by [Office of Publications please 
insert date 3 months from the date of entry into force ] at the latest .  
EN 5   EN Article 4 
Grace period  
A 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 by [insert date 15 months from the 
date of entry into force]  at the latest.   
Article  5 
Entry into force  
This Regulation shall enter into force on the twentieth 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 the Commission  
 The President  
 Jean -Claude JUNCKER