EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10885/2017 rev. 1  
[…](2017) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance oxasulfuron, 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 Implem enting 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 oxasulfuron, 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 Regulation (EU) No 540/2011  
(Text with EEA relevance)  
THE EUROPEAN COMMI SSION,  
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) (b) and Article 78(2) thereof , 
Whereas:  
(1) Commission Directive 2003/23/EC2 included oxasulfuron 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 subs tance oxasulfuron , as set out in Part A of the Annex to 
Implementing Regulation (EU) No 540/2011 expires on 31 July 2018 . 
(4) An application for the renewal of the approval of oxasulfuron  was submitted in 
accordance with Article 1 of Commission Implementing Regulation (EU) 
No 844/20125 within the time period provided for in that Article.  
(5) The applicant submitted the supplementary dossiers required in accordance with 
Article  6 of Implementing Regulation (EU) No  844/2012. The application was found 
to be complete by  the rapporteur Member State.  
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Directive 2003/23/EC of 25 March 2003 amending Council Directive 91/414/EEC to 
include imazamox, oxasulfuron, ethoxysulfuron, foramsulfuron, oxadiargyl and cyazofamid as active 
substances  (OJ L 81, 28.3.2003, p. 39).  
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 Commi ssion 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 R egulation (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 concer ning the 
placing of plant protection products on the market  (OJ L 252, 19.9.2012, p. 26 ).  
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 (‘the Authority’ ) and the Commission on 29 January  2016 . 
(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 2 February 2017  the Authority communicated to the Commission its conclusion6 
on whether oxasulfuron  can be expected to meet the approval criteria provided for in 
Article  4 of Regulation (EC) No 1107/2009.  
(9) The Authority identified a large number of data  gaps resulting in the inability to finalise 
the risk assessment in several  areas . In particular, the available information on 
oxasulfuron and its metabolites did not allow finalising the assessment of the overall 
consumer exposure, the groundwater exposur e, the risk to aquatic organisms , 
earthw orms, soil macro - and microorganisms and non -target terrestrial plants.  
(10) The Commission presented the draft renewal report and a draft Regulation for  
oxasulfuron to the Standing Committee on Plants, Animals, Food and Feed on 
19 July 2017.  
(11) The Commission invited the applicant to submit its comments on the conclusion of the 
Authority. Furthermore, in accordance with the third subparagraph of Article 14 (1) of 
Implementing Regulation (E U) No 844/2012, the Commission invited the applicant to 
submit comments on the draft renewal report. The  applicant submitted its comments, 
which have been carefully examined.  
(12) However, despite the arguments put forward by the applicant, the concerns referred  to 
in recital  9 could not be eliminated.  
(13) 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 1107/20 09 are satisfied. The approval of the active 
substance oxasulfuron  should therefore not be renewed.  
(14) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly.  
(15) Member States should be allowed sufficient time to withdraw authorisations  for plant 
protection products containing oxasulfuron . 
(16) For plant protection products containing oxasulfuron , where Member States grant any 
grace period in accordance with Article  46 of Regulation (EC) No  1107/2009, t hat 
period should , at the latest,  expire  on [Office of Pub lications please insert date 
15 months from the date of entry into force ]. 
(17) Commission Implementing Regulation (EU) 2017/8417 extended the expiry date of 
oxasulfuron  to 31 July 2018  in order to allow the renewal process to be completed 
                                                 
6 EFSA Journal 2017;15(2):4722, 33 p p. doi:10.2903/j.efsa.2017.4722. Available online: 
www.efsa.europa.eu . 
7 Commission Impl ementing Regulation (EU) 2017/841 of 17 May 2017 amending Implementing 
Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 
alpha -cypermethrin, Ampelomyces quisqualis strain: aq 10, benalaxyl, bentazone, bif enazate, 
bromoxynil, carfentrazone ethyl, chlorpropham, cyazofamid, desmedipham, diquat, DPX KE 459 
(flupyrsulfuron -methyl), etoxazole, famoxadone, fenamidone, flumioxazine, foramsulfuron,  
EN 4  EN before the expiry of the approval of that substance. Given that a decision is taken 
ahead of that extended expiry date, this Regulation should apply as soon as possible.  
(18) This Regulation does not prejudice the submission of a further application for the 
approval of oxasulfuron  in accordance with  Article  7 of Regulation (EC) 
No 1107/2009.  
(19) 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 oxasulfuron  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 42 on 
oxasulfuron, is deleted.  
Article 3 
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
oxasulfuron  as active substance by [ Office of Publications please insert date 3 months from 
the date of entry into force ] at the latest.  
Article 4 
Grace period  
Any grace period granted by Member States in accordance with Article 20 of Regulation (EC) 
No 1107/2009 sha ll be as short as possible and shall expire by [Office of Publications please 
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.  
                                                                                                                                                         
Gliocladium catenulatum strain: j1446, imazamox, imazosulfuron, iso xaflutole, laminarin, metalaxyl -m, 
methoxyfenozide, milbemectin, oxasulfuron, pendimethali n, phenmedipham, pymetrozine, 
s-metolachlor, and trifloxystrobin (OJ L 125, 18.5.2017, p. 12 –15).  
EN 5  EN Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER