EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11753/2016  
[…](2016) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -approval of the active substance orthosulfamuron, 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  
(Text with EEA relevance)   EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning  the non -approval of the active substance orthosulfamuron, 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  
(Text with EEA relevance)  
THE EUROPEA N 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 ma rket 
and repealing Council Directives 79/117/EEC and 91/414/EEC1, and in particular 
Article  13(2) thereof,  
Whereas:  
(1) In accordance with Article 80(1)( a) of Regulation (EC) No 1107/2009, Council 
Directive 91/414/EEC2 is to apply, with respect to the procedur e and the conditions for 
approval, to active substances for which a decision has been adopted in accordance 
with Article  6(3) of that Directive before 14  June 2011. For orthosulfamuron  the 
conditions  of Article 80(1)(a) of Regulation (EC) No  1107/2009 are fulfilled by 
Commission Decision 200 6/806/EC3.  
(2) In accordance with Article  6(2) of Directive  91/414/EEC  Italy received on 4 July 2005 
an application from Isagro S.p.A.  for the inclusion of the active substance  
orthosulfamuron  in Annex I to Di rective 91/414/EEC. Decision  2006 /806/EC 
confirmed that the dossier was ‘complete’ in the sense that it could be considered as 
satisfying, in principle, the data and information requirements of Annexes  II and III to 
Directive  91/414/EEC .  
(3) For that active substance, the effects on human and animal health and the environment 
have been assessed, in accordance with the provisions of Article  6(2) and (4)  of 
Directive  91/414/EEC, for the use s proposed by the applicant. The designated 
rapporteur Member State subm itted a draft assessment report on  27 July 2012.  In 
accordance with Article 6(3) of Commission Regulation (EU) No  188/20114 additional 
information was requested from the applicant . The evaluation by Italy of the additional 
information submitted by the appl icant  was submitted in the format of addenda to the 
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 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).  
3 Commission Decision 200 6/806/EC of 2 4 Novem ber 200 6 recognising in principle the completeness of 
the dossier submitted for detailed examination in view of the possible inclusion of orthosulfamuron in 
Annex I to Council Directive 91/414/EEC  (OJ L 329, 25.11. 2006, p. 74).  
4 Commission Regulation (EU) No 188/ 2011 of 25 February 2011 laying down detailed rules for the 
implementation of Council Directive 91/414/EEC as regards the procedure for the assessment of active 
substances which were not on the market 2 years after the date of notif ication of that Directiv e 
(OJ L 53, 26.2.2011, p. 51) . EN 3   EN draft assessment report and compiled by the European Food Safety Authority  
(hereinafter 'the Authority')  in August  2013 . 
(4) The draft assessment report was reviewed by the Member States and the Authority . 
The Authority presented to the Commission its conclusion on the pesticide risk 
assessment of the active substance orthosulfamuron5 on 3 September  2013. The 
Authority concluded that  the information available on the nature of residues in primary 
and succeeding crops in combination with a lack of toxicological information and 
intake assessment on some plant metabolites does not allow finalising  the assessment 
of the consumer risk.  In ad dition, also the risk assessment to soil dwelling organisms 
and aquatic organisms could not be finalised. Moreover , the Authority identified 
concerns from some metabolites, and consequently the exposure assessment to 
groundwater could not be finalised.  
(5) The Commission invited the applicant to submit its comments  on the conclusion of the 
Authority , and, in accordance with Article 9(1) of Regulation (EU) No 188/2011 on 
the draft review report. The applicant submitted its comments, which have been 
carefully exa mined.  
(6)  However, despite the arguments put forward by the applicant, the concerns 
identified /referred to in  recital 4  could not be eliminated . 
(7) Consequently it has not been demonstrated that it may be expected that, under the 
proposed conditions of use, pla nt protection products containing orthosulfamuron  
satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 
91/414/EEC.  
(8) Orthosulfamuron should therefore not be approved  pursuant to Article 13(2) of 
Regulation (EC) No 1107/2009 . 
(9) In accordance with Article  8(1)(b) of Directive  91/414/EEC , Member States were 
given the possibility to grant provisional authorisations for plant protection products 
containing orthosulfamuron  for an initial period of three years . Commission  
Implementing  Decision  2013/205/EU6 allowed Member States to extend provisional 
authorisations for orthosulfamuron for a period ending on 30  April  2015 at the latest.  
(10) As all existing authorisations have expired, it is not necessary to provide an additional 
period  to w ithdraw authorisations for plant protection products containing  
orthosulfamuron.   
(11) This Regulation does not prejudice the submission of a further application for 
orthosulfamuron  in accordance with Article  7 of Regulation (EC) No  1107/2009 .  
(12) The measures pro vided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed , 
 
                                                 
5 EFSA Journal 2013;11( 9):3352. Available online: www.efsa.europa.eu . 
6 Commission Implementing Decision 201 3/205/EU of 25 April  2013 allowing Member States to extend 
provisional authorisations granted for the new active substances acequinocyl, aminopyralid, ascorbic 
acid, flubendiamide, gamma -cyhalothrin, ipconazole, metaflumizone, orthosulfamuron, Pseudomonas 
sp. strain DSMZ 13134, pyridalil, pyroxsulam, spiromesifen, thiencarbaz one and topramezone 
(OJ L 117, 27.4.2013, p. 2 0). EN 4   EN HAS ADOPTED THIS REGULATION:  
Article 1  
Non-approval of active substance  
The active substance orthosulfamuron is not approved.  
Article 2  
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