EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10984/2016 rev. 1  
[…](2016) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending Implementing Regulation (EU) No 540/2011 as regards the conditions of 
approval of the active substance oxyfluorfen  
(Text with EEA relevance)    
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending  Implementing Regulation (EU) No 540/2011 as regards the conditions of 
approval of the active substance oxyfluorfen  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Re gulation (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 the second 
alternat ive of Article  21(3)  and Article 78(2) thereof , 
Whereas:  
(1) Commission Implementing Regulation (EU) No 798/20112 approved  oxyfluorfen  as 
an active substance in accordance with Regulation (EC) No 1107/2009 , under the 
condition that the Member States concerned ensure that the applicant  at whose request 
oxyfluorfen was approved  provides further confirmatory information  on five specific 
aspects , one  of which concerned the  potential risk to aquatic organisms fo r the active 
substance and for the metabolites RH -45469, MW 306, MW 347, MW 274 and the 
unidentified metabolite Deg 27.  
(2) On 29 June and 15 December 2012  the applicant submitted additional information to 
address the confirmatory data requirements to the rapp orteur Member State  Spain  
within the time period provided for its submission.  
(3) Spain assessed the additional information submitted by the applicant. It submitted its 
assessment, in the form of an addendum  to the draft assessment report, to the other 
Member States, the Commission and the European Food Safety Authority, hereinafter 
‘the Authority’, on 14 July 2014.  
(4) The Member States, the applicant and the Authority were consulted and asked to 
provide comments on the assessment of the rapporteur Member State. The Authority 
published a Technical Report summarising the outcome of this consultation for 
oxyfluorfen on 6 November 20143. 
(5) The Commission consulted the Authority in relation to certain areas of the assessment. 
The Authority presented its conclusion  on th e risk assessment of oxyfluorfen on 28 
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Implementing Regulation (EU) No  798/2011 of 9  August 2011 approving the active 
substance oxyfluorfen, 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 the 
Annex to Commission Implementing Regulation (EU) No  540/2011 and Commission Decision 
2008/934/EC . (OJ L 205, 10.8.2011, p. 9) . 
3 EFSA (European Food Safety Authority), 201 4. Technical report on the outcome of the consultation 
with Member States, the applicant and EFSA on the pesticide risk assessment of confirmatory data  for 
oxyfluorfen . EFSA supporting publication 2014:EN -686. 40  pp.  
EN 3   EN July 20154. The draft assessment report, the addendum and the conclusion  of the 
Authority were reviewed by the Member States and the Commission within the 
Standing Committee on Plants, Animals, Food and Feed  and final ised on 24 January  
2017 in the format of the Commission review report for oxyfluorfen .  
(6) The Commission invited the applicant to submit its comments on the review report for 
oxyfluorfen.  
(7) The Commission has co nsidered  that the additional information provided showed that 
parent substance and metabolites MW 347 and Deg 27  represent a high risk for aquatic 
organisms . 
(8) The Commission has concluded that the further confirmatory information required has 
not been fully provided and that a high risk for aquati c organisms  resulting from 
exposure to oxyflurofen  and metabolites MW 347 and Deg  27 cannot be excluded 
except by imposing further restrictions.  
(9) In order to minimise the exposure of aquatic organisms, it is, therefore , appropriate to 
further  restrict the c onditions  of use of this active substance and to provide for specific 
risk mitigation measures for the protection of those species.  
(10) The Annex to Implementing Regulation (EU) No 540/2011 should therefore be 
amended accordingly.  
(11) Member States should be provided with time to amend or withdraw authorisations for 
plant protection products containing oxyfluorfen.  
(12) For plant protection products containing oxyfluorfen , 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 [Office of Publications please insert date 15  months from 
the date of entry into force] . 
(13) The measures provided for in this Regulation are in accordance with the opinion of th e 
Standing Committee on Plants, Animals, Food and Feed , 
 
HAS ADOPTED THIS REGULATION:  
Article 1 
Amendment to Implementing Regulation (EC) No 540/2011  
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the 
Annex to this Regu lation.  
Article 2  
Transitional measures  
Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary 
amend or withdraw existing authorisations for plant protection products containing 
oxyfluorfen  as active substance by [Office of Publications please insert date 3 months from 
the date of entry into force ] at the latest . 
                                                 
4 Conclusion on the peer review of the pesticide risk assessment for the active substance oxyfluorfen in 
light of confirmatory data . EFSA Journal 2015; 13(8): 4205, 45 pp. doi: 10.2903/j.efsa. 2015/4205 .   
EN 4   EN Article 3 
Grace period  
Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) 
No 1107/2009 shall be as short as possibl e and shall expire by [Office of Publications please 
insert date 15  months from the date of entry into force] at the latest.   
Article 4 
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