EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10978/2016 rev. 0  
[…](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 fluroxypyr  
(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 fluroxypyr  
(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 the second 
alternative of Article 21(3)  and Article 7 8(2) thereof , 
Whereas:  
(1) Commission Implementing Regulation (EU) No 736/20112 approved  fluroxypyr  as an 
active substance in accordance with Regulation (EC) No 1107/2009  subject to certain 
conditions requiring the Member States concerned to ensure that the applicant  at 
whose request fluroxypyr  was approved  provide further confirmatory information  on 
six points , one of which concerned the relevance of the impurities present in the 
technical specifications.   
(2) On 25 June 2012 and 5 September 2013  the applicant s ubmitted additional information 
intended to address the confirmatory data requirements to the rapporteur Member State 
Ireland within the time period provided for its submission . 
(3) Ireland assessed the additional information provided by the applicant. It subm itted its 
own 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 22 December  2014 and invited them to comment on the 
assessment . 
(4) The Authority published  a Technical Report3 summarising the outcome of this 
consultation  process for fluroxypyr on 22 July 2015 .  
(5) The draft assessment report, the addendum and the Technical Report were reviewed by 
the Member States and the Commission within the Standing Committee on Plants, 
Animals, Food and Feed and finalised on  23 March  2017  in the format of the 
Commission review report for fluroxypyr .  
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Implementing Regulation (EU) No  736/2011 of 26  July 2011 approving the active 
substance fluroxypyr, 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  (OJ L 195, 27.7.2011, p. 37 ). 
3 EFSA (European Food Safety Authority), 2015. Technical report on the outcome of the consultation 
with Member S tates, the applicant and EFSA on the pesticide risk assessment for fluroxypyr in light of 
confirmatory data . EFSA supporting publication 2015:EN -857. 43 pp.  EN 3   EN (6) The Commission invited the applicant to submit its comments on the Commission 
review report for fluroxypyr.  
(7) N-methyl -2-pyrrolidone  (NMP ) is classified under Regulation (EC) No 1272/2008  of 
the European Parliament and of the Council4 as toxic for reproducti on category 1B and 
has a general concentration limit of 0.3%. The presence of NMP in the technical 
material below 3 g/kg would be highly unlikely to pose any  risk to consumers.  Hence  
the Commission has concluded  that the additional  information provided sho wed that a 
maximum level for the toxicologically relevant impurity  NMP should be set at less 
than 3 g/kg (< 0.3%) in the technical material . 
(8) In order to ensure a high level of protection for consumers it is, therefore, appropriate 
to establish a  maximum level for this impurity in the commercially manufactured 
active substance .  
(9) The Annex to Implementing Regulation (EU) No 540/2011 should therefore be 
amended accordingly.  
(10) Member States should be allowed sufficient  time to amend or withdraw authori sations for 
plant protection products containing fluroxypyr . 
(11) For plant protection products containing fluroxypyr , where Member States grant any 
grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, th at 
period should, at the latest, e xpire on [insert date 15 months from the date of entry into 
force] . 
(12) 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 
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 Regulation.  
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 fluroxypyr  
as the active substance by [Office of Publications please insert date 3 months  from the date of 
entry into force ] at the latest.  
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 possible and shall expire by [Office of Publications please 
insert date 15  months from the date of entry into force] at the latest.   
                                                 
4 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on  
classification, labelling and packaging of substances and mixtures, am ending 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 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