EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10317/2017  
[…](2017) 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 bifenthrin  
(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 bifenthrin  
(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 I mplementing Regulation (EU) No 582 /20122 approved bifenthrin  as an 
active substance in accordance with Regulation (EC) No 1107/2009  and required the 
applicant at whose request bifenthrin  was approved  to provide inter alia  confirmatory 
information on the residual toxicity for non -target arthropods  and the ir potential for 
recolonization  and a monitoring programme to assess the potential for 
bioaccumulation and biomagnification in the aquatic and terrestrial environment . 
(2) On 2 9 July 2013 the applicant submitted the monitoring programme and the results 
hereof on 31 July 2015 . On 29 July 2014  the applicant submitted  the additional 
information to address the other confirmatory data requirements . These three 
submissions were  provid ed to the Rapporteur Member State France within the time 
period provided for their submission.  
(3) France assessed the additional information and the monitoring programme 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 (‘the Authority’ ), on 17 December  2014 , as regards the 
additional information submitted to address the other confirmatory data requirements , 
and on 3 November  2015  as regards the monitoring programme.  
(4) Those other  Member States, the applicant and the Authority were consulted and asked 
to provide comments on the as sessment of the rapporteur Member State. The 
Authority published  the technical report s summarising the outcome of th e consultation 
for bifenthrin  on 26 March  20153 as regards the additional information to address the 
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Implementing Regulation (EU) No  582/2012 of 2 July 2012 approving the active 
substance bifenthrin , 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 173 , 3.7.2012 , p. 3). 
3 EFSA (European Food Safety Authority), Technical report on the outcome of the consultation with 
Member States, th e applicant and EFSA on the pesticide risk assessment of confirmatory data  for 
bifenthrin . EFSA supporting publication 201 5:EN-780. 23 pp.  
EN 3   EN other confirmatory data requirements and on 14 April  20164 as regards the monitoring 
programme.   
(5) The draft assessment report, the addendum and the technical report s of the Authority 
were reviewed by the Member States and the Commission within the Standing 
Committee on Plants, Animals, Food and Feed  and finalised on […] 2017  in the 
format of the Commission review report for bifenthrin . The Commission invited the 
applicant to submit its comments on the review report for bifenthrin . The applicant 
submitted its comments which have been carefully exa mined.  
(6) The Commission has come to the conclusion that the information submitted is 
insufficient and does not allow to conclude that adequate recolonization of certain 
species of non-target arthropods  in-field takes place while other possibilities of 
mitigation of such risk cannot realistically be implemented . In addition, the monitoring 
programme leaves uncertainty on whether its results, based on a superposition of 
mitigation techniques, are representative for agricultura l practise and sufficient to 
assess the potential for bioaccumulation and biomagnification in the aquatic and 
terrestrial environment . 
(7) Therefore, in order to preclude the identified high risk for non-target arthropods  and 
also to take into consider ation  the potential  of bioaccumulation and biomagnification 
in the aquatic and terrestrial environment , it is appropriate to further  restrict the 
conditions  of use of bifenthrin  and to only authorise applications in greenhouses with a 
permanent structure . 
(8) The Annex to Commission Implementing Regulation (EU) No 540/20115 should 
therefore be amended accordingly.  
(9) Member States should be allowed sufficient time to amend or withdraw authorisations 
for plant protection products containing bifenthrin . 
(10) For plant pr otection products containing bifenthrin , where Member States grant any 
grace period pursuant to  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 e ntry into force] . 
(11) 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 ( EU) No 540/2011  
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the 
Annex to this Regulation.  
                                                 
4 EFSA (European Food Safety Authority), Technical report on the outcome of the consultation with 
Member States, the applicant and EFSA on the pesticide risk assessment of confirmatory data for 
bifenthrin. EFSA supporting publication 201 6:EN-1019 . 39 pp. 
5 Commission 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).  
  
EN 4   EN 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 bifenthrin  
as active substance by [Office of Publications please insert date 3 months fr om 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.   
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