EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10234/2020  
[…](2020) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the approval of the active substance benfluralin, 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 th e Annex to Commission Implementing Regulation (EU) No 540/2011  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the approval of the active substance benfluralin, 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  
(Text with EEA relevance)  
THE E UROPEAN 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  79/11 7/EEC and 91/414/EEC1, and in particular 
Article  20(1)   and Article 78(2) thereof,  
Whereas:  
(1) Commission Directive 2008/108 /EC2 included benfluralin  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 substance benfluralin , as set out in Part A of the Annex to 
Implementing Regulation (EU) No 540/2011 , expires on 28 February  2021 . 
(4) An application for the renewal of the approval of the active substance benfluralin  was 
submitted in accordance wit h Article 1 of Commission Implementing Regulation (E U) 
No 844/20125 within the time period provided for in that Article.  
(5) The applicant s 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 2008/108/EC of 26 November 2008 amending Council Directive 91/414/EEC to 
include flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat as active substances (OJ L 317, 
27.11.2008, p. 6 ). 
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 Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation 
(EC) No 1107/2009 of the European Parliament and of the Counci l as regards the list of approved active 
substances (OJ L 153, 11.6.2011, p.  1). 
5 Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the 
provisions necessary for the implementation of the renewal procedure for active subs tances, as provided 
for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the 
placing of plant protection products on the market  (OJ L 252, 19.9.2012, p.  26). EN 2  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 Foo d Safety 
Authority ( ‘the Aut hority’) and the Commission on 28 August  2017 . 
(7) The Authority made the supplementary summary dossier available to the public. The 
Authority also circulated the renewal assessment report to the applicant s and to the 
Member States for comments and launched a pu blic consultation on it. The Authority 
forwarded the comments received to the Commission.  
(8) On 27 September  2019,  the Authority communicated  to the Commission its 
conclusion6 on whether benfluralin  can be expected to meet the approval criteria 
provided for i n Article 4 of Regulation (EC) No  1107/2009.  
(9) The Authority identfied a number of concerns. In particular  it concuded that  a long -term 
risk to birds and mammals including the risk from secondary poisoning of earthworm -
eating birds and mammals was identified  as a critical area of concern.  Furthermore, the 
Authority concluded on the presence of a long -term risk to aquatic organisms from 
benfluralin , even when applying mitigation measures and a long-term risk to aquatic 
organisms caused by the metabolites  371R and 372R  . Finally, The genotoxic potential of 
an impurity cannot be excluded since the technical specificat ion, including the level of 
that impurity, was not supported by the toxicological ass essment . 
(10) The Commission invited the applicant to submit its com ments on the conclusion of the 
Authority. Furthermore, in accordance with the third subparagraph of  Article  14(1) of 
Implementing Regulation (EU) No  844/2012, the Commission invited the applicant to 
submit comments on the renewal report. The applicant submitted its comments, which 
have been carefully examined.  
(11) However, despite the arguments put forward by the applicant, the concerns regarding 
the active substance  could not be eliminated.  
(12) 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  1107/2009 are satisfied. It is therefore appropriate not 
to renew the approval of the active substance benfluralin . 
(13) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly.  
(14) Member States should be given  sufficient  time to withdraw authorisations for plant 
protection products containing benfluralin.  
(15) For plant protection products containing benfl uralin , 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 
12 months from the date of entry into force  of this Re gulation. ].  
(16) Commission Implementing Regulation (EU) 20 19/20947 extended until 28 
February  2021 the period of approval of benfluralin  in order to allow the renewal 
                                                 
6 EFSA. 2019. Conclusion on the peer review of the pestici de risk assessment of the active substance 
benfluralin. EFSA Journal 2019;17(10):5842 . 34 pp. doi:10.2903/j.efsa.2019.5842 . 
7 Commission implementing Regulation (EU) 2019/2094 of 29 November 2019 amending Implementing 
Regulation (EU) No 540/2011 as regards  the extension of the approval periods of the active substances 
benfluralin, dimoxystrobin, fluazinam, flutolanil, mancozeb , mecoprop -P, mepiquat, metiram, oxamyl 
and pyraclostrobin ( OJ L 317, 9.12.2019, p. 102).  EN 3  EN process to be completed before the expiry of the approval period of that substance. 
Given that a decision on the non -renewal of the approval has been taken ahead of that 
extended expiry date, this Regulation should apply as soon as possible.  
(17) This Regulation does not prevent  the submission of a further application for the 
approval of benfluralin  pursuant to  Article  7 of Regulation (EC) No  1107/2009.  
(18) The measures provided for in this Regulation are in accordance with the opinion of the  
Standing Committee on Plant s, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Non-renewal of the approval of the active substance  
The approval of the active substance benfluralin  is not renewed.   
Article 2 
Amendment  to Implementing Regulation (EU) No 540/2011  
In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 188 on 
benfluralin , is deleted.  
Article 3  
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
benfluralin  as an active substance by  [Office of Publications please insert date 6 months from 
the date of entry into force ]. 
Article 4  
Grace period  
Any grace period granted by Member States  in accordance with Article 46 of Regulation (EC) 
No 1107/2009 shall expire by  [Office of Publications please insert date 12 months  from the 
date of entry into force] . 
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.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN  