EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10213/2018 rev 1  
[…](2018) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance quinoxyfen, 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 Commiss ion Implementing Regulation (EU) No 540/2011  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance quinoxyfen, 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 Commission Implementing Regulation (EU) No 540/2011  
(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 rep ealing Council Directives  79/117/EEC and 91/414/EEC1, and in particular 
Article  20(1) and Article  78(2) thereof,  
Whereas:  
(1) Commission Directive 2004/60/EC2 included quinoxyfen  as an active substance in 
Annex I to Council Directive 91/414/EEC3. 
(2) Active substa nces 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 quinoxyfen , as set out in Part  A of the Annex to 
Implementing Regulation (EU) No  540/2011, expires on 30 April  2019 . 
(4) An application for the renewal of the approval  of quinoxyfen  was submitted in 
accordance with Article  1 of Commission Implementing Regulation (EU) 
No 844/20125 within the time period provided for in that Article.  
(5) The applicant submitted the supplementary dossiers required in accordance with 
Article  6 of Regulation (EU) No  844/2012. The application was found to be complete 
by the rappo rteur Member State.  
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Directive 2004/60/EC of 23 April 2004 amending Council Directive 91/414/EEC to 
include quin oxyfen as active substance (OJ L 120, 24.4.2004, p.  39). 
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 amending 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). 
5 Commission Implementing Regulation (EU) No 844/2012 of 18 Septembe r 2012 setting out the 
provisions necessary for the implementation of the renewal procedure for active substances, as provided 
for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the 
placing of plant protection prod ucts 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 Food Safety 
Authority (‘the Authority’) and the Commission on 5 December  2016.  
(7) In acc ordance with  Article 11( 4) of Implementing Regulation (EC) No 844/2012, that 
assessment  was limited to a targeted assessment . The assessment did not go beyond  
the identity, methods of analysis, environmental fate and behavior and ecotoxicology 
information that related to the potential persistent bioaccumulative and toxic (PBT)  
properties , very persistent and very bioaccumulative (vPvB)  properties  and persistent 
organic pollutant (POP) properties of quinoxyfen , since  the approval criteria set out in 
point 3.7 .2 and 3.7.3  of Annex II to Regulation (EC) No 1107/2009  are not satisfied    
(8) The Aut hority communicated the renewal assessment report to the applicant and to the  
Member States for comments and forwarded the comments received to the 
Commission. The Authority also made the supplementary summary dossier available 
to the public.  
(9) On 24 Novermber 2017 the Authority communicated to the Commission its 
conclusion6 on whether quinoxyfen can be expected to meet the approval criteria 
provided for in Article  4 of Regulation (EC) No  1107/2009. The conclusion is limited 
to a hazard targeted assessment (focussed on the elements referred to in point 3.7 of 
Annex II to Regu lation (EC) No  1107/2009 ) and does not cover all the approval 
criteria. The Authority concluded that quinoxyfen is a PBT substance as well as a 
vPvB substance .   
(10) The Commission invited the applicant to submit its comments on the conclusion of the 
Authority  and, in accordance with the third subparagraph of Article 14(1) of 
Implementing Regulation (EC) No 844/2012, 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 related to 
the substance could not be eliminated.  
(12) Based on the concerns identified, it has not been established with respect to one or 
more representative uses of at least one plant protection product  containing 
quinoxyfen  that th e 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 
quinoxyfen in accordance with Article  20(1)(b) of that Regulation.  
(13) Member States should be provided  with s ufficient time to withdraw authorisations for 
plant protection products containing quinoxyfen.  
(14) For plant protection products containing quinoxyfen, 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, expire on [Office of Publications please insert date 
15 months from the date of entry into force] .  
(15) Commission Implementing Regulation (EU) 2018/5247 extended the expiry date of 
quinoxyfen to 30  April  2019 in order to allow the renewal process to be completed 
                                                 
6 EFSA (European Food Safety Authority), 2018. Peer review of the targeted hazard assessment of the 
pesticide active substance quinoxyfen. EFSA Journal 2018;16(1):5085 [11 pp.]. DOI: 
10.2903/j.efsa.2018.5085 . 
7 Commission Implementing Regulation (EU) 2018/524 of 28 March 2018 amending Implementing 
Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 
Bacillus subtilis (Cohn 1872) Strain QST 713, identical with s train AQ 713, clodinafop, clopyralid, 
cyprodinil, dichlorprop -P, fosetyl, mepanipyrim, metconazole, metrafenone, pirimicarb, Pseudomonas EN 3  EN before the expiry of the approval of that substance. Given that a decision has been 
taken ahead of this extended expiry date, this Regulation should apply as soon as 
possible . 
(16) This Regulation does not pre vent the submission of a further application for the 
approval of quinoxyfen pursuant to Article 7 of Regulation (EC) No 1107/2009.  
(17) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, A nimals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Non-renewal of approval of active substance  
The approval of the active substance quinoxyfen is not renewed.  
Article 2  
Amendments to Implementing Regulation (EU) No 540/2011  
In Part A of the Ann ex to Implementing Regulation (EU) No 540/2011, row 82, on 
quinoxyfen, is deleted.  
Article 3  
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
quinoxyfen as active substance by [ Office of Publication s please insert date 6  months from 
the date of entry into force ] at the latest.  
Article 4  
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 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.  
                                                                                                                                                         
chlororaphis strain: MA 342, pyrimethanil, quinoxyfen, rimsulfuron,  spinosad, thiacloprid,  
thiamethoxam, thiram, tolclo fos-methyl, triclopyr, trinexapac, triticonazole and ziram ( OJ L 88, 
4.4.2018, p.  4). EN 4  EN Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER