EN   EN 
 
 
   
Brussels, XXX  
SANTE/10183/2018 rev 1  
[…](2018) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance etoxazole, 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 
Commissi on Implementing Regulation (EU) No 540/2011  
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission.  
Any views expressed are the preliminary views of the Commission services  
and may not in any circumstances be regarded as stating an official position  
of the Commission. The information transmitted is intended only for the  
Member State or entity to which it is addressed for discussions and may  
contain confidential and/or privile ged material.    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance etoxazole, 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 COMMI SSION,  
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 
Article  20(1) and Article  78(2) thereof,  
Whereas:  
(1) Commission Directive 2005/34/EC2 included etoxazole  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 etoxazole , as set out in Part  A of the Annex to 
Implementing Regulation (EU) No  540/2011, expires on 31 July 2019 . 
(4) An application for the renewal of the approval of etoxazole was submitted in 
accordance with Article  1 of Commission Implementing Regulation ( EU) 
No 844/20125within 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 rapporteur Member State.  
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Directive 2005/34/EC of 17 May 2005 amending Council Directive 91/414/EEC to 
include etoxazole and tepraloxydim as active substances (OJ L 125, 18.5.2005, p. 5).  
3 Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant prot ection 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 September 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 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 Food Safety 
Authority (‘the Authority’) and the Commission on 20 September  2016 . 
(7) The Authority com municated 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.  
(8) On 12 September 2017 the Authority communicated to the Commission its 
conclusion6 on whether etoxazole can be expected to meet the approval criteria 
provided for in Article  4 of Regulation (EC) No  1107/2009. The Authority concluded 
that the consumer dietary risk assessment couldn’t  be finalised because of the 
outstanding data to conclude on the residue definition for risk assessment for 
processed commodities and the fate of persistent soil metabolites in rotational crops. 
The Authority also concluded that there is a high risk t o aquatic invertebrates for all 
representative uses, a high risk for non -target arthropods for all representative uses 
evaluated and , in particular, a high risk for soil mites for representative uses in tomato, 
cucurbit, ornamentals, pome/stone fruit, grap es, strawberry and cotton.  Furthermore, 
etoxazole is a bioaccumulative and toxic  substance  in accordance with point  3.7.2.2 and 
point 3.7.2.3 of Annex  II to Regulation (EC) No  1107/2009.  
(9) The Commission invited the applicant to submit its comments on the co nclusion of the 
Authority and, in accordance with the third subparagraph of Article  14(1) of 
Implementing Regulation (EC) No  844/2012, on the draft renewal report.  The 
applicant submitted its comments, which have been carefully examined.  
(10) However, despite t he arguments put forward by the applicant, the concerns related to 
the substance could not be eliminated.  
(11) Consequently , it has not been established with respect to one or more representative 
uses of at least one plant protection product containing etoxazo le, 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 etoxazole  in 
accordance with Article  20(1)(b) of that Regulation.  
(12) Member States should be given  sufficient time to withdraw authorisations for plant 
protection products containing etoxazole . 
(13) For plant protection products containing etoxazole , where Member States grant any 
grace period in accordance with Article  46 of Reg ulation (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] .  
(14) Commission Implementing Regulation (EU) XXX7 extended the expiry date of 
etoxazole  to 31 July 2019  in order to allow the renewal process to be completed before 
                                                 
6 EFSA (European Food Safety Authority), 2017. Conclusion on the peer review of the p esticide risk 
assessment of the active substance etoxazole. EFSA Journal 2017;15(10):4988 [27 pp.]. doi: 
10.2903/j.efsa.2017.4988.  
7 Commissi on Implementing Regulation (EU ) …/…  of XXX  amending Implementing Regulation (EU) 
No 540/2011 as regards the extensi on of the approval periods of the active substances alpha -
cypermethrin, Ampelomyces quisqualis  strain: AQ 10, beflubutamid, benalaxyl, benthiavalicarb, 
bifenazate, boscalid, bromoxynil, captan, carfentrazone ethyl, carvone, chlorpropham, cyazofamid, 
desmed ipham, dimethoate, dimethomorph, diquat, ethephon, ethoprophos, etoxazole, famoxadone, 
fenamidone, fenamiphos, flumioxazine, fluoxastrobin, folpet, foramsulfuron, formetanate, Gliocladium 
catenulatum  strain: J1446, isoxaflutole, metalaxyl -m, methiocarb, me thoxyfenozide, metribuzin,  
EN 3  EN 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 . 
(15) This Regulation does not prevent  the submission of a further application for the 
approval of etoxazole  pursuant to Article 7 of Regulation (EC) No 1107/2009.  
(16) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, An imals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Non-renewal of approval of active substance  
The approval of the active substance etoxazole  is not renewed.  
Article 2  
Amendments to Implementing Regulation (EU) No 540/2011  
In Part A of the Annex  to Implementing Reg ulation (EU) No 540/2011, row 99 , on etoxazole , 
is deleted.  
Article 3  
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
etoxazole  as active substance by [Office of Publications pl ease 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.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER  
                                                                                                                                                         
milbemectin, oxasulfuron, Paecilomyces lilacinus  strain 251, phenmedipham, phosmet, pirimiphos -
methyl, propamocarb, prothioconazole, pymetrozine, s -metolachlor and trifloxystrobin (OJ L...., p. ).