EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10294/2018 rev 1  
[…](2018) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
renewing the approval of the active substance methoxyfenozide, as a candidate for 
substitution, 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)    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
renewing the approval of the active substance methoxyfenozide, as a candidate for 
substitution, 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 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 p lant protection products on the market 
and repealing Council Directives  79/11 7/EEC and 91/414/EEC1, and in particular Article  24 
in conjunction with Article 20(1) thereof,  
Whereas:  
(1) Commission Directive 2005/3/EEC2 included methoxyfenozide  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 Imple menting Regulation (EU) No  540/20114. 
(3) The approval of the active substance methoxyfenozide, 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 methoxyfeno zide was submitted in 
accordance with Article  1 of Commission Implementing Regulation (E U) 
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 Impleme nting 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 2005/3/EC of 19 January 2005  amending Council Directive 91/414/EEC to 
include imazosulfuron, laminarin, methoxyfenozide and s -metolachlor as active substances  (OJ L 20, 
22.1.2005 p.  19). 
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  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 Europea n Foo d Safety 
Authority ( ‘the Aut hority’) and the Commission on 4 August  2016 . 
(7) The Authority 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.  
(8) On 10 August 2017 t he Authority communicated  to the Commission its conclusions6 
on whether methoxyfenozide can be expected to meet the approval criteria provided 
for in Article  4 of Regulation (EC) No  1107/2009. The Commission presented the draft 
renewal report for methoxyfenozide  to the Standing Committee on Plant s, Animals, 
Food an d Feed  on 25 May 2018.  
(9) The applicant was given the opportunity to submit comments on the draft renewal 
report.  
(10) It has been established with respect to one or more representative uses of at least one 
plant protection product containing methoxyfenozide that the approval criteria 
provided for in Article  4 of Regulation (EC) No  1107/2009 are satisfied. It is therefore 
appropriate to renew the approval of methoxyfenozide.  
(11) The risk assessment for the renewal of the approval of methoxyfenozide is based on a 
limite d number of representative uses, which however do not restrict the uses for 
which plant protection products containing methoxyfenozide may be authorised. It is 
therefore appropriate to remove the restriction for use only as an insecticide.   
(12) The Commission , however , considers that methoxyfenozide is a candidate for 
substitution pursuant to Article 24 of Regulation (EC) No 1107/2009. 
Methoxyfenozide is a persistent and toxic substance in accordance with points 3.7.2.1 
and 3.7.2.3 respectively, of Annex II to Regulation (EC) No 1107/2009, given that the 
half-life in soil and water is greater than 120 days and the long -term no -observed 
effect concentration for freshwater organisms is less than 0.01 mg/L. Methoxyfenozide 
therefore fulfils the condition set in the  second indent of point 4 of Annex II to 
Regulation (EC) No 1107/2009.  
(13) It is therefore appropriate to renew the approval of methoxyfenozide as a candidate for 
substitution  pursuant to Article 24 of Regulation (EC) No 1107/2009.  
(14) In accordance with Article  14(1) of Regulation (EC) No  1107/2009 in conjunction 
with Article  6 thereof, and, in the light of current scientific and technical knowledge, it 
is, however, necessary to include certain conditions and restrictions. It is, in particular, 
appropriate to rest rict the use of plant protection products containing methoxyfenozid e 
on fruiting vegetables of solanace ae in greenhouses in order to  minimise the exposure 
for groundwater and not target organisms and to require fu rther confirmatory 
information.   
(15) The Annex to Implementing Regulation (EU) No  540/2011 should therefore be 
amended accordingly.  
(16) Commission Implementing Regulation (EU ) No 2018/ 9177 extended  the approval 
period of methoxyfenozide to 31  July 2019 in order to allow the renewal process to be 
                                                 
6 EFSA Journal 2017;15(9):4978  
7 Commission Implementing Regulation (EU) 2018/ 917 of 27 June 2018 amending Impleme nting 
Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances  
EN 3  EN completed before the expiry of the approval of that substance. However, given that a 
decision on renewal has been taken ahead of this extended expiry date, this Regulation 
should apply from 1  February  2019 .  
(17) The measures provided for in this Regulation are in accord ance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Renewal of the approval of the active substance as a candidate for substitution  
The approval of the active substance methoxyfenozide , as a candidate for substitution, is 
renewed as set out in Annex  I. 
Article 2  
Amendments to Implementing Regulation (EU) No 540/2011  
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with 
Annex  II to this Regulation.  
Article 3 
Entry into force and date of application  
This Regulation shall enter into force on the third  day following that of its publication in the 
Official Journal of the European Union . 
It shall apply from 1 February 2019 . 
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  
                                                                                                                                                         
alpha -cypermethrin, beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, 
carvone, chlorpropham, cyazofamid, desmediph am, dimethoate, dimethomorph, diquat, ethephon, 
ethoprophos, etoxazole, famoxadone, fenamidone, fenamiphos, flumioxazine, fluoxastrobin, folpet, 
foramsulfuron, formetanate, Gliocladium catenulatum  strain: J1446, isoxaflutole, metalaxyl -m, 
methiocarb, metho xyfenozide, metribuzin, milbemectin, oxasulfuron, Paecilomyces lilacinus  strain 251, 
phenmedipham, phosmet, pirimiphos -methyl, propamocarb, pro thioconazole, pymetrozine and 
s-metolachlor  (OJ L 163, 28.6.2018, p. 13 ).