EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10318/2020 
(POOL/E4/2020/10318/10318 -EN.docx)  
[…](2020) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
renewing the approval of the active substance etoxazole 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 2  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
renewing the approval of the active substance etoxazole 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 relev ance)  
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 Article 
20(1)  in conjunction with Article 24(1) 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 Imple menting 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 2021 . 
(4) An application for the  renewal of the approval of the active substance  etoxazole  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 
Artic le 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 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 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 3  EN (6) The rapporteur Member State prepared a  draft renewal assessment report in 
consultation with the co -rapporteur Member State and submit ted it to the European 
Food Safety Authority ( ‘the Aut hority’) and the Commission on 20 September  2016 . 
(7) The Authority made the supplementary summary dossier available to the public. The 
Authority also circulated the draft renewal assessment report to the applicant and to 
the Member States for comments and launched a public consultation on it. The 
Authority forwarded the comments received to the Commission.  
(8) On 12 September 2017 , the Authority communicated  to the Commission its 
conclusion6 on whether etoxazo le can be expected to meet the approval criteria 
provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented  
a renewal report and the draft Regulation  for etoxazole  on 21 March  2018  and a revised 
version of the renewal report in March 2020 to the Standing Committee on Plant s, 
Animals, Food and Feed  . 
(9) As regards the criteria to identify endocrine disrupting properties introduced by 
Commission Regulation (EU) 2018/6057, the conclusion o f the Authority indicates  
that, based on the scientific evidence, it is highly unlikely that etoxazole  is an 
endocrine disrupter  via the estrogenic, androgenic and  thyroidogenic modalities. 
Furthermore, the available evidence indicates that etoxazole  is un likely to be an 
endo crine disruptor via the steroidogenic  modality.  Thus, the Commission concludes  
that etoxazole  is not to be considered as having endocrine disrupting properties.  
(10) The Commission invited the applicant to submit its comments on the conclusi on of the 
Authority and, in accordance with the third paragraph of Article 14(1) of 
Implementing Regulation (EU) No 844/2012, on the renewal report. The applicant 
submitted its comments  on both versions of the renewal report , which have been  
carefully examined . 
(11) It has been established with respect to one or more representative uses of at least one 
plant protection product containing the active substance etoxazole  that the approval 
criteria provided for in Article 4 of Regulation (EC) No  1107/ 2009 are satisfied.  
(12) The Commission , however, considers that  etoxazole  is a candidate for substitution 
pursuant to Article 24 of Regulation (EC) No 1107/2009. Etoxazole is considered a 
bioaccumulative  and toxic substance in accordance with points  3.7.2. 2 and the first 
sub point of 3.7.2.3  of Annex II to Regulation (EC) No  1107/2009 . Etoxazole  
therefore fulfils the condition set in the second indent of point  4 of Annex  II to 
Regulation (EC) No  1107/200 9. 
(13) It is therefore appropriate to renew the approval of etoxazole  as a candidate for 
substitution  pursuant to Article 24 of Regulation (EC) No  1107/2009 .  
(14) The risk assessment for the renewal of the approval of the active substance 
etoxazole  is based on representative uses as an acaricide. While it is not necess ary, in 
the light of this risk assessment,  to maintain the restriction to use only as an acaricide, 
it is, however, necessary to provide , in accordance with Article 14(1) of Regulation 
(EC) No 1107/2009 in conjunction with Article 6 thereof and in the ligh t of current 
scientific and technical knowledge, for certain conditions and restrictions. It is, in 
                                                 
6 EFSA Journal 2017;15(10):4988.  Available online: www.efsa.europa.eu . 
7 Commission Regulation (EU) 2018/605 of 19 April 2018 amending  Annex II to Regulation (EC) 
No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties   
(OJ L 101, 20.4.2018, p.  33). EN 4  EN particular, appropriate to restrict the use of plant protection products containing 
etoxazole  to use on ornamental plants  in permanent greenhouses . The restriction to 
ornamentals aims to exclude any dietary exposure of consumers because the risk 
assessment for processed commodities could not be finalised  and uncertainties are too 
high. As high risk was identified to aquatic  organisms, non -target arthrop ods and soil 
mites, t he restriction to greenhouses as defined in Article 3 of Regulation (EC) No 
1107/2009  aims to avoid exposure to the environment  and non -target organisms .  
(15) In order to increase the confidence in th e conclusion  that etoxazole  does not ha ve 
endocrine disrupting properties , the applicant should provide an updated assessment , 
in accordance with point 2.2 (b) of Annex  II to Regulation (EC) No 1107/2009, of the 
criteria laid down in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 
1107/2009, and in accordance with the guidance for the identification of endocrine 
disruptors8. 
(16) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly . 
(17) Implementing Regulation (EU) 2020/869  extended the approval period  of etoxazol e to 
31 July 2021  in order to allow the renewal process to be completed before the expiry 
of the approval period of that active substance. However, g iven that a decision on 
renewal has been  taken ahead of that extended expiry date , this Regulation shall ap ply 
from  1 February  2021.  
(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  
Renewal of the approval of the active substance  
The approval of the active substance  etoxazole  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 twentieth day following that of its publication in 
the Official Journal of the European Union . 
It shall apply from  1 February 2021 . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
                                                 
8 Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 
and (EC) No 1107/2009 ; https://efsa.onlinelibrarv.wilev.eom/doi/epdt710.2903/i.efsa.2018.5311 . EN 5  EN Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN