EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10590/2021 Rev. 0  
[…](2021) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
renewing the approval of the active substance cypermethrin 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 cypermethrin 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 re levance)  
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 protecti on 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  2005/53/EC2 included cypermethrin  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 cypermethrin , as set out in Part A of the Annex to 
Implementing Regulation (EU) No 540/2011 , expires on 31 October  2022. 
(4) An application for the renewal of the approval of cypermethrin  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 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 2005/53/EC of 16 September 2005 amending Council Directive 91/414/EEC to 
include chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate -methyl as active 
substances (OJ L 241, 17.9.2005, p. 51 ). 
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 Europe an 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 re newal 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 submitted it to the European 
Food Safety Authority (‘the Authority’) and the Commission on  8 May 2017 . 
(7) The Authority made the supplementary summary dossier available to the public. The 
Authority also circulated the draft renewal assessment report to the applicant s 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 8 August 2018 , the Authority communicated to the Commission its conclusion6 on 
whether  cypermethrin  can be expec ted to meet the approval criteria provided for in 
Article  4 of Regulation (EC) No 1107/2009. Following discussions with the Member 
States,  the Authority was mandated by the Commission to examine additional risk 
mitigation measures that were not included in  the Authority’s conclusion . In its 
statement on risk mitigation measures on cypermethrin published on 4  October  20197, 
the Authority presented the levels of the necessary drift reduction and the measures 
that would be needed  to demonstrate low risk to th e non-target organisms , in particular 
aquatic organisms and non -target arthropods, including bees . The Commission 
presented a draft renewal report for cypermethrin  to the Standing Committee on Plants, 
Animals, Food and Feed on 24 -25 January  2019.  
(9) As regards  the criteria to identify endocrine disrupting properties introduced by 
Commission Regulation (EU) 2018/6058, on the basis of the available scientific 
information summarised in  the conclusion of the Authority, the Commission 
considers that cypermethrin is not to be considered as having endocrine disrupting 
properties.  
(10) The Commission invited the applicant s to submit comments on the conclusion 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 s 
submitted comments, which have been carefully examined.  
(11) The representative uses are spray applications outdoors, for which the approval criteria 
provided for in Article 4 of Regulation (EC) No 1107/2009 are satis fied provided that  
appropriate mitigation measures are taken to ensure the required protection l evel for 
aquatic organisms  and non-targeted arthropods including bees. Therefore, i t has been 
established with respect to one or more representative uses of at least one plant 
protection product containing  cypermethrin  that the approval criteria provided for in 
Article 4 of Regulation (EC) No 1107/2009 are satisfied  where  appropriate  conditions 
and restrictions according to Article 6 of Regulation (EC) No  1107/20 09 are set.  
(12) The risk assessment for the renewal of the approval of  cypermethrin  is based on a 
limited number of representative uses, which however do not restrict the uses for 
which plant protection products containing  cypermethrin  may be authorised. It i s 
therefore appropriate not to maintain the restriction to use as a n insecticide.  
(13) The Commission , however,  considers that cypermethrin  is a candidate for substitution 
pursuant to Article 24 of Regulation (EC) No 1107/2009.  Given that  cypermethrin  is a 
                                                 
6 EFSA Journal  2018;16(8):5 402. Conclusion on the peer review of the pesticide risk ass essment of the 
active substance cypermethrin. Available online: www.efsa.europa.eu . 
7 https://www.efsa.europa.eu/en/efsajournal/pub/5822 . 
8 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 1 01, 20.4.2018, p.  33). EN 4  EN mixture of eight isomers, and it contains a significant proportion of non -active 
isomer s, it fulfils the condition set out in the fourth indent of point  4 of Annex  II to 
Regulation (EC) No  1107/2009.  
(14) It is therefore appropriate to renew the approval of cypermethrin as a candidate for 
substitution.  
(15) 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 provide for cert ain conditions  and restrictions . It is, in 
particular, appropriate to require further confirmatory information.   
(16) In order to increase the confidence in th e conclusion  that cypermethrin  does not have 
endocrine disrupting properties , the applicant s 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, as amended by Regulation (EU)  2018/605 and in accordance with the 
guidance for the identification of endocrine disruptors9. 
(17) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly.  
(18) Commission Implementing Regulation (EU) XX/20XX <Regulation with latest 
extension>10 extended t he approval period  of cypermethrin  to 31 October 2022 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 e xpiry date, this Regulation shall apply as soon as 
possible.  
(19) The measures provided for in this Regulation are in accordance 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  
The approval of the active substance  cypermethrin  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 Regulatio n shall enter into force on twentieth  day following that of its publication in the 
Official Journal of the European Union . 
                                                 
9 Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 
and (EC) No 1107/2009. https://efsa.onlin elibrarv.wilev.eom/doi/epdt710.2903/i.efsa.2018.5311 . 
10  OJ XX, XX.XX.XXXX, p. XX  EN 5  EN It shall apply  from  1 February 2022.  
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  