EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12548/2020 Rev. 1  
[…](2020) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
withdrawing the approval of the active substance alpha -cypermethrin  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 Im plementing Regulation (EU) No 540/2011  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
withdrawing the approval of the active substance alpha -cypermethrin  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 the second 
alternative of Article 21(3)  and Article 78(2) thereof,  
Whereas:  
(1) Commission Directive 2004/58/EC2 included  alpha -cypermethrin  as an active 
substance in Annex  I to Council Directive  91/414/EEC3. Active substances included in 
Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation 
(EC) No  1107/2009 . 
(2) Commis sion Implementing Regulation  2019/16904 renewed the ap proval of the active 
substance alpha -cyper methrin as a candidate for substitution.  Consequently, that active 
substance was listed in part E of the Annex to Commission Implementing Regulation 
(EU) No 540/20115.  
(3) Implementing Regulation 2019/1690  required  that the applicant  submit ted to the 
Commission, the Member States and the Authority confirmatory information  as 
regards the toxicological profile of certain metabolites by 30  October  2020. In 
addition, confirmatory information had been required for three other points by other 
deadlin es set out in the Annex I of the  Commission Implementing Regulation 
(EU)  2019/1690 .  
                                                 
1 OJ L 309, 24.11.2009 , p. 1. 
2 Commission Directive 2004/58/EC of 23 April 2004 amending Council Directive 91/414/EEC to 
include alpha -cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil and phenmedipham as 
active substances  (OJ L 120,  24.4.2004, p.  26). 
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) 2019/1690 of 9 October 2019 renewing the approval of the 
active substance alpha -cypermethrin, as a candidate for substitution, in accordance with Regulation 
(EC) No 1107/2009 of the European Parliament and of the Council concerning the pla cing of plant 
protection products on the market, and amending the Annex to Commission Implementing Regulation 
(EU) No 540/2011  (OJ L 259, 10.10.2019, p.  2) 
5 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). EN 2  EN (4) In October 2020, the applicant informed the Commission, the rapporteur Member 
State and the Authority that it would not submit any confirmatory data  for any of the 
four points where confirmatory information were requested. . 
(5) Consequently, it is appropriate to withdraw the approval of that active substance .  
(6) The Annex to  Implementing Regulation (EU) No 540/2011 should therefore be 
amended accordingly.  
(7) Member States should be provided with time to withdraw authorisations for plant 
protection products containing  alpha -cypermethrin . 
(8) For plant protection products containing  alpha -cypermethrin , where Member States 
grant any grace period in accordance with Art icle 46 of Regulation (EC) 
No 1107/2009, th at period should , at the latest,  expire  on [Office of Publications 
please  insert date 12 months from the date of entry into force ]. 
(9) 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  
Withdrawal of approval  
The a pproval of the active substance  alpha -cypermethr in is withdrawn.  
Article 2 
Amendment to Implementing Regulation (EU) No 540/2011  
In Part E  of the Annex to Implementing Regulation (EU) No 540/2011, row 12 on 
alpha -cypermethrin  is deleted.  
Article 3 
Transitional measures  
Member States shall withdraw auth orisations for plant protection products containing alpha -
cypermethrin  as active substance  by [Office of Publications please insert date 6 m onths after 
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 12 months  from the date of entry into force]  at the latest.   
Article 5 
Entry into force  
This Regulat ion 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.  EN 3  EN Done at Brussels,  
 For the Commi ssion  
 The President  
Ursula VON DER LEYEN