EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12796/2019  
[…](2019) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the approval of the active substance beta -cyfluthrin, 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 
amendin g the Annex to Commission Implementing Regulation (EU) No 540/2011  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the approval of the active substance beta -cyfluthrin, 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 plant protection products on  the market 
and repealing Council Directives  79/11 7/EEC and 91/414/EEC1, and in particular 
Article  20(1)   and Article 78(2) thereof,  
Whereas:  
(1) Commission Directive  2003/31/EC2 included beta-cyfluthrin  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 beta-cyfluthrin  as set out in Part A of the Annex 
to Implementing Regulation (EU) No 540/2011 , expires on  31 October  2020 .  
(4) An application for the renewal of the approval of the active substance beta-cyfluthrin  
was submitted in accorda nce with Article 1 of Commission Implementing Regulation 
(EU) No 844/20125 within the time period provided for in that Article.  
(5) The applicant s 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 2003/31/EC of 11 April 2003 amending Council Directive 91/414/EEC to 
include 2,4 -DB, beta -cyfluthrin, cyfluthrin, iprodione, linuron, maleic hydrazide and pendimethalin as 
active substances (OJ L 101, 23.4.2003, p. 3 ). 
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 Regulatio n 
(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 Foo d Safety 
Authority ( ‘the Aut hority’) and the Commission on 8 March  2017.  
(7) The Authority communicated the renewal assessment report to the applicant s and to 
the Member States for comments and forwarded the comments received to the 
Commission. The Authority also made the supplem entary summary dossier  available 
to the public . 
(8) On 9 August 2018 , the Authority communicated  to the Commission its conclusion6 on 
whether beta-cyfluthrin  can be expected to meet the approval criteria provided for in 
Article 4 of Regulation (EC) No 1107/200 9.  
(9) The Authority ident ified concerns. In particular, the Authority identified an unacceptable 
risk to workers loading and sowing the beet seeds treated with  beta-cyfluthrin . In 
addition, for cases of potato and wheat field applications  of beta-cyfluthrin  the Authority 
identified  high risk to residents, to non-target arthropods and to aquatic organisms. 
Furthermore , for the cases of use on  tomato es in greenhouses  (permanent and non -
permanent) , the Authority identified unacceptable risk to operators  and workers and , in 
case of  use on tomatoes in non-permanent greenhouses , to non -target arthropods . In 
addition, the consumer assessment could not be finalised based on the available data.  
(10) The Commission invited the applicant s to submit their comments on the conclusion of 
the Authority. Furthermore, in accordance with the third subparagraph of  Article  14(1) 
of Implementing Regulation (EU) No 844/2012, the Commission invited the 
applicant s to submit comments on the renewal report. The applicant s submitted their 
comment s, which have been carefully examined.  
(11) However, despite the arguments put forward by the applicant s, the concerns regarding 
the active substance  could not be eliminated.  
(12) Consequently, it has not been  established with respect to one or more representative 
uses of at least one plant protection product 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 beta-cyfluthrin  in accordance with 
Article  20(1)(b) of that Regulation . 
(13) Implementing Regulation (EU) No 540/2011 should  therefore be amended 
accordingly.  
(14) Member States should be provided with  sufficient  time to withdraw authorisatio ns for 
plant protection products containing beta-cyfluthrin . 
(15) For plant protection products containing beta-cyfluthrin , where Member States grant 
any grace period in accordance with Article  46 of Regulation (EC) No 1107/2009, t hat 
period should  not exceed 12 months  from the date of entry into force of this 
Regulation  
(16) Commission Implementing Regulation (EU) 2019/15897 extended the approval period  
of beta-cyfluthrin  to 31 October  2020  in order to allow the renewal process to be 
                                                 
6 EFSA (European Food Safety Auth ority), 2018 . Conclusion on the peer review of the pesticide risk 
assessment of the active substance  beta-cyflut hrin, EFSA Journal 2018;16(9):5405 . 
 
 EN 3  EN completed before the expiry of that approval period . However, g iven that a decision on 
the non -renewal of the approval is  taken ahead of the expiry of that extended approval 
period , this Regulation should apply as soon as possible.  
(17) This Regulation does not prevent  the submission of a fu rther application for the 
approval of beta-cyfluthrin  pursuant to  Article 7 of Regulation (EC) No 1107/2009.  
(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 AD OPTED THIS REGULATION:  
Article 1  
Non-renewal of the approval of the active substance  
The approval of the active substance beta-cyfluthrin  is not renewed.   
Article 2 
Amendment  to Implementing Regulation (EU) No 540/2011  
In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row  48, on 
beta-cyfluthrin , is deleted.  
Article 3 
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing beta-
cyfluthrin  as an active substance by [ Office of Publications please insert date corresponding 
to 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 expir e by [Office of Publications please insert date corresponding to 
12 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 .  
                                                                                                                                                         
7 Commission Implementing Regulation (EU) 2019/1589 of 26 September  2019 amending Implementing 
Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 
amidosulfuron, beta -cyfluthrin, bifenox, chlorotoluron, clofentezine, clomazone, cypermethrin, 
daminozide, deltamethrin, dicam ba, difenoconazole, diflubenzuron, diflufenican, fenoxaprop -P, 
fenpropidin, fludioxonil, flufenacet, fosthiazate, indoxacarb, lenacil, MCPA, MCPB, nicosulfuron, 
picloram, prosulfocarb, pyriproxyfen, thiophanate -methyl, triflusulfuron and tritosulfuron ( OJ L 248, 
27.9.2019, p.  24). EN 4  EN  
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