EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10236/2017 rev 1  
[…](2017) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -approval of the active substance beta -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  
(Text with EEA relevance)    
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning  the non -approval of the active substance beta -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  
(Text with EEA relevance)  
THE EUROPE AN 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 m arket 
and repealing Council Directives 79/117/EEC and 91/414/EEC1, and in particular 
Article  13(2) thereof,  
Whereas:  
(1) In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council 
Directive 91/414/EEC2 is to apply, with respect to the procedure and the conditions for 
approval, to active substances for which a decision has been adopted in accordance 
with Article  6(3) of that Directive before 14  June 2011. For beta-cypermethrin  the 
conditions of Article  80(1)(a) of Regulation (EC) No  1107/2009 are fulfilled by 
Commission Implementing Decision  2011/266/EU3. 
(2) In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom 
received an application from Cerexagri S.A.S. on 13  November  2009  for the in clusion 
of the active substance beta-cypermethrin  in Annex  I to Di rective  91/414/EEC. 
Implementing Decision 2011 /266/E U confirmed that the dossier was ‘complete’ in the 
sense that it could be considered as satisfying, in principle, the data and information  
requirements of Annexes  II and III to Directive  91/414/EEC.  
(3) For that active substance, the assessment of the effects on human and animal health 
and the environment for the uses proposed by the applicant has been carried out in 
accordance with the procedur e provided in Article 6(2) and (4) of 
Directive  91/414/EEC. The designated rapporteur Member State submitted a draft 
assessment report on 4  April  2013.  
(4) The draft assessment report was reviewed by the Member States and the European 
Food Safety Authority (‘ the Authority’). The Authority presented to the Commission 
its conclusion on the pesticide risk assessment of the active substance beta-
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 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).  
3 Commission Implementing Decision 2011/266/EU  of 2  May 2011 recognising in principle the 
completeness of the dossier submitted for detailed examination in view of the possible inclusion of 
beta-cypermethrin, eugenol, geraniol and thymol in Annex I to Council Directive 91/414/EEC  
(OJ L 114, 4.5.2011, p.  3).  
EN 3   EN cypermethrin4 on 27 May  2014. The Authority concluded that for the uses of beta -
cypermethrin assessed there is a high risk to aquatic organisms, bees and non -target 
arthropods. In addition, the risk assessment for soil and aquatic organisms and the 
exposure assessment for groundwater could not be finalised as insufficient information 
was provided in relati on to the fate and behaviour of the cyclopropyl ring moiety of 
beta-cypermethrin. Furthermore, information on metabolism in livestock , which is 
necessary  to confirm the residue definition for animal products , and information on the 
toxicity profile of meta bolite PBA and its relevance for consumer risk assessment , 
were not provided . 
(5) Consequently, it was not possible to conclude on the basis of the information available 
that beta-cypermethrin  meets the criteria for inclusion in Annex  I to 
Directi ve 91/414/EEC . 
(6) The Commission invited the applicant to submit its comments on the conclusion of the 
Authority . Furthermore, in accordance with Article  9 of Regulation (EU) 
No 188/20115, the Commission invited the applicant to submit comments on the draft 
review report . The applicant submitted its comments, which have been carefully 
examined.  
(7) Despite the arguments put forward by the applicant, the concerns referred to in 
recital  4 could  not be eliminated. Consequently,  it has not been demonstrated that it 
may be expected  that, under the proposed conditions of use, plant p rotection product s 
containing beta -cypermethrin satisfy in general the re quirements laid down in 
Article  5(1)(a) and (b) of Directive  91/414/EEC.   
(8) Beta-cypermethrin should therefore not be approved in ac cordance with  Article 13(2) 
of Regulation (EC) No  1107/2009.  
(9) This Regulation does not prevent the applicant from submitting  a further application for 
beta-cypermethrin  in accordance with  Article  7 of Regulation (EC) No  1107/2009.  
(10) 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  
Non-approval of active substance  
The active substance beta-cypermethrin  is not approved.   
Article 2 
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 . 
                                                 
4 EFSA Journal (2014) 12(6):3717, Conclusion on the peer review of the pesticide risk assessment of the  
active substance beta -cypermethrin. EFSA Journal 2014;12(6):3717, 90 pp. 
doi:10.2903/j.efsa.2014.3717 . 
5 Commission Regulation (EU) No 188/2011 of 25 February 2011 laying down detailed rules for the 
implementation of Council Directive 91/414/EEC as regard s the procedure for the assessment of active 
substances which were not on the market 2 years after the date of notification of that Directive 
(OJ L 53, 26.2.2011, p. 51) .  
EN 4   EN This Regulation shall be binding in its entirety and directly applicable i n all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER