EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10196/2018 
(POOL/E4/2018/10196/10196 -EN.doc)  
[…](2018) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving cypermethrin as an existing active substance for use in biocidal products of 
product -type 18  
(Text with EEA relevance)    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving cypermethrin as an existing active substance for use in biocidal products of 
product -type 18  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to Regulation (EU) No  528/2012 of the European Parliament and of the 
Council of 22  May 2012 concerning the making available on the market and use of biocidal 
products1, and in particular the third subparagraph of Article  89(1) thereof,  
Wherea s: 
(1) Commission Delegated Regulation (EU) No  1062/20142 establishes a list of existing 
active substances to be evaluated for their possible approval for use in biocidal 
products.  That list includes cypermethrin . 
(2) Cypermethrin  has been evaluated for use in products of product -type 18,  insecticides, 
acaricides and products to control other arthropods , as d escribed  in Annex  V to  
Regulation (EU) No  528/2012 . 
(3) Belgium  was designated as  a rapporteur Member State  and its evaluating competent 
authority submitted the assessment report to gether with its recommendations  on 
15 April 2015 . 
(4) In accordance with Article 7(2) of Delegated  Regulation  (EU) No  1062/2014, the 
opinion  of the European Chemicals Agency w as formulated on  5 May 2017 by the 
Biocidal Product s Committee, h aving regard to the conclusions of the evaluating 
competent authority3. 
(5) According to th at opinion, biocidal products of product -type 18 containing 
cypermethrin  may be expected to satisfy the criteria  of Article  19(1)(b) of Regulation 
(EU) No 528/2012 , provided that certain specifications and conditions concerning 
their use are complied with.  
(6) It is therefore appropriate to approve cypermethrin  for use in  biocidal products of 
product -type 18, subject to compliance with certain specifications and conditions . 
(7) Furthermore, a  need to further investigate the endocrine disrupting potential of 
cypermethrin has been identified in a screening study carried out in preparation of the 
                                                 
1 OJ L  167, 27.6.2012, p.  1. 
2 Commission Delegated Regula tion (EU) No 1062 /2014 of 4 August 2014  on the work programme for 
the systematic examination of all existing active substances contained in biocidal products referred to in 
Regulation (EU) No 528/2012 of the European Parliament and of the Council  (OJ L 294, 10.10.2014, 
p. 1). 
3 Biocidal Products Committee (BPC) Opinion o n the application for approval of the active substance 
Cypermethrin, Product type: PT 18, ECHA/BPC/153/2017, Adopted on 5 May 2017   
EN 2  EN impact assessment conducted by the Commission on various options to set criteria to 
identify endocrine disruptors4. An asse ssment of the potential endocrine disrupting 
properties of cypermethrin will also be conducted in the context of Regulation (EC) 
No 1107/2009  of the European Parliament and of the Council5, and the  conclusions  
thereof ar e expected before the end of 2018. Depending on the outcome of that 
assessment, the Commission will consider the need to review the approval of 
cypermethrin as active substance for use  in biocidal products in accordance with 
Article 15 of Regulation (EU) N o 528/2012.  
(8) A reasonable period should be allowed to elapse before an active substance is 
approved in order to permit interested parties to take the preparatory measures 
necessary to meet the new requirements.  
(9) The measures provided for in this Regulation a re in accordance with the opinion of the 
Standing  Committee on Biocidal Product s, 
HAS ADOPTED THIS REGULATION:  
Article  1 
Cypermethrin is  approved as an active substance for use in biocidal products of product -type 
18, subject to the specifications and cond itions set out in the Annex.  
Article  2 
This Regulation 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.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER  
                                                 
4 COM (2016) 350 final.  
5 Regulation (EC) No  1107/2009 of the European Parliament and of the Council of 21  October 2009 
conce rning the placing of plant protection products on the market and repealing Council Directives 
79/117/EEC and 91/414/EEC  (OJ L 309, 24.11.2009, p. 1 ).