EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/12069/2017 CIS 
(POOL/E4/2017/12069/12069 -EN 
CIS.doc)  
[…](2018) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving cyphenothrin 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 cyphenothrin 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 approv al for use in biocidal 
products. That list includes cyphenothrin . 
(2) Cyphenothrin  has been evaluated for use in  biocidal products of product -type 18, 
insecticides, acaricides and products to control other arthropods, as de scribed  in 
Annex  V to Directive  98/8/EC of the European Parliament and of the Council3, which 
corresponds to product -type 18 as de scribed  in Anne x V to  Regulation (EU) 
No 528/2012 . 
(3) Greece  was designated as a rapporteur Member State  and its evaluating competent 
authority submitted the assessment report together with its recommendations  on 
11 April 2013 . 
(4) In accordance with Article 7(2) of Delegated R egulation (EU) No  1062/2014, the 
opinion of the European Chemicals Agency was formulated on 14 December 2017  by 
the Biocidal Product s Committee , having regard to the conclusions of the evaluating 
competent authority4.  
(5) It can be derived from Article  90(2) of Regulation (EU) No 528/2012  that substances 
for which the Member States' evaluation has been completed  by 1  September 2013 
should be evaluated while taking into account the conditions set out in Article 5 of 
Directive  98/8/EC. Following the  opinion  of the European Chemicals Agency , 
biocidal products of product -type 18 containing cyphenothrin  may be expected to 
                                                 
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 Directive 98/8/EC  of the European Parliament and of the Council of 16 February 1998 concerning the 
placing of biocidal products on the market  (OJ L 123, 24.4.1998, p. 1 ). 
4 Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance 
Cyphenothrin, Product type: 18, ECHA/BPC/183/2017, Adopted on 14 December 2017 .  
EN 2  EN satisfy the requirements of Article  5 of Directive  98/8/EC , provided that certain 
specifications and conditions concerning their use are complied  with.  
(6) It is therefore  appropriate to approve cyphenothrin  for use in  biocidal products of 
product -type 18, subject to compliance with certain specifications and conditions . 
(7) The opinion of the European Chemicals Agency concludes that cyphenothrin  meets 
the criteria for being a  persistent ( P) and toxic (T)  substance  in accordance with Annex 
XIII to Regulation (EC) No 1907/2006 of the Europea n Parliament and of the 
Council5. 
(8) For the purpose s of Regulation (EU) No  528/2012 , cyphenothrin meets  the conditions 
set out in point (d) of Article  10(1) of Regulation (EU) No  528/2012  and should be 
therefore considered a candidate for substitution. The receiving competent authority 
or, in the case of an evaluation of an application for a Union authorisation, the 
evaluating competent authority, sh ould perform a comparative assessment as part of 
the evaluation of an application for authorisation or for renewal of authorisation of a 
biocidal product containing cyphenothrin . 
(9) Since  it can be derived from Article  90(2) of Regulation (EU) No 528/2012  that 
substances for which the Member States' evaluation has been completed  by 
1 September 2013 should be approved under the terms of Directive  98/8/EC , the 
period of approval should be 10  years , in accordance with the practic e established 
under that Directive . 
(10) 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.  
(11) The measures provided  for in this Regulation are in accordance with the opinion of the 
Standing  Committee on Biocidal Product s, 
HAS ADOPTED THIS REGULATION:  
Article  1 
Cyphenothrin  is approved as an active substance for use in biocidal products of product -type 
18, subject to th e specifications and conditions 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 an d directly applicable in all Member States.  
                                                 
5 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning the Registration, Evaluation, Authorisation and Restriction of Chemica ls (REACH), 
establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council 
Regulation (EEC) No  793/93 and Commission Regulation (EC) No 1488/94 as well as Council 
Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 
2000/21/EC (OJ L 396, 30.12.2006, p. 1) .  
EN 3  EN Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER