EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/12070/2017 CIS 
(POOL/E3/2017/12070/12070 -EN 
CIS.doc)  
[…](2018) XXX  draft  
 
COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
not approving empenthrin as an existing active substance for use in biocidal products of 
product -type 18  
(Text with EEA relevance)    
EN 1  EN COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
not approving empenthrin 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 
Counc il of 22 May 2012 concerning th e making available on the market and use of biocidal 
products1, and in particular Article 89(1) thereof , 
Whereas:  
(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 empenthrin (EC No: n.a., CAS No: 54406 -48-3). 
(2) Empenthrin  has been evaluated for use in  products of product -type 18, insecticides, 
acaricides and products to control other arthropods , as described in Annex  V to 
Regulation (EU) No  528/2012.  
(3) Belgium  was designated as evaluating competent authority and submitted the 
assessment reports together with its recommendations on 24 June 2016 . 
(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 13 December  2017  by 
the Biocidal Product s Committee , having regard to the conclusions of the evaluating 
competent authority3.  
(5) According to th at opinion,  biocidal products used for product -type 18 c ontaining 
empe nthrin  may not be expected to satisfy the requirements laid down in 
Article  19(1)(b) of Regulation (EU) No 528/2012.  
(6) In particular, according to Article 6(2) of Regulation (EU) No 528/2012, sufficient 
data is to  be provided by the appli cant in order to make it possible to determine 
whether an active substance meets the exclusion criteria referred to in Article 5(1)  of 
that Regulation . The applicant has been requested on several occasions by the 
evaluating competent authority to provide d ata on carcinogenicity to perform this 
assessment, and failed to provide sufficient data in due time , making it impossible to 
assess the exclusion criteri on set out in Article 5(1)(a) of that Regulation . 
                                                 
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 52 8/2012 of the European Parliament and of the Council  (OJ L 294, 10.10.2014 , 
p. 1). 
3 Biocidal Products Committee (BPC), Opinion on the application for approval of the active substance 
Empenthrin, Product type: 18, ECHA/BPC/182/2017, Adopted on 13 December 2017 .  
EN 2  EN (7) In addition , the scenarios evaluated in the human he alth and environmental risk 
assessments identified unacceptable risks and no safe use could be identified.  
(8) It is therefore not appropriate to approve empenthrin  for use in biocidal products of 
product -type 18.  
(9) The measures provided for in this Decision are in accordance with the opinion of the  
Standing Committee on Biocidal  Products , 
HAS ADOPTED THIS DECISION:  
Article 1  
Empenthrin  (EC No: n.a., CAS No: 54406 -48-3) is not  approved as an active substance for 
use in bio cidal products of product -type 18. 
Article 2 
This Decision shall enter into force on the twentieth  day following that of its publication in 
the Official Journal of the European Union . 
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER