EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11462/2020 
(POOL/E4/2020/11462/11462 -EN.docx)  
[…](2020) XXX  draft  
 
COMMISSION IMPLEMENTING DECISION  
of XXX  
not approving esbiothrin as an existing active substance for use in biocidal products of 
product -type 18  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING DECISION  
of XXX  
not approving esbiothrin 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,  
Whereas:  
(1) Commission Delegated Regulation (EU) No 1062/20142 establishes a list of e xisting 
active substances to be evaluated for their possible ap proval for use in biocidal 
products. That lists includes esbiothrin  (EC No: Not available ; CAS No : 260359 -57-
7). 
(2) Esbiothrin  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 Regulation (EU) No  528/2012.  
(3) Germany  was designated as the rapporteur Member State  and its evaluating competent 
authority submitted the assessment report together with its conclusions to the 
European Chemicals Agency  (‘the Agency’)  on 11 January 2017 . 
(4) In accordance with Article 7 (2) of Delegated  Regulation (EU) No  1062/2014 , the 
Biocidal Products Committee adopted the opinion of the Agency on 16 June  20203, 
having regard to the conclusions of the evaluating competent authority.  
(5) According to that opinion,  biocidal products of product -type 18 containing esbiothrin  
may not be expected to meet  the criteria  laid down in Article 19(1)(b)  of Regulation 
(EU) No 52 8/2012  as the human health  risk assessment identified unacceptable risk s. 
(6) Taking into account the opinion of the Agency , the Commission considers it not 
appropriate to approve esbiothrin  for use in biocidal products of product -type 18.  
(7) The measures provid ed for in this Decision are in accordance with the opinion of the 
Standing Committee  on Biocidal products,  
                                                 
1 OJ L 167, 27.6.2012,  p. 1.  
2 Commission Delegated Regulation (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 a nd of the Co uncil (OJ L 294, 10.10.2014, 
p. 1). 
3 Biocidal Products Committee  Opinion on the application for approval of the active substance : 
Esbiothrin , Product type: 18, ECHA/BPC/2 60/2020, a dopted on 16 June 2020.  EN 2  EN HAS ADOPTED THIS DECISION:  
Article 1  
Esbiothrin  (EC No: Not available; CAS No : 260359 -57-7) is not approved as an active 
substance for use in biocidal 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  
 Ursula VON DER  LEYEN