EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10632/2020 
(POOL/E4/2020/10632/10632 -EN.docx)  
[…](2020) XXX  draft  
 
COMMISSION IMPLEMENTING DECISION  
of XXX  
not approving chlorophene as an existing active substance for use in biocidal products of 
product -type 2  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING DECISION  
of XXX  
not approving chlorophene as an existing active substance for use in biocidal products of 
product -type 2  
(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 chlorophene  (EC No: 204-385-8; CAS No 120-32-1). 
(2) Chlorophene  has been evaluated for use in  biocidal products of product -type 2, 
disinfectants and algaecides not intended for direct application to humans or animals , 
as described  in Annex V to Regulation (EU) No  528/2012.  
(3) Norway  was designated as a rapporteur State  and its evaluating competent authority 
submitted the assessment report together with its conclusions to the European 
Chemicals Agency  (‘Agency’)  on 22 December 2016.  
(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 4 March 20203, 
having regard to the conclusions of the evaluating competent aut hority.  
(5) According to that opinion,  biocidal products of product -type 2 containing chlorophene  
may not be expected to meet  the criteria  laid down in Article 19(1)(b)  of Regulation 
(EU) No 528/2012  as the human health  risk assessment identified unacceptable  risks. 
(6) Taking into account the opinion of the Agency , it is not appropriate to approve 
chlorophene  for use in biocidal products of product -type 2.  
(7) The measures provided 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 : 
Chlorophene, Product type: 2, ECHA/BPC/2 38/2020, a dopted on 4 March 2020.  EN 2  EN HAS ADOPTED THIS DECISION:  
Article 1  
Chlorophene  (EC No: 204-385-8, CAS No: 120-32-1) is not approved as an active substance 
for use in biocidal products of product -type 2. 
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