EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10564/2019 
(POOL/E4/2019/10564/10564 -EN.doc)  
[…](2019) XXX  draft  
 
COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
not approving silver copper zeolite as an existing active substance for use in biocidal 
products of product -types 2 and 7  
(Text with EEA relevance)    
EN 1  EN COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
not approving silver copper zeolite as an existing active substance for use in biocidal 
products of product -types 2 and 7  
(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 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 existing 
active substances to be evaluated for their possible approv al for use in biocidal 
products. That list includes silver copper zeolite  (EC No: n.a., CAS No: 130328 -19-7). 
(2) Silver  copper zeolite  has been evaluated for use in  products of product -type 2, 
disinfectants and algaecides not intended for direct application to humans or animals , 
and of product -type 7, film preservatives , as described in Annex V to Regulation (EU) 
No 528/2012.  
(3) Swed en was designated as  a rapporteur Member State and its  competent authority 
submitted the assessment reports together with its conclusions  to the European 
Chemicals Agency  on 12 June 2017 . 
(4) In accordance with Article 7 (2) of Delegated  Regulation (EU) No 1062/2014 , the 
opinion s of the European Chemicals Agency3 were adopted  on 17 October 2018  by the  
Biocidal Product s Committee , having regard to the conclusions of the evaluating 
competent authority.  
(5) According to th ose opinion s, biocidal products of product-types 2 and 7 containing 
silver copper zeolite  may not be expected to meet the criteria  laid down in 
Article  19(1)(b) of Regulation (EU) No 528/2012  as sufficient efficacy has not been 
demonstrated . 
(6) Taking into account the opinions of the European Chemicals Agency, it is not 
appropriate to approve silver copper zeolite  for use in biocidal products of product -
                                                 
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 on the application for approval of the active substance 
Silver copper zeolite, Product type: 2, ECHA/BPC/210/2018, adopted on 17 October 2018; Bi ocidal 
Products Committee (BPC)  opinion on the application for approval of the active substance Silver 
copper zeolite, Product type: 7, ECHA/BPC/213/2018, adopted on 17 October 2018 .  
EN 2  EN types 2 and 7 , as the conditions laid down in Article 4(1) of Regulation (EU) No 
528/2012 are not satisfied . 
(7) 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  
Silver copper zeolite  (EC No: n.a., CAS No: 130328 -19-7) is not  approved as a n active 
substance for use in bio cidal products of product -types 2 and 7 . 
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