EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10566/2019 
(POOL/E4/2019/10566/10566 -EN.doc)  
[…](2019) XXX  draft  
 
COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
not approving silver 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 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 concern ing 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 zeolite  (EC No: n.a., CAS No: 130328 -18-6). 
(2) Silver zeolite  has been evaluated for use in  products of produ ct-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) Sweden  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 zeolite  may not be expec ted 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 opinion s of the European Chemicals Agency, it is not 
appropriate to approve silver zeolite  for use in biocidal products of product -types 2 
                                                 
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 C ouncil  (OJ L 294, 10.10.2014 , 
p. 1). 
3 Biocidal Products Committee (BPC) opinion on the application for approval of the active substance 
Silver zeolite, Product type: 2, ECHA/BPC/209/2018, adopted on 17 October 2018; Biocidal Products 
Committee (BPC) opini on on the application for approval of the active substance Silver zeolite, Product 
type: 7, ECHA/BPC/212/2018, adopted on 17 October 2018 .  
EN 2  EN 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 zeolite  (EC No: n.a., CAS No: 130328 -18-6) is not  approved as an 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