EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/699 
(POOL/E4/2023/699/699 -EN.docx)  
[…](2023) 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 -type 4 in accordance with Regulation (EU) No 528/2012 of the 
European Parliament and of the Council  
(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 -type 4 in accordance with Regulation (EU) No 528/2012 of the 
European Parliament and of the Council  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard t o 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  Article 89(1), third subparagraph,  thereof,  
Whereas:  
(1) Commission Delegated Regulation (EU) No 1062/20142 establishes a list of e xisting 
active substa nces to be evaluated for their possible approval for use in biocidal 
products. That list includes silver copper zeolite (CAS No : 130328 -19-7) for product -
type 4 . 
(2) Sweden was designated as the rapporteur Member State . Silver copper zeolite has been 
evaluated by the competent authority of Sweden (‘the evaluating competent authority’)  
for use in  biocidal products of product -type 4, food and feed area  disinfectants , as 
referred t o in Annex V to Regulation (EU) No  528/2012.  
(3) On 12 June 2017, the evaluating competent authority submitted the assessment report 
on the application together with the conclusions of its evaluation to the  European 
Chemical s Agency (‘ ECHA’ ). ECHA discussed the assessment report and the 
conclusions in technical meetings.  
(4) In accordance with Article 75(1), second subparagraph, point (a), of Regulation (EU) 
No 528/2012, the Biocidal Products Committee prepares the opinion of ECHA  
regarding the applications for a pproval of active substances. In accordance with 
Article 7 (2) of Delegated  Regulation (EU) No  1062/2014  read in conjunction with 
Article 75(1) and (4) of Regulation (EU) No 528/2012 , the Biocidal Products 
Committee adopted the opinion of ECHA  on 3 March 20 213, having regard to the 
conclusions of the evaluating competent authority . 
                                                 
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 Council (OJ L 294, 10.10.2014, 
p. 1). 
3 Biocidal Products Committee  Opinion on the application for approval of the active substance : silver 
copper zeolite , Product type: 4, ECHA/BPC/ 277/2021, a dopted on 3 March 2021.   
EN 2  EN (5) In its opinion , ECHA  concludes that sufficient efficacy has not been demonstrated for 
the use consisting in the incorporation of the representative biocidal product into food 
contact materials. Therefore, biocidal products of product -type 4 containing  silver 
copper zeolite are not expected to meet the criteri on set out  in Article 19(1) , point 
(b)(i) of Regulation (EU) No 528/2012 . 
(6) ECHA also concludes that unacceptable risks for human health have been identified 
from the consumption of food which has been in contact with treated polymers, and no 
adequate risk mitigation measure could be identified to mitigate those risks. Therefore, 
biocidal p roducts of product -type 4 containing silver copper zeolite are not expected to 
meet the criterion set out in Article 19(1), point (b)(i ii) of Regulation (EU) No 
528/2012 . 
(7) Taking into account the opinion of ECHA , it is appropriate not to approve silver 
copp er zeolite as an active substance for use in biocidal products of product -type 4. 
(8) 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 (CAS No: 130328 -19-7) is not approved as an active substance for use in 
biocidal products of product -type 4. 
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