EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/700  
(POOL/E4/2023/700/700 -EN.docx)  
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
not approving silver zinc 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 zinc 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 zinc zeolite (CAS No : 130328 -20-0) for product -
type 4 . 
(2) Sweden was designated as the rapporteur Member State. Silver zinc 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 to  in Annex V to Directive 98/8/EC of the European Parliament and of the 
Council3, which correspond s to product -type 4, food and feed area  disinfectants , as 
referred to  in Annex V to Regulation (EU) No  528/2012.  In the application for 
approval, the applicant submitted a representative biocidal product supported for two 
example uses: the incorporation into polymers used in food contact materials to reduce 
cross contamination of pathogens and the incorporation into materials used in water 
filters to co ntrol the growth of bacteria.  
(3) On 7 May 2012, the evaluating competent authority submitted the assessment report 
on the application together with the conclusions of its evaluation to the Commission . It 
follows from Article 90(2) , first subparagraph,  of Regu lation (EU) No 528/2012 that 
substances for which the Member States’ evaluation has been completed by 1 
September 2013 are to  be evaluated in accordance with the provisions of Directive 
98/8/EC. The European Chemical s Agency (‘ ECHA’ ) discussed the assessme nt report 
and the conclusions in technical meetings.  
                                                 
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 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the 
placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).   
EN 2  EN (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 approval of a ctive 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 20214, having regard to the 
conclusions of the evaluating competent authority . 
(5) It results from the conclusions of the opinion of ECHA that, concerning the 
incorporation of silver zinc zeolite into polymers used in food contact materials, 
sufficient efficacy has not been  demonstrated. Furthermore, 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 mitig ate those risks.    
(6) As regards the incorporation of silver zinc zeolite into materials used in water filters,  
ECHA identified unacceptable risks for infants (6 to 12 months old)  consuming water 
filtered  through materials treated with silver zinc zeolite.  The applicant proposed a risk 
mitigation measure  in order to ensure that infants would not be exposed to silver zinc 
zeolite above the acceptable threshold, namely to restrict the use of treated water 
filters to commercial, hospitality and institutional est ablishments and prohibit 
residential use, including also a mandatory labelling of filters. However, the Biocidal 
Products Committee found this measure insufficient, as it cannot be excluded that 
infants are exposed to unacceptable levels of silver zinc zeo lite via the consumption of 
filtered drinking water in restaurants and bars,  especially when it comes to infants 
residing in the premises of bars and restaurants . There was no data submitted by the 
applicant in its dossier showing the sufficient risk reduc tion potential of such a 
measure . Data with respect to the in -house drinking water consumption of the general 
public versus outside the house (for example in restaurants and bars) or with respect to 
infants is lacking . There is no direct link between a war ning given on the label, 
indicating that the impregnated water filter is for use in restaurants  and bars  only, and 
the objective of the measure (preventing the consumption by infants of drinking water 
which has passed through an impregnated filter).  The Commission initiated a further 
consultation of Member States representatives on the matter in the Standing 
Committee on Biocidal Products , which further discussed the opinion of ECHA  and 
additional arguments brought forward by the applicant  on 3 May 20 23. Member States 
representatives agreed with the opinion of ECHA and the Standing Committee on 
Biocidal Products concluded that there was not enough evidence to confirm that the 
risk mitigation measure proposed by the applicant would be sufficient to ensu re that 
the risk to infants would be acceptable, while it could not identify any other adequate 
measure to mitigate the risk for infants for the use of water filters treated with silver 
zinc zeolite . 
(7) In conclusion, unacceptable risks to human health are id entified for each of the 
example uses of the representative biocidal product submitted in the application, and 
no safe use could be identified. Therefore, biocidal products of product -type 4 
containing silver zinc zeolite are not expected to satisfy the cr iterion set out in Article 
5(1), point (b) (iii) of Directive 98/8/EC read in conjunction with Article 10(1) of that 
Directive.  
                                                 
4 Biocidal Products Committee  Opini on on the application for approval of the active substance : silver 
zinc zeolite , Product type: 4, ECHA/BPC/ 275/2021, a dopted on 3 March 2021.   
EN 3  EN (8) Silver zinc zeolite has also been assessed pursuant to  Regulation (EC) No 1935/2004  
of the European Parliament and of the Counc il5. The European Food Safety Authority  
(‘EFSA’) adopted an opinion  on 29 March 20056 evaluating  the safety of silver zinc 
zeolite A ( i.e. silver -zinc sodium alumino silicate calcium metaphosphate  with a silver 
content of 1-1.6 % and silver -zinc sodium magnesium alumino silicate calcium 
phosphate  with a  silver content of 0.34-0.54 %) for use in  plastic  food contact 
materials . That opinion  concluded that  a restriction of 0.05 mg/kg of food (as silver) 
for silver zinc zeolit e A would limit the intake to less than 13% of the human no 
observed adverse effect level , and therefore proposed  a group -specific migration limit 
of 0.05 mg Ag/kg food  with certain additional restrictions . Although  silver zinc zeolite 
A has not been  authorised for use in plastic food contact materials at Union level, it 
has been included in a provisional list of additives which can be used in plastic food 
contact materials  subject to national law, in accordance with Article 6(5) of 
Commission Regulat ion (EU) No 10/20117. 
(9) In the context of the evaluation  of silver compounds  under Regulation (EU) No 
528/2012 , EFSA and ECHA  issued a joint document8 in February 2020  (the ‘joint 
EFSA -ECHA document’) , in which they conclude that their respective  opinions for 
the use of s ilver compounds  in food contact materials  are consistent within Regulation 
(EC) No 1935/2004  and Regulation (EU) No 528/2012 , respectively, and that the 
differen ces in the  risk assessment conclusions  in their respective opinions  are due to 
different objectives , datasets and methodologies.   
(10) Taking into account the opinion of ECHA , as well as the joint EFSA -ECHA 
document , it is appropriate not to approve silver zinc zeolite  as an active substance for 
use in biocidal products of product -type 4. 
(11) 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 zinc zeolite (CAS No: 130328 -20-0) is not approved as an active substance for use in  
biocidal products of product -type 4. 
                                                 
5 Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on 
materials and a rticles intended to come into contact with food and repealing Directives 80/590/EEC and 
89/109/EEC (OJ L 338, 13.11.2004, p. 4). 
6 Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact 
with food (AFC) on a  request from the Commission related to a 7th list of substances for food contact 
materials (Question N° EFSA -Q-2003 -076, EFSA -Q-2004 -144, EFSA -Q-2004 -166, EFSA -Q-2004 -
082, EFSA -Q-2003 -204, EFSA -Q-2003 -205, EFSA -Q-2003 -206) adopted on 29 March 2005 by writ ten 
procedure. The EFSA Journal (2005)201, 1 -28. 
7 Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended 
to come into contact with food (OJ L 12, 15.1.20 11, p. 1). 
8 Joint EFSA – ECHA document of February 2020.  Comparison of the evaluations performed on silver 
compounds used as biocidal active substances in food contact materials (FCM) by EFSA and ECHA.   
EN 4  EN 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