EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/697  
(POOL/E4/2023/697/697 -EN.docx)  
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
not approving silver 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 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 to Regula tion (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 zeolite (CAS No : 130328 -18-6) for product -type 4 . 
(2) Sweden was designated as the rapporteur Member State. Silver 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 
referre d 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 contam ination of pathogens and the incorporation into materials used in water 
filters to control the growth of bacteria . 
(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 meeting s. 
(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 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 
                                                 
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 528/2 012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, 
p. 1).  
EN 2  EN Committee adopted the opinion of ECHA  on 3 March 20213, having regard to the 
conclusions of the evaluating compet ent authority . 
(5) It results from the conclusions of the opinion of ECHA that , concerning the 
incorporation of silver 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 mitigate those risks.    
(6) As regards the incorporation of sil ver 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 zeolite . The applicant proposed a risk 
mitigation measure  in order to ensure that infants would not be exposed to silver 
zeolite above the acceptable threshold , namely to restrict the use of treated water 
filters to commercial, hospitality and institutional establishments and prohibit 
residential use, including a lso 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 zeolite via the consumption of 
filtered drinking water in res taurants 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 reduction 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 warning 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 State s 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 2023 . Member States 
representatives agreed with the opinion of EC HA and the Standing Committee on 
Biocidal Products concluded that there was no t enough  evidence to confirm that the  
risk mitigation measure proposed by the applicant would be sufficient to ensure 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 
zeolite . 
(7) In conclusion, unacceptable risks to human health are identified 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 zeolite are not expected to satisfy the criteri on set out in Article 
19(1), point (b) (iii), of Regulation (EU) No 528/2012.  
(8) Silver zeolite has been also assessed pursuant to  Regulation (EC) No 1935/2004  of the 
European Parliament and of the Council4. The European Food Safety Authority  
                                                 
3 Biocidal Products Committee  Opinion on the application for approval of the active substance : silver 
zeolite , Product type: 4, ECHA/BPC/ 276/2021, a dopted on 3 March 2021.  
4 Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on 
materials and articles 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).  
EN 3  EN (‘EFSA’) adopted two opinions  on 29 March 20055 and on 4 February 20116 
evaluating  the safety of silver zeolite A (silver zinc sodium ammonium alumino 
silicate),  with a  silver content  of 2–5 %, for use in  plastic  food contact materials . In 
those opinions , EFSA  concluded that  there is no safety concern for the consumer if 
migration of silver ion s from plastic food contact materials does not exceed a group -
specific migration limit of 0.05 mg Ag/kg food.  Although silver 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 may be used in plastic food contact materials  
subject to national law, in accordance with Article 6(5) of Commission Regulation 
(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 consi stent 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 zeolite  as an active substance for use 
in biocidal products of product -type 4. 
(11) The measures provided for in this Decision are in accor dance with the opinion of the 
Standing Committee  on Biocidal Products , 
HAS ADOPTED THIS DECISION:  
Article 1  
Silver zeolite (CAS No: 130328 -18-6) is not approved as an active substance for use in 
biocidal products of product -type 4. 
                                                 
5 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 written 
procedure . The EFSA Journal (2005)201, 1 -28. 
6 EFSA Panel on food contact materials, enzymes, flavourings and processing aids (CEF); Sc ientific 
Opinion on the safety evaluation of the  substance, silver zeolite A (silver zinc  sodium ammonium 
alumino silicate), silver content 2 – 5 %, for use in food contac t materials. EFSA Journal 
2011;9(2):1999. [12 pp.]  doi:10.2903/j.efsa.2011.1999.  
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