EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/698 
(POOL/E4/2023/698/698 -EN.docx)  
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
not approving silver sodium hydrogen zirconium phosphate 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 sodium hydrogen zirconium phosphate 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 Un ion, 
Having regard to 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 sodium hydrogen zirconium phosphate (EC No: 422-
570-3; CAS No : 265647 -11-8) for product -type 4 . 
(2) Sweden was designated as the rapporteur Member State. Silver sodium hydrogen 
zirconium phosphate  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 Regulation (EU) 
No 528/2012.  
(3) On 12 June 2017, the evaluating competent authority submitted the assessment report 
on the application together with the conclus ions 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 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 528/2012 of the European Parliament a nd 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 competent  authority . 
(5) It results from the conclusions of the opinion of ECHA that sufficient efficacy has not 
been demonstrated for the use consisting in the incorporation of the reference biocidal 
product into food contact materials. Therefore, biocidal products of  product -type 4 
containing silver sodium hydrogen zirconium phosphate are not expected to satisfy the 
criterion set out Article 19(1), point (b)(i), of Regulation (EU) No 528/2012.  
(6) ECHA also concludes that unacceptable risks for human health have been iden tified 
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 products of product -type 4 containing silver sodium hydrogen 
zirconium phosphate are not expected to satisfy the criterion set out Article 19(1), 
point (b)(iii), of Regulation (EU) No 528/2012.  
(7) Silver sodium hydrogen zirconium phosphate has been also assessed pursuant to  
Regulation (EC) No 1935/2004  of the European Parl iament and of the Council4. The 
European Food Safety Authority  (‘EFSA’) adopted an opinion  evaluating the safety of 
silver sodium hydrogen zirconium phosphate  for use in  plastic  food contact materials  
on 26 May 20045. In that opinion , EFSA  concluded that  a restriction of 0.05 mg/kg of 
food (as silver) for silver sodium hydrogen zirconium phosphate would limit the intake 
to less than 12.5% of the human no observed adverse effect level , and therefore 
proposed  a group -specific migration limit of 0.05 mg Ag/kg  food.  Although silver  
sodium hydrogen zirconium phosphate  has not been  authorised for use in plastic food 
contact materials at U nion 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 10/20116. 
(8) In the context of the evaluation  of silver compounds under Regulation (EU) No 
528/2012 , EFSA and ECHA  issued a joint document7 in February 2020  (‘joint EFSA -
ECHA document’) , in which they conclude that their respective  opinions for the use of 
silver compounds  in food contact materials  are consistent within Regulation (EC) No 
1935/2004  and Regulation (EU) No 528/2012 , respectively, and that the di fferen ces in 
the risk assessment conclusions  in their respective opinions  are due to different 
objectives , datasets and methodologies.   
(9) Taking into account the opinion of ECHA , as well as the joint EFSA -ECHA 
document , it is appropriate not to approve silver sodium hydrogen zirconium 
phosphate as an active substance for use in biocidal products of product -type 4. 
                                                 
3 Biocidal Products Committee  Opinion on the application for approval of the active substance : silver 
sodium hydrogen zirconium phosphate , Product type: 4, ECHA/BPC/ 278/2021, a dopted on 3 March 
2021.  
4 Regula tion (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). 
5 EFSA Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food, 
2004. Opinion of the Scientific Panel on Food Additives a 4th list of substances for food contact 
materials. EFSA Journal 2004; 2(6):65a, 17 pp. doi:10.2903/j.efsa.2004.65a . 
6 Comm ission 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). 
7 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 3  EN (10) 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 sodium hydrogen zirconium phosphate (EC No: 422-570-3; CAS No: 265647 -11-8) 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