Contents
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 Council of 22 May 2012 concerning the making available on the market and use of biocidal productsnote, and in particular Article 89(1), third subparagraph, thereof,Whereas:
(1)Commission Delegated Regulation (EU) No 1062/2014note establishes a list of existing active substances 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 conclusions of its evaluation to the European Chemicals 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 Committee adopted the opinion of ECHA on 3 March 2021note, 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 representative 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 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 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 Parliament and of the Councilnote. 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 2004note. 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 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 10/2011note.
(8)In the context of the evaluation of silver compounds under Regulation (EU) No 528/2012, EFSA and ECHA issued a joint documentnote 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 differences 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.
(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:
Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.