Diario Oficial de la Unión Europea del 26/9/2023 - Sección Legislación
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Fuente: Diario Oficial de la Unión Europea - Sección Legislación
26.9.2023
EN
Official Journal of the European Union
L 236/41
7
Silver sodium hydrogen zirconium phosphate has been also assessed pursuant to Regulation EC No 1935/2004 of the European Parliament and of the Council 4. 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 2004 5. 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 65 of Commission Regulation EU No 10/2011 6.
8
In the context of the evaluation of silver compounds under Regulation EU No 528/2012, EFSA and ECHA issued a joint document 7 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:
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, 25 September 2023.
For the Commission The President Ursula VON DER LEYEN
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.
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; 26:65a, 17 pp. doi:10.2903/j.efsa.2004.65a.
6 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, 15.1.2011, 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.
