European Union Rejects Silver Sodium Hydrogen Zirconium Phosphate as Biocidal Active Substance

Strategic Insights -

The European Commission has issued a decision rejecting the approval of silver sodium hydrogen zirconium phosphate (SSZP) as a biocidal active substance for use in biocidal products of product-type 4, following a thorough evaluation by the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA). The decision, which takes effect on the twentieth day following its publication in the Official Journal of the European Union, cites concerns over the substance's efficacy and potential risks to human health.

Key Takeaways:

  • The European Commission has rejected the approval of SSZP as a biocidal active substance for use in biocidal products of product-type 4, citing concerns over efficacy and human health risks.
  • The decision follows a thorough evaluation by the ECHA and EFSA, which concluded that sufficient efficacy has not been demonstrated for the use of SSZP in food contact materials.
  • The ECHA's opinion, adopted on 3 March 2021, found that biocidal products of product-type 4 containing SSZP would not satisfy the criterion set out in Article 19(1), point (b)(i), of Regulation (EU) No 528/2012.
  • The EFSA's opinion, adopted in 2004, concluded that a restriction of 0.05 mg/kg of food (as silver) for SSZP would limit the intake to less than 12.5% of the human no observed adverse effect level.
  • The joint EFSA-ECHA document, issued in February 2020, concluded that the differences in risk assessment conclusions between the two agencies were due to different objectives, datasets, and methodologies.
  • The decision is in accordance with the opinion of the Standing Committee on Biocidal Products, and will enter into force on the twentieth day following its publication in the Official Journal of the European Union.

Statistics:

  • The evaluation of SSZP by the ECHA was completed on 3 March 2021.
  • The EFSA's opinion on SSZP was adopted in 2004.
  • The joint EFSA-ECHA document, issued in February 2020, found that the differences in risk assessment conclusions between the two agencies were due to different objectives, datasets, and methodologies.
  • The proposed restriction of 0.05 mg/kg of food (as silver) for SSZP would limit the intake to less than 12.5% of the human no observed adverse effect level.
  • The decision will enter into force on the twentieth day following its publication in the Official Journal of the European Union.

Sources:

  • COMMISSION IMPLEMENTING DECISION (EU) 2023/2052 of 25 September 2023
  • Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012
  • Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014
  • 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, adopted on 3 March 2021
  • Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004
  • EFSA Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food, 2004. Opinion of the Scientific Panel on Food Additives & 4th list of substances for food contact materials. EFSA Journal 2004; 2(6):65a, 17 pp. doi:10.2903/j.efsa.2004.65a
  • 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