In a significant regulatory decision, the European Commission has announced the non-approval of silver zeolite (CAS No: 130328-18-6) as an active substance in biocidal products of product-type 4. This decision, formalised under Commission Implementing Decision (EU) 2023/2648 dated 27 November 2023, follows a comprehensive evaluation process concerning the safety and efficacy of silver zeolite in various applications.
Background and Evaluation Process
Silver zeolite was initially listed for evaluation under Commission Delegated Regulation (EU) No 1062/2014 for potential approval in biocidal products. The evaluation, led by Sweden's competent authority, focused on its use in food and feed area disinfectants and water filters. However, the European Chemicals Agency (ECHA), after thorough examination and consultations, raised significant concerns.
Concerns Raised by ECHA
Inadequate Efficacy in Food Contact Materials: The assessment indicated that silver zeolite, when incorporated into polymers for food contact, failed to demonstrate sufficient efficacy.
Unacceptable Health Risks: ECHA identified considerable health risks associated with the consumption of food in contact with treated polymers, particularly for infants consuming water filtered through materials containing silver zeolite.
Ineffective Risk Mitigation Measures: Proposed measures, like restricting the use of treated water filters to non-residential settings and mandatory labelling, were deemed insufficient in reducing the risk to acceptable levels.
Regulatory Implications and EFSA's Role
The European Food Safety Authority (EFSA) previously evaluated silver zeolite for use in plastic food contact materials, setting specific migration limits for silver ions. However, the current decision underlines a divergent risk assessment under Regulation (EU) No 528/2012. This highlights the complexity and evolving nature of assessing chemical substances across different applications and regulatory frameworks.
Key Takeaways for Stakeholders
Regulatory Compliance: Manufacturers and businesses must be aware of this decision and adjust their product formulations and strategies accordingly.
Risk Management: The decision underscores the importance of thorough risk assessment and mitigation strategies in the development and use of biocidal products.
Continued Vigilance: This decision is a reminder for all stakeholders in the chemical and biocidal product industries to stay informed about regulatory changes and emerging safety data.
