In a recent implementing decision (EU) 2023/2622, the Commission has not approved silver zinc zeolite (CAS No: 130328-20-0) as an active substance for use in biocidal products of product-type 4. This decision, taking effect twenty days post-publication in the Official Journal of the European Union, aligns with the stringent safety and regulatory frameworks governing biocidal products in the EU.
Background of the Decision
Silver zinc zeolite was under evaluation for possible approval in food and feed area disinfectants, a category falling under product-type 4. These products are essential in maintaining hygiene standards, especially in settings where food is prepared and stored. The safety assessment process involved the European Chemicals Agency (ECHA), the Biocidal Products Committee, and the competent authority of Sweden as the rapporteur Member State.
Key Findings Leading to Non-Approval
Two primary applications of silver zinc zeolite were under scrutiny:
- Incorporation into Polymers for Food Contact Materials: The evaluation concluded that the efficacy of silver zinc zeolite in this application was not sufficiently demonstrated. Moreover, significant risks to human health were identified, particularly due to the consumption of food in contact with treated polymers. The absence of effective risk mitigation measures further influenced the decision.
- Use in Water Filters: The Commission identified unacceptable risks to infants consuming water filtered through materials treated with silver zinc zeolite. Proposed risk mitigation measures, including restricted usage and mandatory labelling, were deemed insufficient. Concerns revolved around the potential exposure of infants to silver zinc zeolite beyond acceptable thresholds.
Broader Regulatory Context
This decision is part of the EU's ongoing efforts to ensure the highest safety standards for products that come into contact with food and are involved in hygiene maintenance. The European Food Safety Authority (EFSA) has previously evaluated silver zinc zeolite for use in plastic food contact materials. The Commission's decision aligns with the broader regulatory framework of the EU, ensuring consistency across various directives and regulations, including Regulation (EU) No 528/2012 and Regulation (EC) No 1935/2004.
Implications for Stakeholders
Manufacturers and users of biocidal products must now reconsider the composition of their products, especially those in product-type 4. The decision highlights the need for rigorous evaluation of active substances in biocidal products and the importance of meeting the EU's stringent safety standards. Companies should explore alternative substances that comply with EU regulations while ensuring the effectiveness and safety of their products.
The European Commission's decision not to approve silver zinc zeolite as an active substance in biocidal products underscores the EU's commitment to public health and safety. This decision serves as a reminder to all stakeholders in the biocidal product sector to prioritise safety and regulatory compliance in their product development and usage.
In a recent implementing decision (EU) 2023/2622, the Commission has not approved silver zinc zeolite (CAS No: 130328-20-0) as an active substance for use in biocidal products of product-type 4. This decision, taking effect twenty days post-publication in the Official Journal of the European Union, aligns with the stringent safety and regulatory frameworks governing biocidal products in the EU.
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