ECHA's 2024-2028 Strategy: Tackling Key Regulatory Challenges in Chemical Safety
This strategy aims to advance chemical safety through science, collaboration, and knowledge, emphasising the protection of human health and the environment.
The European Commission has officially approved silver zinc zeolite as an active substance for use in biocidal products of product types 2, 7, and 9, effective from 1 March 2026. This decision, published on 3 October 2024, aims to enhance the safety and efficacy of biocidal products, particularly those used in disinfectants, film preservatives, and fibre treatment. The approval is governed by Regulation (EU) No 528/2012, with strict conditions for its market use, especially concerning its contact with human skin.
Silver Zinc Zeolite Approval Background
Following a thorough evaluation, the European Commission has granted approval for silver zinc zeolite (CAS No: 130328-20-0) under Commission Implementing Regulation (EU) 2024/2635. The substance, previously listed in Delegated Regulation (EU) No 1062/2014, underwent an extensive review process led by Sweden as the rapporteur Member State. The European Chemicals Agency's (ECHA) Biocidal Products Committee provided key opinions that informed the Commission’s decision. The regulation ensures compliance with Article 5(1) of Directive 98/8/EC, taking into account exposure risks and efficacy.
Key Uses and Product Types
Silver zinc zeolite has been approved for three specific biocidal product types:
- Product Type 2: Disinfectants and algaecides (excluding direct application to humans or animals).
- Product Type 7: Film preservatives to protect surfaces from microbial growth.
- Product Type 9: Preservatives for materials such as fibre, leather, rubber, and polymers.
Conditions and Restrictions
Although silver zinc zeolite offers enhanced antimicrobial properties, its approval comes with critical restrictions. Products using this substance must adhere to strict guidelines, particularly concerning human skin contact. Non-textile polymers treated with silver zinc zeolite must not be placed on the market if they come into contact with skin areas exceeding 300 cm² for adults and children, and 200 cm² for toddlers and infants.
Additionally, the regulation prohibits the use of silver zinc zeolite-treated textiles in scenarios where they may be mouthed by children under two years old, handled in wet conditions, or used outdoors. These conditions ensure that risks associated with prolonged exposure are minimised.
Compliance and Market Implications
To facilitate compliance, the regulation allows a transitional period for the industry, giving manufacturers until March 2026 to adapt to the new requirements. During this period, companies must ensure that treated articles and products incorporate proper labelling, as stipulated by Regulation (EU) No 528/2012. This includes specifying precautionary measures and appropriate usage instructions to safeguard consumers.
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