European Union Refuses Authorization of CIT for Biocidal Products
On February 24, 2025, the European Union (EU) issued Commission Implementing Decision (EU) 2025/357, denying authorization for 5-chloro-2-methyl-2H-isothiazol-3-one (CIT) as an active substance in biocidal products of product-type 6, which pertains to preservatives intended to inhibit microbial growth during storage.
Background
The European Chemicals Agency (ECHA) received the application for the approval of CIT on August 22, 2017. The substance is commonly utilized in various applications, including cosmetics, paints, and industrial water treatment, serving primarily as a biocide to prevent microbial contamination. However, regulatory scrutiny revealed significant gaps in the data regarding its potential endocrine-disrupting properties.
Key Events
The application underwent multiple assessments, highlighting the longstanding complexities associated with establishing the safety of chemical substances. In June 2020, the Biocidal Products Committee determined that the applicant had not sufficiently demonstrated that CIT's use would not adversely affect non-target organisms.
In December 2022, the applicant submitted further data, which prompted a revised assessment. However, the evaluating competent authority ultimately concluded in September 2023 that the provided information still failed to conclusively rule out endocrine-disrupting properties.
Following the ECHA's opinion, the EU Commission deemed that without robust evidence, granting approval for CIT would be inappropriate, culminating in the formal denial of its use in Type 6 biocidal products.
Final Decision
This decision enters into force 20 days following its official publication, marking an important step in regulating chemical substances within the EU to ensure public safety and environmental protection.
Take Action
For brands, retailers, and manufacturers navigating the complexities of chemical regulations, this decision underscores the importance of comprehensive data in compliance efforts. Check out our chemical testing solutions to stay compliant.
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