Microbiological and Biological Analyses in Biocidal Products: Updated Evaluation Guide
The safety and efficacy of biocidal products are of great importance for both public health and environmental protection. In this context, the licensing and authorization processes of biocidal products in Turkey are carried out in accordance with the Biocidal Products Regulation No. 27449, published on December 31, 2009. However, new regulations have been introduced to standardize product analyses and improve the efficiency of laboratory processes.
New Guide for Microbiological and Biological Analyses
Published on October 27, 2025, the “Evaluation Guide for Microbiological/Biological Analyses” aims to standardize the microbiological and biological analysis processes for biocidal products. According to this guide, laboratories are required to meet infrastructure, validation, method standardization, and personnel training requirements, while applicants must conduct analyses and efficacy tests in accordance with the guide.
The new guide replaces the previously used “Directive on Biocidal Product Analyses and Authorized Laboratories.” Additionally, the following documents have been published to regulate laboratory authorizations according to product types:
Biological Efficacy Laboratory Authorization Directive for Product Types 14-18-19
Physical, Chemical, and Stability Test Analysis Guide for Biocidal Products
Transition Period and Licensing Arrangements
To ensure uninterrupted implementation of the new guide, a transition period has been planned. Accordingly:
For products licensed based on short-term stability tests with ongoing long-term stability tests, efficacy test results must be submitted in accordance with the guide upon completion of the long-term tests.
New applications and ongoing licensing processes must comply with the guide’s requirements.
During this transition period, valid licenses can be issued up to December 31, 2026.
Important Points for Laboratories and Sector Stakeholders
It is crucial that laboratories and sector stakeholders complete the necessary preparations regarding infrastructure and procedures as outlined in the guide. Key points include:
Infrastructure and Equipment: Laboratories must have the necessary devices and equipment to accurately perform biological efficacy tests.
Method Standardization: Test methods should be standardized in line with the guide’s specifications.
Personnel Training: Staff must be trained to carry out analyses accurately and reliably according to the guide.
Innovations Introduced by the Guide
The new guide aims to enhance the safety of biocidal products, standardize analysis procedures, and improve laboratory expertise. It is critical that applicants and laboratories pay close attention to the transition period to ensure both regulatory compliance and product safety.
These regulations will increase quality and safety in biocidal products, providing long-term benefits for both the sector and public health.