In Türkiye, analysis of biocidal products before being placed on the market is a legal requirement under the Biocidal Products Regulation. Biocidal product analyses contribute to the protection of human health and the environment.
Since biocidal products are used to destroy, neutralize, or prevent the spread of harmful organisms, they may pose potential risks. Therefore, they must be subject to strict control. In this context, under the Regulation, biocidal products must undergo analytical testing to demonstrate their efficacy, safety, stability and compliance with the regulatory standards set by the Turkish Ministry of Health (MoH).
Chemleg’s Biocidal Product Analysis Support ensures that your products meet all necessary testing requirements for successful licensing and market approval in Türkiye.
Legal Framework for Biocidal Product Analysis in Turkey
The Regulation governing the analysis of biocidal products is Biocidal Products Regulation Official Gazette No: 27449 (4th bis). The key elements are as follows:
- Licensing requirement
To place a biocidal product on the Turkish market, a license must be obtained from the Ministry of Health of the Republic of Türkiye. This process requires the submission of specific product data and involves a comprehensive evaluation. Chemleg can also assist you in the licensing of your biocidal products. - Testing requirement and authorized laboratories
The analysis reports submitted during the licensing application must be prepared by laboratories authorized by the Ministry of Health.
The analyses must demonstrate the product’s compliance with the declared content and efficacy.
- Liability and penalties
Administrative fines and other sanctions may be imposed in cases such as placing non-compliant products on the market or producing counterfeit or unlicensed products. If the Ministry of Health identifies non-compliance during inspections of samples taken from the market, it may also order the withdrawal of the products.
Why You Need Expert Support
- All documents submitted for regulatory compliance must be in Turkish.
- Physicochemical analysis, accelerated and long-term stability analyses of the biocidal product must be conducted in an accredited laboratory in TR. Efficacy tests conducted abroad may be submitted as part of the application if they meet certain criterias under TR BPR. If not, the efficacy analysis must also be conducted in an accredited laboratory in TR.
- The processes are complex and require compliance not only with the Biocidal Products Regulation but also with other local legislation.
- With services such as Only Representation and dossier preparation, Chemleg helps you achieve full compliance.
How Chemleg Supports Biocidal Product Analysis
Chemleg follows up your biocidal product analysis process from start to finish and manages communication with the laboratory. With Chemleg’s support, you can save both time and cost while ensuring safe market entry of your products in Türkiye.
Our Biocidal Product Analysis Services Include
- Physicochemical & Stability Testing
- Physicochemical Properties Analysis: Assessing parameters such as appearance, color, pH, density
- Storage Stability Testing: Ensuring stability during the shelf life of both unopened and opened packaging
- Efficacy Testing (Performance Evaluation)
- Bactericidal, Virucidal, Fungicidal, and Sporicidal Tests: Demonstrating antimicrobial efficacy
- Insecticide & Rodenticide Efficacy Testing: Evaluating the performance of pest control products
3. Toxicological & Safety Assessments
- Dermal & Eye Irritation/Corrosion Tests for biocidal product under PT 1&19: Assessing potential hazards to skin and eyes
- Environmental Impact Assessments
- Chemical Risk Assessment: Identifying potential environmental hazards
- Residue & Contaminant Analysis
- Heavy Metal & Impurity Testing: Ensuring compliance with safety limits
- Active Ingredient Content Verification: Confirming declared composition
- Compliance with Turkish & International Standards
- EN Standards for Biocidal Products: Ensuring testing is carried out in line with EU and Turkish norms
- GLP-Compliant Laboratory Testing: Collaborating with accredited laboratories for reliable results
- Dossier-Ready Analytical Reports: Delivering regulatory-compliant reports for submission
Why Choose Us?
- Expert Guidance on Test Requirements: Tailored recommendations for your product category
- Accredited Laboratory Partnerships: Collaborations with GLP-certified and MoH-approved laboratories
- Regulatory Compliance Focus: Ensuring test results meet Turkish Biocidal Product Licensing requirements
Fill out the form and ensure your biocidal products pass all required analyses with our expert testing support services.
Frequently Asked Questions
Why is biocidal product analysis mandatory?
Due to their nature, biocidal products may pose potential risks to human health and the environment. Analyses are required to ensure these products remain within legal limits, demonstrate declared efficacy, and can be used safely.
How are analysis results used in the licensing process?
The analysis results serve as fundamental evidence that the biocidal product has the declared content and efficacy. The Ministry of Health reviews these reports when deciding on the licensing of the product.
Is further analysis required after obtaining a license?
Yes. The Ministry of Health conducts regular inspections by randomly collecting samples of licensed products from the market. These inspections aim to verify compliance with the standards and declarations made during the licensing stage. Products found non-compliant may be withdrawn from the market, and administrative fines may be imposed on the companies concerned.
