BIOCIDAL PRODUCT LICENSING IN TURKIYE
Content addition date : 26-08-2025
In Turkey, biocidal products must be licensed by the Ministry of Health before they can be placed on the market. This process ensures that the product is both safe and effective. All licensing procedures are carried out electronically through the Product Tracking System (ÜTS).
Licensing Process 3 Key Stages:
1️⃣ Analysis and Testing Phase
The licensing dossier must include the following test results:
- Physicochemical tests: Determine the product’s physical and chemical properties
- Stability tests: Assess shelf life and durability (accelerated and long-term)
- Opened package stability test: Evaluate product degradation after opening (Tests requested only for the disinfectant group)
- Efficacy tests: Demonstrate effectiveness against target microorganisms
These tests must be conducted in authorized laboratories within Turkey. For imported products, foreign test results may be accepted under specific conditions. The Ministry of Health accepts analyses from laboratories that have completed and documented the Accreditation Certificate, GLP (Good Laboratory Practices Certificate) or Validation/Verification.
2️⃣ Documentation and Technical Files
Applicants must prepare and submit the following documents:
- Safety Data Sheet (SDS)
- Label design (in compliance with Annex-XII)
- Formulation and specification documents
- Active substance dossier (Annex-IIA compliant)
- Product dossier (Annex-IIB compliant)
- Toxicological and ecotoxicological risk assessment report (as per Annex-VI)
These documents provide detailed information on product safety, environmental impact, and usage instructions.
3️⃣ Application via ÜTS and Evaluation
- Applications are submitted through the ÜTS Biocidal Products Module
- If deficiencies are found, the system notifies the applicant via system message and email
- Applicants are given three chances to correct deficiencies. If not resolved within the timeframe, the application is cancelled
- Products that meet all regulatory requirements are granted a license
Special Cases and Exceptions
- Product Type 1 (Human Hygiene) and Product Type 19 (Repellents and Attractants) do not require pre-application or sample collection by Provincial Health Directorates
- Samples must be delivered to designated laboratories for testing
Active Substance Approval
Active substances used in biocidal products are evaluated based on two lists:
- List 1: Substances officially “approved”
Substances rejected by the EU are also removed from Turkey’s lists. (Biocidal Products Regulation – Article 12)
List 1A: “Low Risk” active substances (Biocidal Products Regulation – Article 13)- Not included in List 1 and List 1A: List of active substances not included in List 1 and List 1A of the Regulation (Biocidal Products Regulation – Article 14)
Conclusion
Licensing biocidal products is a critical process for protecting public health and environmental safety. Manufacturers and importers must navigate this process carefully to ensure legal compliance and product reliability.
You can get support from CRAD's professional team regarding the management of the licensing process of your biocidal products.