Biocidal Products Compliance
In Türkiye, biocidal products are regulated by the Biocidal Products Regulation of the Ministry of Health, published in the Official Gazette of 31 December 2009 (No. 27449, 4th repeated issue). The Regulation was prepared in line with EU Directive 98/8/EC, which has since been replaced in the EU by Regulation (EU) No 528/2012, applicable from 1 September 2013.
Doruksistem Services for Biocidal Products in Türkiye
Placing biocidal products on the Turkish market requires a valid licence (ruhsat) and full compliance with the Regulation. Doruksistem supports manufacturers and importers throughout the licensing process, from dossier preparation to submission and follow-up.
Understanding the Turkish Biocidal Products Regulation
The Biocidal Products Regulation sets out the procedures for the licensing, registration, classification, packaging, labelling and inspection of these products, taking into account their potential effects on human health and the environment.
Competent authorities
- Product types 1 and 19 (human hygiene products and repellents/attractants) in direct contact with the human body: Turkish Medicines and Medical Devices Agency (TİTCK). Since 9 December 2021, licence applications for these products have been submitted through the ÜTS Biocidal Module.
- Other product types: Ministry of Health, General Directorate of Public Health.
Recent amendments
The amendment published in Official Gazette No. 31705 of 30 December 2021 brought the procedures closer to EU practice. Among other changes, it abolished the preliminary application and sealed sampling step, introduced a QR code on labels for traceability, and provided for biological efficacy analyses of pest control products to be carried out in laboratories authorised by the Ministry.
The Licensing Process for Biocidal Products in Türkiye
Before a product can be placed on the market, the applicant must prepare a complete dossier in Turkish, submit it to the competent authority and respond to any requests for additional information until the licence is granted.
How Doruksistem Supports Your Licence Application
1. Preparation of application documents
- Biocidal product dossier in line with Annex IIB
- Active substance dossier in line with Annex IIA, including safety, toxicology and ecotoxicity data
- Product label in line with the Regulation, including the required warnings
- Safety data sheet (SDS) in line with Annex II of KKDİK
- Formulation and specification documents
- Risk assessment report
- Review of existing test reports and, where needed, coordination of tests in Türkiye or abroad
- Literature review and translation of foreign-language documents into Turkish
We also advise on product type classification and label content, so that the dossier is consistent from the start.
2. Submission and follow-up
- Submission of the application dossier to the competent authority
- Regular follow-up of the application and prompt responses to deficiency letters
- Support until the licence is granted, and information on new regulatory requirements after licensing
Frequently Asked Questions
Which regulation governs biocidal products in Türkiye?
The Biocidal Products Regulation published in the Official Gazette of 31 December 2009 (No. 27449, 4th repeated issue), as amended. Related legislation includes the Communiqué on Biocidal Products without Active Substances and the Communiqué on Articles Treated with Biocidal Products.
Who issues the licences?
TİTCK for product types 1 and 19 in direct contact with the human body, and the Ministry of Health’s General Directorate of Public Health for other product types.
Is a safety data sheet required?
Yes. A safety data sheet prepared in line with Annex II of KKDİK is one of the key documents in licence and registration applications for these products and their active substances.
How does Doruksistem help?
We prepare the Annex IIA and IIB dossiers, labels, safety data sheets and supporting documents, coordinate testing where needed, submit the application and follow it up until the licence is granted.