You can click the link below to access the Turkish Biocidal Products Regulation:
Turkish Biocidal Products Regulation No. 27449
What Is the Turkish Biocidal Products Regulation?
The Biocidal Products Regulation is the legal framework governing the procedures and principles for the manufacture, import, authorisation, registration, packaging, labelling, classification and inspection of biocidal products in Türkiye before they are placed on the market, in a manner that enables the assessment of risks to human health, animal health and the environment.
Requirements of the Biocidal Products Regulation in Türkiye
- Biocidal products intended to be placed on the Turkish market must be authorised or registered.
- Applications for the authorisation of biocidal products may only be submitted by natural or legal persons established in Türkiye or having a representative in Türkiye.
- The active substances contained in a biocidal product must be included in the active substance lists specified for the relevant product type and permitted by the Ministry.
- Biocidal products must be classified and packaged in accordance with the Regulation on the Classification, Labelling and Packaging of Substances and Mixtures (SEA Regulation).
- Biocidal product labels must be prepared in accordance with the Annex-XII under the Regulation.
- Safety Data Sheets must be prepared for biocidal products in accordance with the provisions of KKDIK.
- Physicochemical analysis, stability and efficacy analyses that must be submitted in the biocidal product dossier. These tests must be conducted in accordance with the principles of Good Laboratory Practice (GLP) or ISO 17025 accredited laboratories.
Biocidal Product Authorisation in Türkiye
Under the Turkish Biocidal Products Regulation, biocidal products must be authorised or registered by the Ministry of Health before they can be placed on the market. Such authorisations and registrations are granted to natural or legal persons established in Türkiye or whose registered office, branch or representative is located in Türkiye.
Authorisation for an assessed active substance (Article 12): Granted to products containing a new active substance or assessed active substances included in List I or List IA. Product licenses can be for 6 or 10 years, depending on the active ingredient status.
Registration of a low-risk biocidal product (Article 13): A registration certificate is issued for products containing active substances included in List IA that pose a low risk to humans, animals and the environment. Product licenses can be for 6 or 10 years, depending on the active ingredient status.
Authorisation/registration for an existing active substance (Article 14): Issued for biocidal products containing existing active substances that fall within the scope of List IA but have not yet been included in List I or List IA. These authorisations are valid for six years. However, if one of the active substances is included in List I or List IA at an earlier date, the validity period is redetermined.
Emergency authorisation/registration (Article 15): Granted for temporary and limited use in unforeseeable emergency situations that cannot be controlled by other means. It is valid for four months.
Frame formulation authorisation/registration (Article 16): Granted for a frame formulation relating to products whose main formulation has already been authorised or registered. Its validity corresponds to that of the main product on which it is based and may not exceed 10 years.
Chemleg Biocidal Product Consultancy
Chemleg helps you place your biocidal products on the Turkish market through its team of experts. Our services in this field include:
- Only representation
- Biocidal product authorisation
- Support with biocidal product analyses
- Risk assessment
Complete the form to obtain further information and arrange a meeting with our experts.
