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Biocidal Product Application Principles
BPR (TR)
General Principles for the Application for Licensing of Biocidal Products
Biocidal Product Licensing
What are the types of Biocidal Products?
Biocidal Products; It is evaluated in 4 main groups (23 types).
1. Main group: Disinfectants (Product type 1-5)
2. Main group: Protectors (Product type 6-13)
3. Main group: Pest control products (Product type 14-20)
4. Main group: Other biocidal products (Product type 21-23)
You can contact us for detailed information about product types and descriptions.
What is a biocidal product license?
As stated in the Biocidal Products Regulation:
In order for biocidal products to be placed on the market, they must be licensed or registered according to the procedures determined by the Ministry of Health.
The license is a production permit for domestic products and an import permit for imported products.
The registration certificate is the document showing that a low-risk biocidal product can be placed on the market.
Biocidal products can be placed on the market after they are licensed / registered by the Ministry of Health.
Where to Obtain Biocidal Product License and Application
Process Licensing of biocidal products is carried out by two main institutions in Turkey. These institutions and the types of products they are authorized for are as follows:
- Ministry of Health Turkish Medicines and Medical Devices Agency (Cosmetic Products Department)
Scope of Application: Biocidal products that come into direct contact with the human body, such as Product Type 1 (hand sanitizers, antibacterial liquid soap, etc.) and Product Type 19 (insect repellents applied to the body). - Ministry of Health General Directorate of Public Health (Department of Environmental Health)
Field of Application: Other biocidal products such as ambient, air and surface disinfectants, antibacterial paints, pesticides, wood preservatives.
For Turkish Pharmaceuticals and Medical Devices Agency:
All documents required for your application, such as license file in Annex-IIB format, label, Safety Data Sheet (SDS/MSDS), formulation and specification documents must be prepared and submitted.
For the General Directorate of Public Health:
Similarly, documents in accordance with the regulation should be prepared, risk assessment reports and test results should be included in the file.
Biocidal Product License Application Process and Required Documents
The license application process is made to the General Directorate of Public Health with all the documents prepared in accordance with Articles 12 and 14 of the Regulation. Here are the details about this process and the required documents:
1. File Preparation and Application
You must complete the documents required for the license application. These documents include the formulation of the biocidal product, specification documents, label samples and the Safety Data Sheet (SDS/MSDS). Active substance files must be prepared in accordance with the Annex-IIA format. The information and documents specified in Articles 12 and 14 of the Regulation and the application file, all of which have been completed, are submitted to the Institute.
2. Analyzes and Tests
Samples required for product analysis are taken by the manufacturer or importer according to appropriate procedures and sent to authorized laboratories. Physico-chemical analyses, short-term and long-term stability analyses, Basic analyzes such as effectiveness analysis should be performed.
3. Institutional Evaluation
As a result of the evaluation of the application by the Institution, if there are no deficiencies in the file, the license fee is paid and the licensing process is completed. If there are deficiencies, these deficiencies are reported by the Institution and additional time is given to correct the deficiencies.
4. Additional Requirements for Imported Products
The product formulation for imported products must be approved by the manufacturer. In addition, the technical file must contain the Authorization Certificate issued by the manufacturer for the registration of the product and its notarized Turkish translation.
5. Laboratory Authorization
Studies carried out in laboratories accredited by the Turkish Accreditation Agency (TÜRKAK) and with accredited test and analysis methods or internationally accredited results are accepted. After completing these stages, the label sample and license approved by the Authority for the biocidal product are forwarded to the applicant. If the application is not found suitable, the application will be rejected.
As your consultancy company, Doruksistem, we assist you throughout this process with our expertise and experience. We pay special attention to issues such as preparing appropriate documents and managing testing and analysis processes.
Click here for the General Directorate of Public Health license application process and required documents.
Biocidal Product Licenses: Validity Periods and Renewal Dates
In accordance with the Biocidal Products Regulation (OG 31 December 2009, 27449 (4th duplicate)), procedures regarding the licensing and validity periods of biocidal products are carried out. According to the announcement made by the General Directorate of Public Health, the validity periods of all biocidal product licenses obtained in 2015 expired on 31/12/2021.
Validity Periods and Renewal Dates According to License Issuance Date
License Issue Date: 2 January 2015-30 December 2016:
- Validity Period: 31 December 2022
- Renewal Date: 3 January 2022-30 December 2022
License Issue Date 2 January 2017-29 December 2017:
- Validity Period: 31 December 2023
- Renewal Date: 2 January 2023 -29 December 2023
License Issue Date 1 January 2018-31 December 2018:
- Validity Period: 31 December 2024
- Renewal Date: 2 January 2024-31 December 2024
License Issue Date 2 January 2019-31 December 2019:
- Validity Period: 31 December 2025
- Renewal Date : 2 January 2025-31 December 2025
License Issue Date 1 January 2020-31 December 2020:
- Validity Period: 31 December 2026
- Renewal Date: 2 January 2026-31 December 2026
License Issue Date 2 January 2021-31 May 2021 (Long-term stability tests)
- Validity Period: 31 December 2027
- Renewal Date: 4 January 2027-31 December 2027
License Issue Date 1 June 2021-31 December 2021:
- The validity period will be considered as the period during which the long-term stability tests will be completed.
Status by Active Substance
- List-A: The license validity period for biocidal products containing the active substance will be 6 years.
- List-I: For those whose approval validity period is less than 10 years, up to the approval validity period; For those longer than 10 years, a Biocidal Product License valid for 10 years will be issued.
Products Containing Multiple Active Ingredients
For biocidal products that contain more than one active substance and whose active substances are on different lists, or whose active substances are on the same list, but whose approval validity date is different, the validity period of the licenses should be determined in a way that ensures the shortest period.
BPR (TR) summary
Turkey’s Biocidal Products Regulation represents a significant stride towards establishing a harmonized regulatory framework for biocidal products in alignment with European Union standards. First introduced in 2009, the regulation has since undergone several amendments to enhance its efficacy and scope in managing biocidal products while ensuring robust protection for human health and the environment.
Evolution of Turkish Biocidal Products Regulation
On 31st December 2009, Turkey adopted its initial Biocidal Products Regulation, published in the Official Gazette. This regulation was harmonized with Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market. The aim was to create a synchronized regulatory landscape for biocidal products across the European region.
In 2013, a corrigendum, known as “Biocidal Products No. 28939,” was issued. This was designed to further align the Turkish Biocidal Products Regulation with the EU framework, specifically, EU Regulation 528/2012.
EU Regulation 528/2012, also known as the Biocidal Products Regulation (BPR), replaced the Biocidal Products Directive (BPD), Directive 98/8/EC, as the main regulatory framework for biocidal products in the EU. This move meant that it was necessary for Turkey to revise its regulation to maintain harmonization with the EU.
The most recent amendment to Turkey’s Biocidal Products Regulation was made on 12th March 2020, as published in the Official Gazette No:31066 by the Ministry of Health. Each of these amendments has built upon the previous regulatory framework, refining definitions, and clarifying procedures and obligations, with the goal of enhancing the regulation of biocidal products in Turkey.
The overarching goal of the Turkish Biocidal Products Regulation is to streamline the functioning of the biocidal products market while maintaining a high level of protection for humans and the environment. Biocidal products, by their nature, are designed to control harmful or unwanted organisms, but if not properly managed, they can pose significant risks to human health and the environment.
The regulation requires that biocidal products must be authorized before they can be placed on the market, and sets out the procedures for gaining such authorization. It also outlines obligations for companies involved in the manufacture, import, or sale of biocidal products, and imposes penalties for non-compliance.
By aligning its regulation with the EU’s Biocidal Products Regulation, Turkey has facilitated trade and regulatory cooperation with EU member states. It has also provided clear guidance for Turkish companies, helping them comply with internationally recognized standards for biocidal product management.
As the Turkish Biocidal Products Regulation continues to evolve, its ultimate aim remains the same: to ensure the safe and controlled use of biocidal products, protect public health and the environment, and maintain alignment with international regulatory standards. This progressive approach not only strengthens the country’s biocidal products market but also contributes to global efforts to manage these substances responsibly. As such, understanding the intricacies of this regulation is crucial for any business operating in this sector in Turkey.
The Turkish Biocidal Products Regulation (BPR) forms part of a wider regulatory framework for chemical and substance management in Turkey. Several other key regulations are closely connected to the BPR and play a significant role in shaping Turkey’s approach to chemical safety and management. Here is a detailed analysis of each:
Regulation on Classification, Labelling and Packaging of the Substances and Mixtures (11 December 2013, No. 28848):
This regulation aligns with the European Union’s CLP Regulation (EC No. 1272/2008), and it requires substances and mixtures to be classified based on their hazards. They must be appropriately labeled and packaged before being placed on the market. The regulation ensures that the hazards presented by chemicals are clearly communicated to workers and consumers through a standardized system of classification and labeling, enhancing the safety and health of human lives and protecting the environment.
Regulation on Safety Data Sheets of Dangerous Substances and Mixtures (13 December 2014, No. 29204):
This regulation is harmonized with the EU’s REACH Regulation (EC No. 1907/2006). It requires manufacturers and importers of dangerous substances and mixtures to create Safety Data Sheets (SDS). SDSs provide essential information about the properties, hazards, safe handling, storage, transport, disposal, and emergency procedures related to a substance or mixture. This information helps to protect users and allows for appropriate emergency response.
Instruction on Biocidal Product Analysis and Authorized Laboratories (28 January 2015, No. 19020089-704.99-519):
This instruction outlines the requirements and procedures for the analysis of biocidal products and the authorization of laboratories that conduct these analyses. It ensures the standardization and reliability of the tests performed on biocidal products, which underpin the regulatory controls on their manufacture, sale, and use.
Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (23 June 2017, No. 30105):
Commonly known as the KKDIK regulation, this is Turkey’s equivalent of the EU’s REACH regulation. It requires all chemical substances produced in or imported into Turkey in quantities over one ton per year to be registered with the Ministry of Environment and Urbanization. Manufacturers and importers must submit a registration dossier that includes information about the substance’s properties, uses, classification, and safety measures, including an assessment of the risks posed to human health and the environment.
These regulations, in conjunction with the Turkish Biocidal Products Regulation, provide a comprehensive and harmonized approach to chemical management in Turkey. They work in tandem to control the entire lifecycle of chemicals, from their production or import, through their use and handling, to their disposal. Together, they serve to ensure that chemicals and substances are managed in a way that protects human health and the environment.
As the regulatory landscape for biocidal products becomes increasingly complex in Turkey, companies seek expert guidance to navigate the process and ensure compliance. Our team provides a range of services tailored to assist businesses in meeting the requirements set out by the Turkish Biocidal Product Regulation. Here’s what we offer:
Biocide Regulatory Consultancy and Support:
Our team provides expert advice and guidance on all aspects of the Turkish BPR, helping your business understand the regulatory requirements and strategies for compliance.
Acting as Appointed Only Representative for Non-Turkey Companies:
For foreign companies looking to register their biocidal products in Turkey, we can act as your appointed only representative. This means we handle all local compliance responsibilities on your behalf, acting as the main point of contact with Turkish regulatory authorities.
Label Creation:
We assist in the creation of product labels that are compliant with Turkey’s Biocidal Product Regulation. This includes ensuring the correct classification, labeling, and packaging of your biocidal products.
Inventory Notification Compilation:
Our team can help compile the required inventory notification that details the biocidal products your company is placing on the Turkish market.
Provisional Application Dossier Compilation:
We help businesses compile and submit the provisional application dossier, which is a key requirement of the Turkish Biocidal Product Regulation.
Communication with the Ministry of Health and Accredited Laboratories:
Our team facilitates communication between your business, the Ministry of Health, and accredited laboratories during the sampling and analysis stages. We help coordinate these critical steps to ensure your product approval process goes smoothly.
SDS Authoring for Biocidal Products:
We create Safety Data Sheets (SDS) for your biocidal products in compliance with Turkey’s SDS regulations. An SDS contains vital information about a product’s properties, hazards, safety measures, and handling guidelines.
Data Gap Assessment:
We analyze your existing data and documentation to identify any gaps that need to be addressed before submitting your biocidal product registration dossier.
Compilation of Biocidal Registration Dossier:
Our team assists in compiling a comprehensive registration dossier for your biocidal product as per the requirements of the Turkish Biocidal Product Regulation.
Consultancy on Frame Formulation Structure:
We as DORUKSISTEM offer consultancy services to guide you on the frame formulation structure, ensuring the correct presentation of your biocidal product’s composition, helping streamline the registration process.
We understand that navigating through regulatory processes can be daunting. Our comprehensive suite of services is designed to simplify the Turkish Biocidal Product Regulation process for your business, ensuring seamless and efficient compliance with all regulatory requirements. With our team on your side, you can focus on what matters most: developing and selling your biocidal products. Please contact for our services.
To facilitate understanding of the Turkish Biocidal Product Registration process, let’s break it down into three stages:
Stage 1: Execution of Temporary Application Feasibility
In this preliminary stage, a comprehensive feasibility study is performed to ensure all the necessary data and documents are available for the product registration process.
Biocidal Product Provisional Application Dossier Preparation:
The first step is to compile a provisional application dossier containing all the necessary information about the biocidal product. This includes details on its composition, usage, safety measures, labelling, and packaging.
Submission to Online Portal:
After the dossier is compiled, it is submitted to the Ministry of Health via their online portal. This portal is designed for a streamlined submission and review process.
Application Follow-up:
Once the application has been submitted, it’s essential to follow up on its progress regularly. This process involves tracking the application’s status, responding to any queries from the Ministry, and ensuring the pre-application process is concluded successfully.
Stage 2: Sampling Process of Biocidal Product
The second stage involves getting the biocidal product sampled and analyzed to ensure it meets safety and performance standards.
Selecting an Authorized Laboratory:
The product samples are sent to a laboratory authorized by the Ministry of Health for testing. It is crucial to choose a laboratory that has the capability and accreditation to test biocidal products.
Evaluation and Conformity Check:
The chosen laboratory will perform a scientific evaluation of the product and conduct analyses using methods that are in compliance with Turkish Biocidal Product Regulation.
Sample Sealing and Analysis:
The biocidal product samples are sealed and subjected to a series of tests. During this phase, it’s important to monitor each stage of the analysis closely and resolve any issues promptly to prevent delays.
Stage 3: Licensing Process
The final stage is acquiring the license to place the biocidal product on the Turkish market.
License File Compilation:
All necessary documents for the license are compiled into a comprehensive file. This includes the product’s safety data sheets, analysis reports, and any other required information.
Technical Support:
If necessary, technical support is provided during the evaluation process. This could involve responding to queries from the Ministry or clarifying specific aspects of the product or its analysis.
License Monitoring:
Regularly monitoring the licensing process ensures any potential issues are quickly identified and addressed. Updates on the progress are regularly reported to the licence holder.
Obtaining the Final License:
After all requirements are met and the evaluation process is completed, the final license is issued. With this license, the biocidal product can be legally placed on the Turkish market.
This detailed step-by-step guide provides a roadmap for navigating the Turkish Biocidal Product Registration process. By understanding and adhering to these stages, businesses can ensure a smoother, more efficient registration process, ultimately accelerating their product’s entry into the Turkish market.