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.
In the evolving landscape of biocidal product regulations in Turkey, staying compliant is key to market success. This article delves into the intricacies of the Turkish Biocidal Products Regulation and how DORUKSISTEM, a leading regulatory consultancy, is pioneering compliance and licensing services for businesses looking to navigate this complex terrain.
Historical Overview
Placing biocidal products on the market in Turkey requires compliance with the standards determined within the scope of the Ministry of Health’s Biocidal Products Regulation dated 31 December 2009 and numbered 27449 (4th Bicycle). This regulation establishes mandatory procedures and standards to ensure that biocidal products are placed on the market in a safe and effective manner, taking into account the potential effects of biocidal products on human health and the environment.
Latest Amendments and Their Impact
Significant amendments were made to this regulation, published in the Official Gazette dated December 30, 2021, under number 31705. These changes, aimed at aligning more closely with EU legislation, have streamlined the registration process, including the abolition of provisional application and sealed sampling. The amendments now accept analyses of biocidal products, such as physicochemical tests and efficacy tests, performed abroad under certain conditions.
Steps in Obtaining a License
Obtaining a license for biocidal products in Turkey involves a comprehensive process that DORUKSISTEM adeptly navigates. From preparing the necessary documentation to submitting the application dossier, DORUKSISTEM’s expertise ensures a smooth licensing journey.
DORUKSISTEM acts as a pivotal partner in managing the entire licensing process. Their services include document preparation in compliance with ANNEX IIB, label creation, safety data sheet preparation, and much more, ensuring a thorough and compliant application.
A critical step in the licensing process is preparing a biocidal product license file in accordance with ANNEX IIB format. DORUKSISTEM specializes in crafting these documents to meet all regulatory requirements.
The label and Safety Data Sheet (SDS/MSDS) of the biocidal product are essential components of the application. DORUKSISTEM’s expertise ensures that these documents are accurately prepared, reflecting all necessary safety and regulatory information.
Formulating and specifying documents for biocidal products is a meticulous process. DORUKSISTEM ensures these documents are comprehensive and comply with regulatory standards.
The preparation of the Active Substance Dossier, in line with ANNEX IIA format, is another area where DORUKSISTEM excels, guaranteeing that all active substances in the biocidal product are appropriately documented.
Risk assessment is a crucial part of the application. DORUKSISTEM prepares detailed risk assessment reports according to Annex-VI, covering all potential risks associated with the biocidal product.
DORUKSISTEM meticulously reviews test reports for compliance. If necessary, they facilitate the conduction of these tests, either in Turkey or abroad, to meet the Ministry’s requirements.
The regulation mandates various tests, including physicochemical, stability, and efficacy tests. DORUKSISTEM ensures that these tests are performed accurately and meet the regulatory standards.
A notable amendment to the regulation is the acceptance of foreign test reports under certain conditions. DORUKSISTEM aids in ensuring that these tests, if performed abroad, comply with the requirements set by the Ministry.
Submitting the application dossier to the competent authority is a critical step. DORUKSISTEM not only submits the dossier but also regularly follows up on the application’s progress.
DORUKSISTEM’s proactive follow-up strategies ensure that any issues are promptly addressed and that the licensing process moves forward efficiently.
Once the application process nears completion, DORUKSISTEM guides its clients through the final steps to secure the biocidal product license.
The support provided by DORUKSISTEM doesn’t just stop at submission; they are there every step of the way until the license is obtained.
Aligning with EU legislation is crucial for market success. DORUKSISTEM’s expertise ensures that clients’ products not only comply with Turkish regulations but also meet EU standards.
DORUKSISTEM doesn’t just assist with compliance; they also offer strategic advice on market entry, helping clients navigate the Turkish market landscape effectively.
The registration process can be fraught with challenges. DORUKSISTEM, with its in-depth knowledge and experience, helps clients overcome these obstacles smoothly.
From dealing with bureaucratic hurdles to addressing technical compliance issues, DORUKSISTEM provides solutions that are both practical and effective.
Acting as an Only Representative, DORUKSISTEM offers a range of services that alleviate the burden of regulatory compliance for non-Turkish companies.
In-depth literature reviews and accurate translations are integral to the registration process. DORUKSISTEM excels in providing these services, ensuring that all documents are precisely translated and compliant.
With a team of expert translators, DORUKSISTEM ensures that all necessary documents are accurately translated, reflecting the required technical and regulatory nuances.
Regulatory changes can significantly impact manufacturers and distributors. DORUKSISTEM provides insights into these changes and how they affect market strategies.
With its finger on the pulse of regulatory shifts, DORUKSISTEM guides clients through these changes, ensuring they remain compliant and competitive.
Understanding the cost implications of biocidal product registration is crucial for budgeting. DORUKSISTEM assists clients in estimating these costs accurately.
The timeframe for biocidal product approval can vary. DORUKSISTEM provides clients with realistic timelines, helping them plan accordingly.
Through efficient management and expert knowledge, DORUKSISTEM ensures that the approval process is as streamlined as possible, reducing delays.
Staying ahead of regulatory trends is key. DORUKSISTEM not only predicts future regulatory changes but also prepares clients to adapt to these shifts.
DORUKSISTEM’s support doesn’t end with licensing. They provide ongoing compliance and consultation services, ensuring clients remain up-to-date with regulatory requirements.
In conclusion, partnering with DORUKSISTEM offers a comprehensive solution to navigating Turkey’s biocidal product regulations, ensuring successful market entry and sustained compliance.
FAQs
What is the Turkish Biocidal Products Regulation and why is it important? The Turkish Biocidal Products Regulation, established on December 31, 2009, and recently amended in 2021, sets the legal framework for the sale and distribution of biocidal products in Turkey. This regulation is crucial as it ensures that biocidal products on the Turkish market are safe, effective, and compliant with both national and EU standards. It governs everything from the licensing process to the compliance requirements for these products, playing a vital role in protecting public health and the environment.
How does DORUKSISTEM assist in the biocidal product licensing process in Turkey? DORUKSISTEM offers comprehensive assistance in navigating the licensing process for biocidal products in Turkey. Their services include preparing all necessary documentation in compliance with regulatory requirements, submitting the application dossier to the competent authority, and following up regularly on the application’s progress. They also assist in reviewing and ensuring the compliance of test reports, and their expertise extends to the translation and review of relevant literature.
What are the major challenges in registering biocidal products in Turkey and how does DORUKSISTEM address them? Key challenges in registering biocidal products in Turkey include navigating complex regulatory requirements, preparing compliant documentation, and ensuring the product meets all safety and efficacy standards. DORUKSISTEM addresses these challenges through their deep understanding of the regulatory landscape, meticulous preparation of application documents, and expert guidance throughout the registration process. They streamline the process, making it more efficient and less daunting for companies.
Can DORUKSISTEM handle the submission of application dossiers for foreign companies? Yes, DORUKSISTEM can handle the submission of application dossiers for foreign companies. They offer ‘Only Representative’ services, which allow them to act on behalf of non-Turkish companies in the registration process. This service is particularly beneficial for foreign companies unfamiliar with the Turkish regulatory environment, as DORUKSISTEM navigates the process on their behalf, ensuring compliance and successful market entry.
What are the benefits of DORUKSISTEM’s Only Representative services? DORUKSISTEM’s Only Representative services offer several benefits, including regulatory expertise, ease of communication, and streamlined processes. These services are especially advantageous for companies outside Turkey, as DORUKSISTEM acts as a local representative, bridging the gap between the company and Turkish regulatory authorities. This not only simplifies the registration process but also ensures compliance with Turkish regulations, minimizing the risk of non-compliance.
How does DORUKSISTEM ensure ongoing compliance with the Turkish Biocidal Products Regulation post-licensing? Post-licensing, DORUKSISTEM ensures ongoing compliance with the Turkish Biocidal Products Regulation by providing continuous support and consultation. They keep clients informed of any regulatory changes or updates, assist in maintaining and updating necessary documentation, and offer strategic advice to address new compliance challenges. This proactive approach ensures that clients remain compliant with regulations, safeguarding their market presence and reputation.
License and registration, contact the major documents of the Security Information Forms (GBF), all biocidal products and / or biocidal products used in the active ingredients with the Regulation KKDIK Annex-II should be prepared.
