DORUK SİSTEM

Chemical Regulatory Compliance and Sustainability Services

Our main areas of work are to implement the latest chemical regulatory compliance and sustainability implemented in TURKIYE and in the world to carry out harmonization studies to create infrastructure for relevant certifications to provide training for continuous development and to provide all kinds of necessary support in order to control threats to humans and the environment.

KKDIK

As Doruksistem AS, we provide the necessary resources and expertise to fulfill your obligations under the KKDIK and SEA regulations.

The KKDIK regulation encompasses the registration, evaluation, authorization, and restriction of chemical substances in Turkey. Under this regulation, chemical substances need to be registered, evaluated, and authorized. Doruksistem AS can manage these processes on your behalf and ensure compliance with the requirements.

The SEA regulation, on the other hand, focuses on the classification, labeling, and packaging of chemical substances. Under this regulation, chemical substances must be classified according to their hazards and labeled and packaged accordingly. Doruksistem AS can manage these processes on your behalf and ensure compliance with the requirements.

As Doruksistem AS, we can provide the following services related to the KKDIK and SEA regulations:

– Management of chemical substance registration and authorization processes
– Determination of hazard classification, labeling, and packaging requirements
– Generation of appropriate labels and safety data sheets
– Tracking of registration and notification processes for chemical substances
– Compliance audits and reporting for KKDIK and SEA regulations
– Training and consulting services

We can work with our expert team at Doruksistem AS to fulfill your obligations under the KKDIK and SEA regulations. Please contact us for more information and to take advantage of our services.

As mentioned, Doruksistem offers Only Representative services for compliance with the KKDIK regulation in Turkey. We can assist you with the pre-registration and registration obligations under KKDIK by compiling and submitting the necessary dossiers to the Turkish Ministry of Environment, Urbanization and Climate Change (MoEUCC) as your Only Representative (OR)

Our Only Representative services include:

1. Pre-registration: We will help you pre-register your substances by the deadline of 31 December 2030. This involves submitting the necessary information about the substances and your role in the supply chain through the Ministry’s Chemical Registration System Portal (KKS).

2. Registration: We will guide you through the registration processes, which will end on 31 December 2026 for substances of 1000 tons and above per year, on 31 December 2028 for substances between 100-1000 tons per year, and on 31 December 2030 for substances between 1-10 tons. We will prepare the substance registration dossiers on your behalf and submit it to the MoEUCC.Our team of certified specialists (KDUs) will ensure that the dossier includes all the required information in accordance with KKDIK requirements. As per KKDIK, the safety information must be submitted in Turkish language to the Ministry, and we will handle this for you.

3. Only Representative (OR) services: If you are located outside Turkey, we can act as your Only Representative in Turkey for pre-registration and registration purposes. This means that we will fulfill the obligations on your behalf, ensuring compliance with KKDIK.

By utilizing our OR services, you can simplify the KKDIK compliance process and ensure that your substances are properly pre-registered and registered in Turkey. Our team of experts will handle all the necessary steps and documentation, allowing you to focus on your core business. Please contact us for more information and to discuss how we can assist you as your Only Representative  service provider.

Thank you for providing additional information regarding the SEA notification requirements under KKDIK in Turkey. DorukSistem AS can assist you with the SEA notification process as your Legal Representative or service provider.

Our services include:

1. C&L Notification: We will help you with the Classification and Labelling (C&L) notification process for hazardous substances and hazardous polymers placed on the Turkish market. We will ensure that the necessary information is provided to Turkish Ministry of Environment Urbanization and Climate Change (MoEUCC) in compliance with KKDIK requirements.

2. Legal Representative service: If your company is located outside Turkey, we can act as your Legal Representative in Turkey for SEA notification purposes. This means that we will fulfill the obligations on your behalf, ensuring compliance with KKDIK. We will handle the SEA notification process for your importers so that they do not have to do it themselves.

3. Labelling services: We can provide labelling services to ensure that your products comply with the labelling requirements under KKDIK. Our team will ensure that the correct hazard pictograms, signal words, and other required information are included on the labels.

4. Consultation: We are available to provide consultation and guidance on the SEA notification requirements and any other aspects of KKDIK compliance. Our team of experts will answer your questions and help you navigate the regulatory landscape in Turkey.

By utilizing our services, you can ensure that your hazardous substances and non-hazardous substances subject to KKDIK registration are properly SEA notified in Turkey. Our team will handle all the necessary steps and documentation, allowing you to meet your compliance obligations. Please contact us for more information and to discuss how we can assist you as your Legal Representative or service provider.

As DorukSistem AS, we also offer Only Representative (OR) services to non-Turkish manufacturers who wish to comply with the Regulation on the Registration, Evaluation, Authorization, and Restriction of Chemicals (KKDIK) in Turkey.

The KKDIK regulation requires non-Turkish manufacturers to appoint an OR when they want to supply their chemical substances or mixtures to the Turkish market. We can act as your legal representative within Turkey and fulfill the obligations under KKDIK on your behalf.

Our OR services include:

– Pre-registration and registration: We can handle the pre-registration and registration process for your chemical substances with the Turkish Chemicals Registration and Evaluation Agency (KİM) as the OR.
– Data sharing and dossier preparation: We can assist in data sharing negotiations and prepare the necessary registration dossiers in compliance with KKDIK requirements.
– Substance identification and classification: We can help identify and classify your substances according to the KKDIK regulations.
– Communication with authorities and downstream users: We can handle all communication with the relevant authorities and downstream users, including responding to inquiries and providing necessary documentation.
– Compliance monitoring: We will monitor and ensure ongoing compliance with KKDIK obligations, such as substance volume tracking and updates to registration dossiers.
– Representation in SIEF and consortia: We can represent your interests in Substance Information Exchange Forums (SIEFs) and consortia, facilitating communication and collaboration with other stakeholders.

By utilizing our OR services, you can continue to supply your chemical substances or mixtures to the Turkish market while ensuring compliance with the KKDIK regulation. Please contact us for more information and to discuss how we can assist you as your Only Representative.

If you are looking to change your Only Representative (OR) for KKDIK compliance, there are a few steps you can follow:

1. Identify a new OR: Research and identify a new OR that meets your requirements and has the necessary expertise in KKDIK compliance.

2. Notify the current OR: Inform your current OR about your intention to change and discuss the process for transferring the responsibilities to the new OR.

3. Terminate the agreement: Review the terms of your agreement with the current OR and follow the termination process outlined in the agreement. Make sure to comply with any notice periods or other contractual obligations.

4. Sign a new agreement: Once you have chosen a new OR, negotiate and sign a new agreement with them. Make sure that the agreement clearly outlines the responsibilities, obligations, and scope of work for the new OR.

5. Transfer the necessary information: Provide the new OR with all relevant information, documentation, and data related to your substances and KKDIK compliance. This will enable them to fulfill their obligations effectively.

6. Update registrations: Work with the new OR to update your substance registrations under KKDIK. They will handle the necessary steps to ensure compliance with the regulations.

It is important to note that changing your OR may involve legal and contractual considerations. It is recommended to seek legal advice and consult with both the current and new OR to ensure a smooth transition.

DORUKSISTEM is ready to offer more effective and reliable solutions with its certified and experienced Chemical Assessment Specialists (KDU/CAS). It will be enough to contact us.

GBF/SDS

Doruksistem GBF Services specializes in helping companies comply with the Turkish SDS Regulation: GBF. This regulation, which came into effect on 15 December 2014, requires companies to align their Turkish Safety Data Sheets (SDSs) with the GBF regulation.

The regulation lost its validity after 31 December 2023 and as of 01 January 2024, all safety data sheets will be prepared in accordance with ANNEX-II of the Registration, Evaluation, Authorization and Restriction of Chemicals (KKDİK) Regulation.

As a result, after December 31, 2023, Safety Data Sheet Preparers were replaced by Chemical Assessment Specialists (CAS).

This ensures that the SDSs are in compliance with the local requirements and can effectively communicate the necessary safety information to users.

Importers in Turkey and manufacturers in Turkey are also obligated to submit a copy of their SDSs to the Ministry of Environment Urbanization and Climate Change (MoEUCC) via the KKS tool. This further ensures that the necessary safety information is available to the authorities and relevant stakeholders.

At Doruksistem KKDIK GBF Services, we have a team of certified experts and a dedicated office in Istanbul.

We are fully equipped to assist you with the preparation and certification of your Turkish SDSs. Our experts have in-depth knowledge of the KKDİK regulation and are well-versed in the requirements for SDS preparation and submission.

By availing our services, you can ensure that your SDSs are compliant with the Turkish regulations, accurately represent your products, and effectively communicate the necessary safety information. We understand the importance of meeting regulatory requirements and can guide you through the process to ensure a smooth and hassle-free experience.

If you require assistance with the preparation and certification of your Turkish SDSs, Doruksistem KKDIK GBF Services is here to help. Contact us today to discuss your specific needs and benefit from our expertise in SDS compliance.

We can work with our expert team at Doruksistem to fulfill your obligations under the KKDIK Annex-II GBF regulation. Please contact us for more information and to take advantage of our services.

Navigating the Complexities of Turkish KKDIK Annex-II Regulation

Regulatory compliance is a crucial element of business operations, especially in sectors involving chemicals or substances that pose a potential risk to human health and the environment. When it comes to managing chemical risks in Turkey, the key regulatory framework is the KKDIK (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulation. Adopted in 2017, KKDIK is Turkey’s equivalent to the EU’s REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulations, aiming to protect human health and the environment from the potential harm caused by chemicals. 

KKDIK regulation, which fully came into effect on December 31, 2023, mandates companies that manufacture or import substances in Turkey to register these substances with the Turkish Ministry of Environment Urbanization and Climate Change (MoEUCC). The regulation applies to substances manufactured or imported in quantities of one ton or more per year, including substances in mixtures or articles intended to be released.

KKDIK Annex-II: What Is It?

Annex II of the KKDIK regulation outlines the requirements for compiling safety data sheets (SDSs). SDSs are vital documents that provide information about the properties of substances, including their hazards and instructions for handling, storage, and emergency measures in case of an accident. These SDSs must be supplied by the manufacturer or importer to the downstream users of the substances.

The purpose of Annex-II is to ensure that the necessary data concerning these substances or mixtures are available within workplaces. It is an essential part of the broader KKDIK regulatory framework, supporting its main aim of safeguarding human health and the environment from the potential hazards posed by chemicals.

KKDIK Annex II is subdivided into 16 sections, each providing different details about the substance in question. Here’s a quick overview of the sections:

  1. Identification of the substance/mixture and of the company/undertaking.
  2. Hazards identification.
  3. Composition/information on ingredients.
  4. First-aid measures.
  5. Firefighting measures.
  6. Accidental release measures.
  7. Handling and storage.
  8. Exposure controls/personal protection.
  9. Physical and chemical properties.
  10. Stability and reactivity.
  11. Toxicological information.
  12. Ecological information.
  13. Disposal considerations.
  14. Transport information.
  15. Regulatory information.
  16. Other information.

Each of these sections serves an integral role in providing a comprehensive profile of the substance or mixture and how to manage potential risks and hazards associated with its use.

Importance of Compliance

Compliance with KKDIK Annex-II is not just about regulatory adherence; it’s also about creating safer workplaces. By providing detailed information on substances and their potential hazards, it supports companies in educating and protecting their employees. Furthermore, non-compliance can lead to significant penalties, including fines and restrictions on business operations.

Final Thoughts

Understanding and adhering to regulatory standards like KKDIK Annex-II can seem daunting, but it is an essential aspect of responsible business practice. As these regulations continue to evolve, businesses must stay informed and agile, ensuring their operations remain compliant and safe.

In the complex world of chemical regulations, having the right expertise and support can make all the difference. Companies are advised to partner with knowledgeable consultants and use sophisticated chemical management software to navigate these complexities successfully. By doing so, they can both safeguard their business interests and contribute positively to human health and environmental protection.

Safety Data Sheets (SDSs) are critical documents that provide comprehensive information about the properties of a substance or mixture, including hazards and instructions for handling, storage, and emergency measures in case of an accident. They serve as an essential resource for professionals managing chemical safety in various workplaces.

The KDU or Chemical Assessment Specialist (CAS) plays a pivotal role in the development of these SDSs. It provides a detailed assessment of the substance’s properties, including its physical, chemical, toxicological, and ecological characteristics. The risks and hazards identified during the KDU inform the precautions and safety measures detailed in the SDSs, ensuring that they are appropriate and effective.

Thus, the KDU is vital not just for the KKDIK registration process, SEA notifications, and Chemical Safety Reports, but also for creating comprehensive and accurate Safety Data Sheets. By providing an in-depth understanding of a substance’s properties and potential impacts, the KDU helps to ensure that all safety measures and regulations associated with the substance are based on sound scientific evaluation.

A Chemical Assessment Specialist, also known as a Chemical Risk Assessor or Chemical Evaluator, plays a pivotal role in understanding and managing the risks associated with chemical substances. This is a highly specialized role that requires deep knowledge in chemistry, toxicology, environmental science, and regulatory affairs.

Roles and Responsibilities:

  1. Risk Assessment:

    A Chemical Assessment Specialist conducts risk assessments for chemical substances. This involves identifying the potential hazards associated with a substance, evaluating the likelihood of exposure, and assessing the risks posed to human health and the environment.

  2. Safety Data Sheet (SDS) Preparation:

    Chemical Assessment Specialists play a crucial role in preparing SDSs. They gather and interpret data on a substance’s properties, hazards, and safety measures, which is then compiled into the SDS. The SDS serves as a primary source of information for managing chemical safety in workplaces.

  3. Regulatory Compliance:

    Specialists in chemical assessment help ensure that an organization complies with all relevant chemical regulations, such as Turkey’s KKDIK or the EU’s REACH. This involves not only conducting the necessary assessments and documentation but also keeping up to date with changes to regulations and understanding their implications.

  4. Liaison with Regulatory Bodies:

    Chemical Assessment Specialists often act as the point of contact between their organization and regulatory bodies. They may be responsible for submitting necessary documents, responding to queries, and negotiating on issues related to chemical safety and regulation.

  5. Training and Guidance:

    Given their expertise, Chemical Assessment Specialists often provide training and guidance to other staff within their organization on chemical safety and compliance issues. They may also contribute to the development of internal policies and procedures related to chemical management.

Qualifications and Skills:

A Chemical Assessment Specialist typically holds a degree in chemistry, toxicology, environmental science, or a related field. They need to have a thorough understanding of chemical properties and behaviors, toxicology, exposure pathways, risk assessment methodologies, and chemical safety regulations.

Skills required for this role include data analysis, report writing, problem-solving, communication, and project management. Familiarity with specialized software tools used for chemical risk assessment can also be beneficial.

In conclusion, a Chemical Assessment Specialist plays a crucial role in managing chemical safety and regulatory compliance within an organization. They combine their scientific knowledge with a deep understanding of regulatory requirements to assess and manage the risks posed by chemical substances. Their work helps to protect both human health and the environment from potential harm.

BPR (TR)

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:

  1. 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.

  2. 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.

  3. 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.

  4. 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:

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  1. 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.

  2. 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.

  3. 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.

  1. 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.

  2. 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.

  3. 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

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Chemicals Management with Doruksistem

The chemicals, which we encounter in many areas of our daily life and are exposed to in different ways, need to be managed in a correct and healthy way, from the manufacture to the use of the consumer.

Chemicals used in many business lines such as paint, pharmaceuticals, plastics, textiles, electrical automotive, defense and aerospace provide us with countless conveniences, but also bring many risks.

Therefore, the way to market a chemical product in the target market in a healthy way is to analyze all the risks and benefits related to it. Obtaining accurate data, making them available to the relevant market, but protecting trade secrets requires experience and deep knowledge.

In all these processes, as Doruksistem, in Turkey and the world market, we analyze your needs and together we prepare the best roadmap for the management of the process. Since 2005, we have always added value to the sector with respect, dedication and meticulousness, and we continue to do so.

You can find detailed information about our works by visiting our other sites.

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Do You Need an Only Representative in Turkey?

Institutions and organizations that want to sell more than 1 ton of chemicals per year to Turkey are required to register within the scope of the Registry, Evaluation Permit and Restriction of Chemicals (KKDIK) Regulation and to obtain legal permission from the Ministry of Environment, Urbanization and Climate Change. Since chemicals that have not been registered after 31/12/2023 cannot be put on the market, your registration will be carried out with a legal representative in Turkey. 

DORUKSISTEM provides Only Representative services to international companies that manufacture abroad and send substances to Turkey alone, in mixtures or in articles. If you are a manufacturer, importer or downstream user in Turkey, DORUKSISTEM is with you.

Do you intend to change your Only Representative for a privileged professional KKDIK management?

DORUKSISTEM is ready to offer more effective and reliable solutions with its certified and experienced Chemical Assessment Specialists (KDU/CAS). It will be enough to contact us.

How can we help you?

With over 20 years of consultancy and training experience in Regulatory Compliance and Sustainability Services, strong communication ability with local and international authorities, and experienced staff consisting of chemical evaluation experts, Doruksistem provides the only representative service to more than 200 companies at the highest level since the publication of the KKDIK regulation.

Our Services for Local and Global Responsible Persons within the scope of KKDIK (Turkey REACH);

  • Determination of roles and responsibilities within the scope of KKDIK
  • Managing all processes on behalf of Manufacturers, Importers and Downstream users for substances within the scope of KKDIK
  • Determining the items in scope and creating process policies
  • Substance Pre-Registration
  • Follow-up of pre-SIEF and SIEF participant activities
  • Follow-up of consortium activities
  • Preparation of registration files and compilation within the scope of KKDIK
  • Uploading the registration file to KKS by chemical assessment experts
  • Establishing a substance inventory within the scope of Annex-17 (Restricted Substance List)
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Sectors We Work

DORUK SİSTEM

VISION OF THE DORUKSISTEM

WHAT TO EXPECT IN KKDIK AND REACH?

KKDIK in our country and the regulations known as REACH within the borders of the European Union are the most important legal elements in the current situation for all manufacturers and chemical importers. Based on the toxic, ecotoxicological and physico-chemical risks that each chemical may cause, these legal elements specify the rules and responsibilities that manufacturers and importers must comply with in a structured order and ask them to comply with the relevant conditions. The REACH regulation in the EU has been serving with all its functions since 2018, and the KKDIK regulation published in 2017 in our country has been put into service with all its functions as of 31.12.2023.

You can contact us for all our services related to KKDIK.

HOW DOES DORUKSISTEM SUPPORT YOU?

Doruksistem makes these processes easier for you with its 18 years of industry and consultancy experience. With its staff consisting of Chemical Assessment Specialists (CAS/KDU) who have gained experience in KKDIK LR & CoR registrations, SIEF coordination and management,  GBF Compliance into TR Regulation, R&D quality-assurance, laboratory, manufacturing and management consultancy functions in sectors such as plastics, paints and pharmaceuticals, all of which are mainly chemicals, and its infrastructure with an international consultancy network, it is a priority to examine all chemical management processes of your company as a whole. After issuing an evaluation report, we monitor the whole process with great care and importance by performing your pre-registration, sea-notification, final registration and updates in the KKS (Chemical Registration System) software, the digital platform of the Ministry, we intervene within your permission and give you written feedback.

WHAT DO WE OFFER TO YOU BEYOND KKDIK REGISTRATIONS ?

In addition, we also provide services for the preparation of SDS (Safety Data Sheets) that your company may need, consultancy services that will enable you to take precautions against possible risks related to road transport of dangerous chemicals such as ADR, and the creation of license files for your biocidal and cosmetic products.

In addition to these, among our new services, we also have consultancy packages that will allow you to benefit from Government Incentives. We offer you consultancy with our professional team so that you can benefit from all incentives under the headings of investment, R&D and export for our SMEs and large enterprises.

In addition to all these, we contribute to you with lean management techniques, process analysis and 6 sigma trainings for the improvement and development of your business processes.

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You can contact us for our services about Chemical Management Systems, Regulatory Compliance and Sustainability