Importer Responsibilities under KKDIK: Key Information

Dear Importer,

We are writing to inform you about your importer responsibilities under KKDIK (the Turkish Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals).

KKDIK is a regulation established to assess and control the effects of chemical substances on human health, the environment and public health in general. As an importer, you must fulfil the following responsibilities in accordance with the KKDIK Regulation:

Registration of Chemical Substances under KKDIK

General Information

Registering the chemical substances you import is essential for complying with KKDIK requirements.
Under the KKDIK Regulation, registration applies to “substances” only.
Under the KKDIK Regulation, one dossier is prepared for each substance.
This dossier is prepared jointly with the other companies manufacturing and importing the same substance through the Substance Information Exchange Forum (MBDF) for that substance and submitted to the Ministry.
MBDF members communicate with each other to select a Lead Registrant, and the dossier for the substance is prepared and submitted to the Ministry by this Lead Registrant. The registration dossier is completed after review and approval by the Ministry, and a KKDIK registration number is assigned for the substance.
All co-registrants other than the Lead Registrant register jointly with the Lead Registrant.
Registration is the first and most important of the importer responsibilities. To complete your KKDIK registration, you should carefully review and carry out the steps described in detail below.

Pre-Registration Preparation

Company Registration Preparation

First, your company must be registered in the EÇBS system of the Ministry of Environment, Urbanisation and Climate Change. This is done by the company’s authorised representative at https://ecbs.cevre.gov.tr/ (in Turkish). The necessary instructions are available on the site.
Once your registration in the EÇBS system is complete, your company representative must be assigned as an authorised user in the Chemicals Registration System (KKS) application.
Before registering, we recommend reviewing the Chemicals Help Desk website in detail. All necessary steps are described in the guidance documents: https://kimyasallar.csb.gov.tr/ (in Turkish).

Substance Registration Preparation

List the substances you import and will register in an Excel spreadsheet.
This list must be prepared on a substance basis. If a substance is imported in a mixture or an article, you should identify the substances in the product by contacting the manufacturers or reviewing the Safety Data Sheets, and then calculate the annual import volumes per substance.
The list should include the chemical name, EC number and CAS number of the substance, the import volumes for the last three years and the average import volume calculated in accordance with the regulation, the hazard classification under the SEA Regulation (Turkish CLP) and the name of the non-Turkish company you import from.
Review the list to determine whether each chemical substance you import needs to be registered under KKDIK. You can add this information in a separate column. (It is important to check, for example, whether the substance is exempt from registration under KKDIK or whether the average annual import volume is below 1 tonne.)
Remember that, because of your C&L (S&E) notification obligation under the SEA Regulation, the list should also include substances below 1 tonne.
If you use Safety Data Sheets (SDS) in this work, remember to request from the manufacturer Turkish-language SDSs prepared in accordance with the KKDIK Regulation.
Contact your non-Turkish manufacturer and ask in writing whether it has appointed an Only Representative in Türkiye in accordance with Article 9 of the KKDIK Regulation or carried out any other work and, if not, what its intentions are.
If your non-Turkish supplier has fulfilled its KKDIK obligations, you should ask it to add you as an importer.
For this to be done, you must appear in the system as having made your pre-MBDF notification. Only in this way can you be defined as a downstream user and have your registration obligation fulfilled.

Pre-MBDF Registration and C&L (S&E) Notification

For chemical substances subject to registration, you must start the registration process.
To apply for registration, you must submit an online pre-application containing pre-MBDF and C&L (S&E) information through the Chemicals Registration System (KKS) in the EÇBS system.
During the application, you must also provide information such as the chemical properties, hazard classification and labelling information of the chemical substance.
For the substances in your list that fall under KKDIK and that you have decided to register, complete your pre-MBDF registration following the C&L notification in order to become a member of the MBDF for that substance.
After doing so, check in the “Submitted Substances” menu of the KKS system that your pre-registration and C&L notification have been completed, obtain your pre-MBDF registration number for each substance and add it to the list prepared during registration preparation.

KKDIK Registration Process

After submitting your pre-MBDF application, staying in contact with the other pre-MBDF members is important for the registration process.
First, if the non-Turkish company from which you import the substance has completed the registration process under KKDIK, make sure that it has registered you as an importer, as described above.
In this case, contact the appointed Only Representative for information on the registration process and request the registration number once registration is complete; you do not need to continue with registration yourself.
Add your KKDIK registration number to your list and mark it as completed.
If a substance on your list that you intend to register under KKDIK will not be registered by the company you import from, and you intend to continue importing it, the registration obligation lies with you, and you must follow the MBDF that will be set up, through the pre-MBDF for that substance, to prepare the registration dossier.
We recommend that you carefully read the article we have prepared on this subject (in Turkish) and the following guidance documents on the Chemicals Help Desk (in Turkish):
- Rules on joint submission of data and data sharing under the KKDIK Regulation
- Data Sharing Guidance
First, check whether a Lead Registrant has been appointed in the pre-MBDF for the substance. If so, contact the Lead Registrant to ask about the status of the dossier and state your intention to continue as a co-registrant. It is important to make sure that the Lead Registrant acts in a fair, transparent and non-discriminatory manner in accordance with the above guidance. You can discuss and raise this on the common platforms of the MBDF members.
Continuing as a co-registrant (CoR) can be quite costly. We therefore recommend that you carefully review and question the Letter of Access costs in contact with the other MBDF members and act together.
In this case, you will need to purchase a Letter of Access (LoA) from the Lead Registrant (LR) for the dossier information required to complete your registration. Please review the above guidance carefully in this respect.
To complete your registration as a co-registrant (CoR), once the LR has given its approval, you can complete the registration in the KKS system under the co-registrant menu by providing the other information requested.
Once the registration application has been accepted, you will receive the registration number for the chemical substance. This number shows that the substance is registered and imported in accordance with KKDIK requirements.
If no Lead Registrant has been appointed in the pre-MBDF system, you may also proceed with registration as the Lead Registrant.
In this case, you need to have all the information required in the registration dossier for the substance, and we recommend obtaining consultancy for this work. Consultancy may also be needed to prepare a co-registrant dossier and to communicate with non-Turkish manufacturers.
The registration timeline may vary depending on the tonnage of the chemical substance, and registrations may need to be updated over time.
This detailed explanation will help you better understand your importer responsibilities for registering chemical substances under KKDIK. Of course, factors such as the properties and tonnage of the substance may affect the details of the registration process. You can obtain more comprehensive information by reviewing the relevant articles of KKDIK and following current legislation.

Chemical Safety Assessment

Carrying out a safety assessment of the chemical substances you import is part of your importer responsibilities and involves assessing potential risks to human health, the environment and other living organisms.
A chemical safety assessment allows you to identify the hazardous properties of the substance and to assess potential risks on that basis.
You should classify the hazards of the substance and determine appropriate safety measures, taking into account its physical, chemical and toxicological properties.
You should take the necessary measures based on the results of the safety assessment, for example by defining and implementing appropriate safety measures for the transport, storage and use of hazardous chemical substances.
During the safety assessment process, you should prepare documents such as safety data sheets, test reports, working procedures and emergency plans.
You should report the results of the safety assessment to the relevant authorities when required.

Communication with the Non-Turkish Manufacturer

Many importer responsibilities depend on information from the supply chain. It is important to stay in regular contact with the non-Turkish manufacturer to verify the registration status of the chemical substances you import and to obtain up-to-date information.
By contacting the non-Turkish manufacturer, you need to verify whether the substance has been registered under KKDIK or whether a registration application has been made.
You should request information from the manufacturer or supplier such as the registration number of the substance, chemical safety documents and updates.
Throughout your contact, you should follow updates and obtain information whenever there is a change in registration status.
You should make sure that you have the risk communication documents provided by the manufacturer or supplier, such as the hazard classification, labelling information, safety data sheets and chemical safety reports of the substance.
The manufacturer or importer must verify that the chemical substance has been properly registered or that a registration application has been made.
In addition, it is important to contact the relevant bodies or persons to verify whether the manufacturer has appointed an Only Representative under KKDIK or is following KKDIK-related work.
You can obtain accurate and up-to-date information by working with a consultancy company or an authorised organisation that has this information.

Monitoring Restrictions

Monitoring the restrictions laid down by KKDIK is one of the importer responsibilities.
You should identify the restrictions applicable to the chemical substances you import and comply with them in full.
KKDIK may impose restrictions on the manufacture, use, export or import of certain chemical substances. These may take the form of limits on the use of hazardous substances, bans on certain substances or requirements for specific authorisations.
You should regularly review the KKDIK Regulation and the relevant guidance to identify and keep track of the applicable restrictions.
You should assess whether the chemical substance is suitable for its intended use and take appropriate measures in light of the restrictions.
As an importer, you should stay in active contact with your suppliers and take the necessary measures to prevent prohibited or restricted uses.
Staying in continuous contact with suppliers to obtain current and accurate information makes it easier to monitor restrictions. It is also important to review the KKDIK Regulation and the relevant guidance regularly for up-to-date restriction information.

Risk Communication and Information Sharing

It is important to share up-to-date safety information on the chemical substances you import regularly with your suppliers and downstream users.
Safety information includes the hazardous properties, hazard classification, instructions for use, labelling information and appropriate safety measures for the substance.
As an importer, you should request the current safety data sheets, test reports and other relevant documents for the substance from your supplier.
You should also share your Safety Data Sheets with your downstream users so that they understand the potential hazards of the substance, use it safely and apply the relevant safety measures.
An SDS (Safety Data Sheet) is a document that sets out in detail the hazardous properties, instructions for use and safety measures for a chemical substance.
You should request SDSs from your suppliers for the chemical substances you import and pass this information on to your downstream users.
Using up-to-date SDSs is essential, as it ensures that safety-related information on the substance is communicated accurately and on time.
Whenever there is a change in the hazardous properties, instructions for use or safety measures of the substance, the updated information must be shared quickly and the persons concerned informed.
As an importer, you should request from your suppliers Turkish-language safety data sheets that comply with the KKDIK Regulation and have been prepared and approved by certified Chemical Assessment Specialists (KDU), and pass them on to your downstream users.
Sharing accurate and up-to-date documents such as SDSs ensures the safe use of the chemical substance and helps prevent possible risks.
Regularly updating and sharing safety information and ensuring that downstream users have access to it therefore plays a critical role in KKDIK compliance and is your legal responsibility.
Registering your Safety Data Sheets on the Safety Data Sheet platform in the EÇBS system is also one of your legal importer responsibilities.

Record Keeping

It is important to keep all import-related documents and records for a certain period. These documents should be kept to demonstrate compliance with KKDIK requirements and for use in inspections.
Documents related to the import process may include import declarations, invoices and payment records, registration documents for the chemical substances, safety reports, test reports, up-to-date SDSs and other relevant documents.
The retention period may be set by the KKDIK Regulation or by local legislation. In general, keeping documents for at least 10 years is recommended.
Documents must be recorded regularly and stored in an easily accessible and secure way. If they are stored electronically, it is important to ensure data security and protection against unauthorised access.
Keeping documents is important so that they can be presented during inspections or when required. Presenting complete and accurate documents during inspections is critical for verifying KKDIK compliance.
Keeping documents regularly and recording all relevant documents completely is one of the importer responsibilities under KKDIK.

Fulfilling these importer responsibilities protects your access to the Turkish market. Remember that complying with the requirements of the KKDIK Regulation is essential both for meeting legal obligations and for ensuring the safe use of chemical substances.

Substances without a temporary or full KKDIK registration number may not be placed on the Turkish market.

Please do not hesitate to contact us with any questions or for more information. We will be happy to help.

Kind regards,

Doruksistem A.Ş.
KKDIK Compliance Team

Information on Importer Responsibilities under the KKDIK Regulation