PREPARATION OF THE REGISTRATION DOSSIER IN THE KKDIK REGISTRATION PROCESS

Content addition date : 14-05-2025

Under the KKDİK Regulation (Registration, Evaluation, Authorization, and Restriction of Chemicals), individuals and companies who are required to register chemical substances are as follows:

► Manufacturers and importers who produce or import one ton or more of a substance per year:

This obligation covers companies that produce or import chemical substances either alone or in mixtures. In other words, anyone producing or importing one ton or more of a substance annually is required to register under this regulation.

► Manufacturers or importers of monomer substances and other chemicals in polymers:

Polymers themselves are not registered under the KKDİK Regulation; however, monomers or other chemicals in polymers must be registered under certain conditions. These conditions are:

• The polymer contains 2% or more of a monomer substance or another chemically bound substance by weight,
• The total amount of the monomer substance(s) or other substance(s) is one ton or more per year.
   

► Manufacturers or importers of substances intentionally released from articles:

If a substance is intentionally released from an article, the manufacturer or importer of that substance is also required to register. For example, in products where a chemical substance is released during usage, these substances must be registered.

According to the KKDİK Regulation, individuals and companies in these groups are required to submit a registration application. It is not possible to produce or place such substances on the market without submitting a registration application.

Before registering a chemical substance under the KKDİK Regulation, a technical dossier containing specific information must be prepared and submitted for approval by the Ministry. The contents of this technical dossier are summarized as follows:

• Company Information: Basic information such as the name, address, and contact details of the applicant company.
• Basic Information about the Substance: The name, CAS number, chemical formula, and other identifying properties of the chemical substance.
• Information about the Production and Use of the Substance: Detailed information about the production process, application areas, and conditions of use.
• Classification and Labelling Information: Information on the classification and labelling of the substance considering its health, safety, and environmental effects.
• Guidance on Safe Use of the Substance: Recommendations for the safe use of the substance, risk management, and precautions.
• Summaries and Comprehensive Study Records from Annex-7 and Annex-11 of the KKDİK Regulation: Compilation and reporting of the information in Annex-7 and Annex-11.
• Chemical Safety Report (CSR): If the annual tonnage of the substance is 10 tons or more, a Chemical Safety Report must be prepared.

The Ministry reviews the registration applications submitted through the KKS module and conducts a completeness check to verify whether the application is complete. The steps in this process are as follows:

• Completeness Check: The Ministry checks whether the technical dossier submitted by the applicant contains all the necessary information. The goal is to identify any missing information or documents and ensure the completeness of the dossier.
• Completeness Check Duration: The Ministry completes the completeness check within 3 weeks. That is, after the application is submitted, the Ministry will determine whether the dossier is complete within this period.
• Missing Information: If there is any missing information in the technical dossier (such as missing documents or details), the Ministry will request the missing information from the applicant. The applicant is given a specified period to complete the missing information, which must be completed by the deadline set by the Ministry.

Over time, significant changes may occur regarding the registered companies or substances. In such cases, the registered technical dossier may need to be updated. The situations requiring an update are as follows:

• Changes in Company Information: If there are any changes in the company’s name, address, or contact information, these changes must be reported to the Ministry, and the dossier must be updated.
• Changes in Substance Composition: If there are changes in the composition of the chemical substance, the dossier must be updated. For example, if the content or chemical components of the substance change, an update is required.
• Changes in Production or Import Quantities: If there is an increase or decrease in the annual production or import quantity of the registered substance, the registration dossier must be updated.
• Newly Defined Application Areas: If there is a change or addition in the application areas of the substance, this must also be added to the registration dossier.

If any of these changes occur, the registrant must make the updates and notify the Ministry of Environment, Urbanization, and Climate Change. This ensures that the registered substances contain accurate and up-to-date information.

Once the registration dossier is submitted, the KKDİK Regulation allows for updates only in cases where they are required. For example, if errors in the dossier are identified after submission to the Ministry, such as incorrect information, the dossier must be updated. In this case, the reason for the update and the reference to the previously valid registration dossier should be indicated in the dossier title. These types of updates are not subject to any fees.

If the error causes the dossier to fail the suitability check, instead of updating the dossier, a new registration dossier must be submitted as if it were the first submission.

For substances that were previously registered but are no longer produced or imported, the registrant has the obligation to update the registration (Article 22) and maintain the information (Article 32). This means that companies that have stopped manufacturing or importing a substance must report the new total tonnage of the substance as “0 tons/year” to the Ministry.

Additionally, the registrant is required to keep all relevant information for at least 10 years from the most recent date of manufacture, import, supply, or use of the substance (whether alone or in a mixture).