What is KKDIK Dossier Registration?

Under the KKDIK Regulation, which aims to protect human health and the environment during the manufacture, import, and use of chemicals, it is mandatory to register chemical substances produced or imported in Turkey at 1 ton or more per year per manufacturer or importer. KKDIK dossier registration is part of these regulatory requirements. The KKDIK dossier registration process is monitored by the Turkish Ministry of Environment, Urbanization, and Climate Change and must be conducted according to specific criteria.

Who Must Register a KKDIK Dossier?

According to the KKDIK Regulation, the following entities are required to register a KKDIK dossier:

Manufacturers and importers who produce or import a substance on its own or in a mixture at 1 ton or more per year must submit a registration application.
Polymer manufacturers or importers must register under certain conditions for monomer substances or other substances within the polymer. These conditions include the polymer containing 2% or more by weight of chemically bonded monomer units or other substances, with the total quantity amounting to 1 ton or more per year.
Producers or importers of articles must register substances intended for release from those articles.

These entities must register their chemicals as per the KKDIK Regulation. Substances that are not registered cannot be manufactured or placed on the Turkish market.

How to Register a KKDIK Dossier?

The KKDIK dossier registration process consists of the following steps:

1. Registration Application

Companies submit their registration applications through the Chemical Registration System on the official website of the Turkish Ministry of Environment, Urbanization, and Climate Change.

2. Preparation of the Technical Dossier

A technical dossier must be prepared for the registration application. This dossier should include:

Identity of manufacturers and importers

Identity of the substance

Information on the manufacture and use of the substance

Classification and labeling of the substance

Guidance on the safe use of the substance

Study summaries of information derived from the application of Annexes 7 to 11

If necessary, comprehensive study summaries of the information derived from the application of Annexes 7 to 11

3. Completeness Check

The Ministry performs a completeness check on the registration dossiers. However, this check does not evaluate the adequacy or quality of the submitted data or evidence. And if deficiencies are found, additional information may be requested from the applicant.

4. Updating the Registration Dossier

If there are significant developments regarding the registered substance or the registrants, the registration dossier must be updated and the Ministry must be informed. Situations requiring dossier updates include:

Changes in status, such as becoming a manufacturer, importer, or article producer

Changes in identity information, such as name and address

Changes in the composition of substances

Changes in the quantities of the substance produced or imported

Newly identified uses of the substance

5. Requests for Additional Information

If the Ministry requests, the registrant must provide additional information by the date specified by the Ministry.

The KKDIK dossier registration process is completed by following these steps. It is important to provide accurate and complete information throughout the process.

Chemleg Consultancy Services

If companies lack the necessary expertise in chemical registration processes, their registration applications may be rejected, leading to delays in manufacturing or marketing products, or even penalties. To avoid such negative outcomes, companies are advised to seek professional assistance.

Chemleg can support you in your chemical registration processes. Our services related to compliance with the KKDIK Regulation include:

Determining roles and responsibilities under KKDIK
Managing the entire process for substances under KKDIK
Identifying substances within the scope
Conducting pre-registration of substances
Monitoring pre-SIEF and SIEF participant activities
Tracking consortium activities
Preparing and compiling registration dossiers under KKDIK
Uploading registration dossiers to the KKS by chemical assessment experts
Submitting SVHC notifications
Creating inventories of substances under Annex 17 (Restricted Substances List)

Additionally, we support companies in preparing Safety Data Sheets, creating labels and classifications, and providing only representative services.

Click here to access our service page.