KKDIK Joint Registration Dossier
What is the KKDIK Joint Registration Dossier?
Under the KKDIK Regulation, the preparation of a “KKDIK Joint Registration Dossier” aims to reduce costs and share information by allowing multiple parties registering the same chemical substance to conduct their registration processes jointly.
The content of the KKDIK Joint Registration Dossier includes the documents required to be submitted under the KKDIK Regulation and the necessary information for the safe use of the chemical substance. The main components of the dossier can be listed as follows:
- Technical Dossier
The technical dossier contains information such as the identity of the substance, physicochemical properties, toxicological and ecotoxicological data, uses, and safe use guidelines. - Chemical Safety Report (CSR)
The chemical safety report includes risk assessment, risk management measures, operational conditions, and exposure information. - Joint Submission Statement
The KKDIK Joint Registration Dossier should include a statement indicating that the member companies have agreed to make a joint application and share information.
The KKDIK Joint Registration Dossier contributes to reducing the adverse effects on human health and the environment by ensuring the safe use of chemical substances.
What is the KKDIK Joint Registration Dossier?
The KKDIK Joint Registration Dossier is part of the chemical registration process under the KKDIK Regulation. Registration through joint submission is beneficial as it allows companies registering the same chemical substance to optimize information sharing and costs.
According to the KKDIK Regulation, companies manufacturing or importing chemical substances in quantities of 1 ton or more per year, either on their own or in a mixture, are required to register these substances. The joint registration dossier, as described above, can be defined as part of this registration process.
How to Prepare the KKDIK Joint Registration Dossier?
The process of preparing the KKDIK joint registration dossier is completed by companies working together to gather the necessary information, prepare the dossier, and submit it to the Turkish Ministry of Environment, Urbanization, and Climate Change. The KKDIK joint dossier registration process can be summarized as follows:
- Formation of SIEF (Substance Information Exchange Forum)
SIEF is a forum where companies wishing to register the same chemical substance come together to share information and reduce costs. This forum is created when manufacturers and importers contact other companies conducting the registration process for the same substance before the registration process. - Pre-Registration and Information Sharing
The pre-registration process involves submitting basic information about the substances to the relevant Ministry. In this step, companies come together to share data by declaring the substance to be registered. This allows the existing information about the chemical to be gathered. - Preparation of the KKDIK Joint Registration Dossier
In this step, the registration dossier to be submitted to the Ministry is prepared. The content of the registration dossier is as mentioned above. - Submission of the Dossier
Once the KKDIK joint registration dossier is prepared, it is submitted to the Ministry by the Lead Registrant through the KKS. The Ministry evaluates this dossier to check if additional information or corrections are necessary. If there are missing or incorrect details, companies are asked to make the necessary corrections. - Obtaining the Registration Certificate
Once the dossier is accepted, a registration number is issued for the chemical substance. This number indicates that the chemical can be legally marketed and used in Turkey.
What is the KKDIK Joint Registration Fee?
The KKDIK joint registration fee for 2024 depends on the tonnage and the size of the company. Detailed information is available on the website of the Revolving Fund Management of the Turkish Ministry of Environment, Urbanization, and Climate Change.
For more information about the KKDIK Joint Registration Dossier preparation process, please contact us.
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