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KKDIK Lead Dossier Registration
What is KKDIK Lead Dossier?
KKDIK Lead dossier is the main dossier that is submitted by the lead registrant on behalf of manufacturers and importers to the Ministry.
Lead dossier contains all the necessary information regarding the substances, and it is used in the registration process by the other registrants.
Content of KKDIK Lead Dossier
Main subjects of KKDIK Lead Dossier and their description is given in the table below:
| Chemical substance identification and characterization | This includes information such as substance name, CAS number, molecular weight, purity, use areas, and physical and chemical properties. |
| Classification | Classification information, which is used to identify potential effects of a chemical substance on people and the environment, includes information such as hazard categories, hazard statements, hazard pictograms, and precautionary statements. |
| Usage details | KKDIK Lead Dossier includes answers to questions such as use areas, uses in manufacture, uses in formulations, amount of use, exposure potential, conditions for use, storage conditions, waste management and so on. |
| Physico-chemical properties | Physical properties include information on substance state, appearance, melting point, boiling point, vapour pressure, solubility etc., while chemical properties include information on chemical formula, molecular weight, pH, stability, reactivity etc. |
| Toxicologic data | Toxicologic data includes information on acute toxicity, chronic toxicity, mutagenicity, immunotoxicity, neurotoxicity carcinogenicity and so on. |
| Ecotoxicologic data | Ecotoxicological data includes information on toxicity related to the environments, and affects of the substances. |
| Guidance on safe use | Guidance on Safe Use, which is included in the KKDIK lead dossier, is a detailed document containing all the information required for the safe production, use, storage and disposal of a chemical substance. |
| Chemical safety report | The Chemical Safety Report, which is included in the KKDIK lead dossier, is a document that assesses the potential risks of a chemical substance to human health and the environment and specifies the measures needed to manage these risks. |
By sharing this information in the KKDIK Leader dossier, data sharing between companies that produce or import the same chemical becomes easier. This helps companies not only in registration processes but also in ensuring chemical safety.
Phases of the KKDIK Lead Dossier Registration Process
In the Lead Dossier registration process, the steps below are followed:
- Substance Information Exchange Forum (SIEF)
The Substance Information Exchange Forum (SIEF) is a platform where companies that will place the same chemical substance on the market come together to share all the information they have about that substance and create a joint registration dossier.
Thanks to SIEF, repetitive work on the substance is prevented, resources are saved and the registration process is accelerated. - Determination of Lead Registrant
Among the potential registrants who come together during the SIEF process explained above, a person or organization must be determined as the lead registrant.
Lead registrant coordinates the preparation of the registration dossier, cooperates with other registrants and assumes responsibility for the final dossier to be submitted to the Ministry. - Preparation of Technical Dossier
A technical dossier is a comprehensive document containing all information regarding the substances and is an important part of the registration process.
The technical dossier includes information on:
- Identity of the substances
- Physico-chemical properties
- Toxicologic properties
- Ecotoxicological properties
- Information on manufacture and uses
- Information on safety
- Classification and labelling
- Chemical Safety Report
- Data and Cost Sharing
Data and cost-sharing in the KKDIK registration process require significant coordination between the lead registrant and other registrants.
The lead registrant collects all data required to prepare the technical dossier from other registrants. During this process, each registrant transfers their data to the lead registrant.
Cost sharing is usually determined by the amount of the substance released to the market or market share. In this way, all registrants share the burden of the registration process fairly and reduce costs. - Registration Application and Payment
The official process is initiated after all preparations with the registration application and payment, which is the last stage of the KKDIK registration process.
The lead registrant applies for registration to the Ministry with the completed technical dossier and all necessary documents. With this application, the fees specified in the regulation are paid. This payment amount varies according to the amount of the substance, the hazard class and other factors. - Ministry Control
After the application and payment process, the Ministry evaluates the application and conducts the necessary examinations. During this process, additional document requests or additional analyses may be requested. The ministry issues a registration approval or may reject the application as a result of the evaluation. The registration approval indicates that the substances that have been registered within the scope of KKDIK can be placed on the market.
KKDIK Lead Dossier Registration provides security in the management of chemical substances and facilitates the compliance process with the KKDIK Regulation.
It is recommended that companies receive expert support to complete this process, thus preventing possible legal problems.