KKDIK Dossier Registration
What is KKDIK Dossier?
The KKDIK dossier created within the scope of the KKDIK Regulation is a document containing comprehensive information about the safe use of a particular chemical substance.
Why is the KKDIK Dossier Registration Process Important?
The purpose of the KKDIK Dossier is to define safe use conditions by assessing chemical substances’ potential effects on human health and the environment. KKDIK dossiers ensure that people who work with or are exposed to chemical substances are informed about the substances.
With the help of KKDIK Dossier registration process, inspections are facilitated and the competitive power of brands is strengthened.
Who is Responsible for KKDIK Dossier Registration?
According to the KKDIK Regulation, the persons who are obliged to register KKDIK dossiers are as follows:
1 – Manufacturers and importers who manufacture or import the substance, either on its own or in mixtures, in quantities of one tonne or more per year must apply for registration.
2 – If certain conditions apply to monomer substances or other substances in the polymer, the polymer manufacturer or importer must register. These conditions are that the polymer contains 2% or more by weight of monomer material or other substance composed of monomer units and chemically bonded, and the total amount constitutes one tonne or more per year.
3 – Producers or importers of articles must register substances intended for release from those articles.
In the event that these persons do not fulfil their obligations, it is not possible for them to take part in the Turkish market.
How to do KKDIK Dossier Registration?
The first step of KKDIK dossier registration process is to submit an application for registration through the Turkish Chemical Registration System, which is known as KKS.
However, the registration application requires companies to prepare a technical dossier that includes the information below:
• Identity of manufacturers and importers
• Identity of the substance
• Information on the manufacture and uses of the substance
• Classification and labelling of the substance
• Guidance on the safe use of the substance
• Study summaries of information obtained from the application of Annexes 7 to 11
• Comprehensive study summaries of information obtained from the application of Annexes 7 to 11, if necessary.
After the dossier is submitted, the Turkish Ministry conducts a completeness check. If any deficiency is identified, the Ministry may request additional information from the applicant with a defined deadline.
Things to Consider When Preparing a KKDIK Dossier
It is of great importance that the KKDIK dossier is prepared completely in order to avoid any problems during registration. You can measure the quality of your KKDIK dossier using the checklist below.
| Is the dossier compliant with the latest updates of KKDIK? | |
| Has the chemical substance been identified correctly, and has the necessary information been provided completely? | |
| Have all necessary data on chemical substances been collected, such as toxicological data and ecological data? | |
| Has a risk assessment been made by examining the potential risks of the chemical substance in light of the data collected? | |
| Has a Chemical Safety Report been prepared? | |
| Has a Safety Data Sheet been prepared? |
KKDIK Dossier Registration Service
For a complete KKDIK dossier and a successful registration process, it is recommended that companies receive expert support. Our services regarding KKDIK include:
- Determination of the company role and responsibilities under KKDIK
- Management of the full process for substances under the scope of KKDIK
- Determination of chemical characterization of the substances
- Data management and data-gap analysis
- Completion of the pre-registration process
- Monitoring of pre-SIEF and SIEF participant activities
- Monitoring of consortium activities
- Translations, preparation, and compilation of the registration dossier
- Uploading registration dossier to KKS by the chemical assessment experts
- Authoring of CSR
- Establishment of the substance inventory list under Annex-17
- Preparation of Safety Data Sheets
If you have any questions, don’t hesitate to contact us.